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2011-04-15T09:46:00.000-07:00

Back after a month away. The follwing item appeared todaty that is directly related to the last item we posted here.

FDA's Medical Device Review Scrutinized at Senate Hearing

Recent study suggests that high-risk medical devices were recalled at a rate of 1.4 devices for every one U.S. resident in the first six months of 2010

WASHINGTON - Today, U.S. Senator Herb Kohl, Chairman of the Special Committee on Aging, held a hearing examining the Food & Drug Administration's (FDA) role in protecting patient safety as part of the medical device approval process. The panel featured testimony from Marcia Crosse, Ph.D., Director of the Health Care Team at the Government Accountability Office (GAO). Crosse's testimony outlined the preliminary findings of an ongoing GAO investigation into the FDA's management of medical device review, post-market monitoring and recall processes.

"Concerns persist about the effectiveness of the 510(k) process in general, including its ability to provide adequate assurance that devices are safe and effective," Crosse said in her testimony. "Gaps in FDA's postmarket surveillance show that unsafe and ineffective devices may continue to be used, despite being recalled."

Kohl opened the hearing by emphasizing that "the FDA must constantly strive to maintain a delicate balance between safety and innovation."

"The drive toward getting new technologies to market shouldn't be done at the risk of patient safety," Kohl said. "Faulty medical devices, especially those implanted in the body, can have a disastrous impact on the health of those who use them."

Internal reviews by FDA officials and other outside sources have found troubling lapses in the procedures by which a number of medical devices were approved. The results of these investigations caused procedural and management changes to be implemented at the Center for Devices and Radiological Health in recent months.

The medical device industry is concerned that these management problems have slowed medical device innovation. In his testimony today, David Nexon, Senior Executive Vice President of the Advanced Medical Technology Association, criticized that there are, "inefficiencies at FDA that delay patient access to new treatments and cures and erode U.S. global competitiveness in the development of medical technology."

"I am encouraged by the numerous initiatives that FDA is implementing for more effective medical device approval and post-market surveillance," Kohl said. "Nevertheless, I'm concerned that the agency's oversight of medical products still remains on the GAO's 'high risk' list... and that is unacceptable."

GAO flagged the FDA's management of medical devices with a "high risk" designation in 2009.
The hearing highlighted the story of Ms. Katie Korgaokar, a Denver resident who received a DePuy ASR hip implant to treat a congenital condition called Perthes disease. In 2010, the DePuy hip was recalled and Korgaokar endured a second hip-replacement surgery in early 2011. Korgaokar was one of 96,000 patients affected by the DePuy hip recall.

A recent study, led by Diana Zuckerman, Ph.D. and published in the Archives of Internal Medicine, found that "from 2005 through 2009, the 113 highest-risk device recalls involved 112.6 million recalled products." Zuckerman testified at today's Senate hearing that, "In the first six months of 2010, the FDA recalled more than 437 million additional products because of high risks, including death... in just six months there were 1.4 medical devices recalled for every person living in the U.S."

Kohl said he would be advocating for further reforms at the FDA and urged Dr. William H. Maisel, Chief Scientist at the FDA's Center for Devices and Radiological Health, to push forward with an effort to classify high-risk devices now defaulting through the agency's "fast track" approval system.
"FDA has had over 20 years to tackle these high risk devices," Kohl said. "As we have seen with the Johnson & Johnson hip implant today, it's high time to protect patient safety and correctly classify these devices."

Kohl also suggested that FDA develop a "more robust post-market surveillance program" signaling his interest in addressing this concern in the Medical Device User Fee and Modernization Act reauthorization next year.

A webcast of the hearing is available on the committee webpage: http://www.aging.senate.gov/

We'd love to heard your comments.

Don

A recent post about recalls and 510(k) - What's missing? (maybe demoninators)

2011-02-18T10:37:00.000-08:00

A recent published article takes the FDA's 510(k) process to task showing that "Most Recalled Medical Devices Went through FDA Fast-Track Process". A finding of the referenced study is stated that "findings reveal critical flaws in the current FDA device review system..."

Perhaps someone should educate the article authors about the concept of demoninators and a smewhat critical flaw in their analysis as well as the actual numbers.

OK, so in the study 113 devices were recalled from 2005 through 2009. 80 of the 113 (70.1%) were cleared via 510(k)s, 12 (10.6%) were approved via PMAs and 8 (0.07%) were not subject to any review. ON the surface these numbers suggest that there are 7 times more recalls of 510(k) cleared devices than for OMA approved devices.

So how many devices were on the market in the US from 2005 to 2009. No telling really, but we can look at the number of devices cleared by FDA in that same time period. FDAs own database shows that there were:

510(k)s cleared   2005-2009  = 15,733 (There were 127,239 510(k)s cleared since 5/28/1976)
PMAs approved 2005-2009 =  ~150 (There were 1,125 PMAs approved since 5/28/1976, with an average of 32 original PMAs per year over the 35 year history)

Numerator    =        80   510(k) devices recalled that were cleared in 2005-2009 divided by
Denominator = 17,733   510(k) devices cleared in 2005-2009 (CDRH only) = ~0.005%

Numerator =   12   PMA devices recalled that were cleared in 2005-2009 divided by
Denominator = 160   PMA devices approved estimated for 2005-2009 (CDRH only) = ~0.075%

By these calculations a device approved by a PMA has approximatley a 15x more likelyhood to have been recalled that a device that was cleared by a 510(k). Demoninators make all the difference.

NOTE = Most denominators will probably be flawed in several respects. Factors such as the follwing come to mind.

Of the devices recalled, were all of them devices that actually were cleared during 2005-2009?

Were the devices that were cleared since May 28, 1976 to 2005 not included? Presumabley they were still beign sold and could have been recalled.

What about the devices that did not have to go through any review process (those on the market before May 28, 1976 and those exempt from any FDA submission)?

Some 510(k)s and PMAs are reviewed by CBER (as opposed to CDRH) and these are not reported here. Were any of the recalled devices CBER reviewed?

etc., etc., etc.

Where is a statistician when you need one?

IMHO
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The article abour the published article.

AboutLawsuits.com

News and Information about Personal Injury Lawsuits

Most Recalled Medical Devices Went through FDA Fast-Track Process: Study

Published: February 18th, 2011

According to new research, 70% of all medical devices recalled since 2005 were approved by the FDA through a controversial “fast-track” process, which only requires the manufacturer to provide minimal data on safety and effectiveness.

The study was published this week in the Archives of Internal Medicine. Researchers found that there were 113 medical devices recalled from 2005 through 2009 that the FDA decided could cause serious injury or death, however only 21 of those medical devices were approved through the agency’s rigorous premarket approval (PMA) process.

The vast majority (80) of the recalled devices were quickly approved through the FDA’s 510(k) process, which only requires that a medical device be “substantially equivalent” to a device that is already on the market. Another 8 devices were not subject to any oversight at all before they were made available to consumers.

The most commonly recalled medical devices were cardiovascular devices, particularly automated external defibrillators (AEDs), which are used to resuscitate patients suffering cardiac arrest. Most of those devices went through the 510(k) process.

Some researchers estimate that as many as 20% of all AEDs have been recalled by the FDA and AED malfunctions have been linked to hundreds of deaths. Last month the FDA announced that it was considering more stringent requirements for external defibrillators due to the high rate of problems.

The 510(k) process has been under fire from outside and within the FDA for years. The expedited process allows medical devices onto the market with virtually no trials for safety and effectiveness if the manufacturer can show they are substantially equivalent to existing medical devices. However, many critics say that the process is too widely used and that the definition of what is substantially equivalent is too vague and often used to approve devices that are radically different from previous medical devices.

Manufacturers are also frequently allowed to model their new devices and fire them through the process based on old devices that were also approved through the 510(k) process; meaning that some medical devices have gone through as many as three or more generations of improvements, changes and alterations without having to go through PMA requirements.

In June 2009, a study by the Government Accountability Office (GAO) found significant shortcomings in FDA medical device approval procedures, and a heavy reliance on the 510(k) process. The GAO report identified gaps in the FDA reviewing process, deficiencies in the agency’s postmarket surveillance, and also found that FDA has not kept up with regular inspections of medical device manufacturing facilities. Many devices which should be put through the more stringent premarket approval process are put through the premarket notification process instead, the GAO found.

This latest study comes less than a month after the FDA announced that it was streamlining the medical device approval process to make it even easier to get some medical devices onto the market. The announcement came as a shock to some experts, who were expecting the FDA to crack down on 510(k) approvals.

“Our findings reveal critical flaws in the current FDA device review system and its implementation that will require either congressional action or major changes in regulatory policy,” the researchers concluded.
In their conclusion, the study’s researchers recommended that the FDA update how it defines “high-risk” medical devices to include the potential of injury when they fail, enforce existing laws that require all “life-saving and life sustaining” medical devices to the PMA process, and expand its inspection of the manufacturing, post-marketing surveillance, performance standards and guidance to devices approved under the 510(k) process.

FDA Items in the President's Proposed FY 2012 Budget

2011-02-18T03:41:00.000-08:00

The President’s FY 2012 Budget Would Create New User Fees, Ban Patent Settlements, and Reduce BPCIA Reference Product Exclusivity

Posted: 15 Feb 2011 10:05 AM PST

By Kurt R. Karst –

The tome that is the President’s Budget for Fiscal Year 2012 is chock-full of new proposals that, if implemented, would significantly affect both brand-name and generic drug manufacturers.

What first caught our attention were some statements in an overview of the proposed FY 2012 budget for the Department of Health and Human Services that:

The Administration will accelerate access to more affordable pharmaceuticals that will lead to cost savings for consumers and health programs across the Federal Government. The President’s Budget includes two proposals to increase availability of generic drugs by providing the Federal Trade Commission [(“FTC”)] authority to stop drug companies from entering into anticompetitive agreements intended to block consumer access to safe and effective generics, and hastening availability of generic biologics while retaining the appropriate incentives for research and development for the innovation of breakthrough products.

Another budget document, titled “Terminations, Reductions, and Savings” provides a little more detail on these proposals. Both of these issues were topics discussed in President Obama’s 2009 10-year budget proposal.

With respect to patent settlement agreements, which opponents refer to as pay-for-delay agreements, the President’s Budget says that “[t]he Administration proposal would give the [FTC] the authority to prohibit pay-for-delay agreements in order to facilitate access to lower-cost generics.” This is authority the FTC has craved for years now, and that according to President Obama’s budget proposal would yield savings of $8,790,000,000 between 2012 and 2021. As we recently reported, in January, Senator Herb Kohl (D-WI), along with several other Senators, introduced S. 27, the Preserve Access to Affordable Generics Act. The bill, like its predecessor versions introduced, amended, and debated in the 111th Congress, would amend the Federal Trade Commission Act to permit the FTC to “initiate a proceeding to enforce the provisions of [new Sec. 28] against the parties to any agreement resolving or settling, on a final or interim basis, a patent infringement claim, in connection with the sale of a drug product.” Such agreements, if challenged, would be presumptively anticompetitive and unlawful unless it can be demonstrated “by clear and convincing evidence that the procompetitive benefits of the agreement outweigh the anticompetitive effects of the agreement.”

With respect to the 12-year period of reference product exclusivity created by the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”), President Obama’s FY 2012 says that:

Under current law, innovator brand biologics have 12 years of exclusivity and broad “evergreening” authority, whereby innovator manufacturers are able to make relatively minor changes to the “potency, purity, and safety” of their products to receive an additional 12 years of exclusivity.

Under the Administration proposal, beginning in 2012, innovator brand biologic manufacturers would have 7 years of exclusivity and would be prohibited from receiving additional exclusivity by “evergreening” their products.

The Obama Administration estimates that the change in reference product exclusivity would yield savings of $2,340,000,000 between 2012 and 2021.

The issue of so-called “evergreening,” which is the practice of obtaining additional periods of exclusivity for product modifications, along with the period of reference product exclusivity were hotly debated during consideration of what ultimately became the BPCIA. According to a December 21, 2010 letter signed by the three principal authors of the BPCIA, evergreening is not a concern because the BPCIA “is clear that no product, under any circumstances, can be granted ‘bonus’ years of data exclusivity for mere improvements on a product.” The letter goes on to note, however, that “if a ‘next generation’ product is approved by the FDA as a new product (significant changes in safety, purity, or potency) then that new biologic will receive its own 12-year period of data exclusivity.”

The President’s FY 2012 Budget (here beginning on page 227, and here beginning on page 437) also proposes the creation of new user fees.

The first new fee is the much-ballyhooed generic drug user fee. Under the President’s proposal, the generic drug user fee charge would be an amount not to exceed $40,122,000 and “would be used to improve review times and reduce the current backlog of applications.” As we recently reported, the ANDA backlog in FDA’s Office of Generic Drugs (“OGD”) continued to grow unabated in 2010, for a grand total of 2,361 original ANDAs pending at the close of 2010, and with an estimated median approval time of 31 months. (According to the latest OGD statistics, the ANDA review backlog dipped slightly in January 2011 to 2,356 original ANDAs; however, the number of ANDAs pending more than 180 days continued to grow, from 1,816 ANDAs to 1,836 ANDAs.)

The President’s FY 2012 Budget would also create a new “reinspection fee for medical products” in an amount not to exceed $14,108,000. According to the proposal, “FDA conducts post-market inspections of manufacturers of human drugs, biologics, animal drugs, and medical devices to assess their compliance with Good Manufacturing Practice and other regulatory requirements. The Budget includes a proposal to enable FDA to assess fees for follow-up reinspections that are required when violations are found during initial inspections.” President Bush made a similar proposal in his FY 2009 budget request.

Finally, the Obama Administration’s budget proposal includes a new “international courier user fee” in an amount not to exceed $5,338,000. According to the budget proposal, “[t]he volume of imports, predominantly medical products, being brought into the United States by international couriers is growing substantially. To ensure the safety of these FDA regulated products through increased surveillance efforts, the Budget includes a new user charge to international couriers.”

Each of the user fee proposals is contingent upon the enactment of authorizing legislation. Generic drug user fees, along with generic drug labeling preemption, may be among the most talked about topics at the GPhA Annual Conference taking place in Orlando later this week.

Comments on the FDA Innovation Pathway

2011-02-18T03:39:00.000-08:00

Nothing New: FDA Announces its Innovation Pathway Program for Breakthrough Technologies

Posted: 14 Feb 2011 10:39 PM PST

By Jeffrey K. Shapiro –

FDA’s Center for Devices and Radiological Health (“CDRH”) has proposed the “Innovation Pathway Program” for breakthrough medical devices. CDRH says it will review these products in 150 days or less, which the agency claims is nearly half the review time of most premarket approval (“PMA”) applications. The first product in the program is from the Defense Advanced Research Projects Agency (“DARPA”). It is a brain-controlled, upper-extremity prosthetic device, which uses a microchip implanted on the surface of the brain to restore near-natural arm, hand, and finger function to patients suffering from spinal cord injury, stroke, or amputation.

Color us skeptical. Not about the DARPA product. We’re talking about the Innovation Pathway Program.

First of all, this program even at its best will affect probably just one or two products each year. In other words, it is a very narrowly focused program.

Second, for many years, CDRH has had an Expedited Review procedure in place to speed approval of “breakthrough technology.” Even CDRH has admitted it has not very worked well.

The Innovation Pathway apparently is intended to improve CDRH’s track record with innovative products. It would work like this: CDRH will issue an Innovation Pathway Memorandum with a proposed roadmap and timeline for the development, clinical assessment, and regulatory review of the device. The product would be assigned a case manager and reviewed by the Center Science Council, which is a new oversight body being developed within CDRH. The Council will consist of senior managers and experienced scientists.

As with the Expedited Review program, enrollment in the Innovation Pathway Program would not change the scientific or regulatory standards that CDRH uses to review submissions and authorize products for marketing.

As we said, color us skeptical. The DARPA brain controlled prosthetic obviously has amazing potential, and FDA likely would have rushed it through in any event. We’ll know if this new program has any value if additional products actually start speeding down the Innovation Pathway.

It already looks like that won’t happen any time soon. CDRH said it will now seek comments from the public on this pathway before it is used again. CDRH will host a public meeting on the Innovation Pathway program on March 15, 2011 at FDA’s White Oak campus.

This public outreach suggests the program announcement has been designed around the single DARPA product, and is not ready for prime time. There will be a delay just to hold a public meeting and then digest the comments and further revise the program.

All of which suggests that it will be quite some time before another product is so lucky as to be allowed to speed down the Innovation Pathway.

We would prefer that CDRH work on significantly reducing the review times for all products, for both innovative and same-old, same-old technology. That would be an innovation CDRH could be proud of.

Digital Pathology Blog

2011-02-11T12:29:00.000-08:00

http://tissuepathology.typepad.com/weblog/

An earlier post

January 25, 2011

Standardization and Validation of Digital Pathology in Clinical Laboratories

The following post was submitted by Dr. Holger Lange, CTO of Flagship Biosciences, who is working with a number of pharmaceutical partners on regulatory companion diagnostics development.

Digital Pathology is a new technology, a new industry, where organizations like CLIA, CAP and the FDA provide limited guidance, and the manufacturers still have to learn what it means to provide instruments into a clinical laboratory.

With Digital Pathology now entering the clinical laboratories, it is crucial for physicians and laboratory professionals to understand the regulatory requirements and how to best implement Digital Pathology in their clinical laboratories.

For the past 4-5 years I have worked for a leading Digital Pathology manufacturer. I was responsible for their first product in the clinical market – a digital IHC workflow solution, and their portfolio of FDA clearances. Now I have put together a presentation that summarizes my experience in the clinical market. I hope it will help many physicians and laboratory professionals to quickly get up to speed on how to deal with the implementation of Digital Pathology in their clinical laboratories.

These are the subjects that are covered in the presentation:

Clinical Laboratory Regulations

A discussion on how the CLIA standard and the CAP checklist apply to Digital Pathology. A review of the new ASCO/CAP guidelines for HER2 and ER/PgR for the latest thoughts on standardization and validation in clinical laboratories.

Medical Device Manufacturer Regulations

An overview of the existing US Food and Drug Administration (FDA) clearances for Digital Pathology with an example of a successful study design. A discussion on the FDA advisory panel meeting on Digital Pathology Whole Slide Imaging (WSI) for the latest thoughts on what it takes to validate Digital Pathology systems for primary diagnosis.

Digital Pathology Systems

Practical tips on how to implement a digital pathology system in a clinical laboratory and how digital pathology manufacturers could make it easier. A demo of how a digital pathology system can help with the logistics of its own validation. A discussion on how going digital could be a game changer for the standardization of pathology, looking at the example of the automatic standardization of staining, using standard controls and automatic image analysis.

Go to the Flagship Biosciences product page for digital pathology regulatory products.

You get an 1½ hour video presentation on a DVD and the presentation transcript.

Save yourself many hours of research and reading! Get the insights you need by viewing this video presentation. Get access to material that cannot be found anywhere else.

FDA approves first 3-D mammography imaging system

2011-02-11T11:57:00.000-08:00

FDA NEWS RELEASE

For Immediate Release: Feb. 11, 2011
Media Inquiries: Erica Jefferson, 301-796-4988, erica.jefferson@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
FDA approves first 3-D mammography imaging system

Selenia Dimensions System may boost accuracy in breast cancer detection, diagnosis

The U.S. Food and Drug Administration today approved the Selenia Dimensions System, the first X-ray mammography device that provides three-dimensional (3-D) images of the breast for breast cancer screening and diagnosis.

A mammogram is a safe, low-dose X-ray of the breast that is the best tool for early detection of breast cancer. However, with the limitations of conventional two-dimensional (2-D) imaging, about 10 percent of women undergo additional testing after the initial screening exam for abnormalities that are later determined to be noncancerous.

The Selenia Dimensions System, an upgrade to Hologic’s existing FDA-approved 2-D system, can provide 2-D and 3-D X-ray images of the breasts. The 3-D images may help physicians more accurately detect and diagnose breast cancer.
“Physicians can now access this unique and innovative 3-D technology that could significantly enhance existing diagnosis and treatment approaches,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health.

The National Cancer Institute recommends women ages 40 and older have a mammogram every one to two years. Nearly 40 million mammograms are performed each year in the United States.

As part of the approval process, the FDA reviewed results from two studies where board-certified radiologists were asked to review 2-D and 3-D images from more than 300 mammography exams. In both studies, radiologists viewing both the 2-D and 3-D images obtained a 7 percent improvement in their ability to distinguish between cancerous and non-cancerous cases as compared to viewing 2-D images alone.

While the combination of the Selenia’s 2-D and 3-D images approximately doubled the radiation dose the patient received, it improved the accuracy with which radiologists detected cancers, decreasing the number of women recalled for a diagnostic workup. There is uncertainty for radiation risk estimates; however, the increase in cancer risk from having both a 2-D and 3-D exam is expected to be less than 1.5 percent compared to the natural cancer incidence, and less than 1 percent compared to the risk from conventional 2-D mammography.

The Mammography Quality Standards Act requires that all health care professionals obtain eight hours of training prior to using new mammography technology on patients. The FDA also requires that the manufacturer provide each facility with a manual clearly defining the tests required for initial, periodic, and yearly quality control measures.

According to the NCI, nearly 200,000 women will be diagnosed with breast cancer this year. And 1 in 8 women will be diagnosed with breast cancer during their lifetime. There is a 98 percent survival rate when breast cancer is detected early and still localized to the breast.

The Selenia Dimensions System is marketed by Bedford, Mass.-based Hologic Inc.

Medical Treatment, Out of Reach - NY Times article

2011-02-11T10:19:00.000-08:00

Received this article by e-mail and am passing it on.

From
Brendan Benner
Vice President of Public Affairs
Medical Device Manufacturers Association (MDMA)

I wanted to make sure you saw the front page story in yesterday’s New York Times' Business section detailing the challenges patients and innovators are having with FDA.

MDMA and others have been working on this story for several weeks, and we believe this story turned out well to show the real-world impact of unnecessary delays.

This is a very compelling piece and has received widespread attention in Congress and Washington media.

I would encourage you to pass this along to the local business and health care reporters in your community to ensure this important topic gets more exposure.

In addition, if your company utilizes social media, this would also be a great item to post and increase its visibility.

All the best,

Brendan

http://www.nytimes.com/2011/02/10/business/10device.html?_r=1&ref=business
Medical Treatment, Out of Reach
By ANDREW POLLACK

Late last year, Biosensors International, a medical device company, shut down its operation in Southern California, which had once housed 90 people, including the company’s top executives and researchers.

The reason, executives say, was that it would take too long to get its new cardiac stent approved by the Food and Drug Administration.

“It’s available all over the world, including Mexico and Canada, but not in the United States,” said the chief executive, Jeffrey B. Jump, an American who runs the company from Switzerland. “We decided, let’s spend our money in China, Brazil, India, Europe.”

Medical device industry executives and investors are complaining vociferously these days that the industry’s competitive edge in the United States and overseas is being jeopardized by a heightened regulatory scrutiny.

The F.D.A., they and others say, appears to be reacting to criticism that its approvals for some products had been lax, leading to a spate of recalls of some unsafe medical devices, like implanted defibrillators and hip replacements.

Now, executives of device companies say the F.D.A. has gone too far in flexing its regulatory muscle, and they worry that a slower, tougher approval process in a weakened economy could chill investments and cripple innovation.

In addition, they say that American patients are being deprived of the latest technology because companies routinely seek approval for new devices in Europe first. For instance, heart valves that can be installed through a catheter instead of open-heart surgery have been available in Europe since 2007 but will not be available in the United States until late this year at the earliest.

“Ten years from now, we’ll all get on planes and fly somewhere to get treated,” said Jonathan MacQuitty, a Silicon Valley venture capitalist with Abingworth Management.

Marti Conger, a business consultant in Benicia, Calif., already has. She went to England in October 2009 to get an implant of a new artificial disk for her spine developed by Spinal Kinetics of Sunnyvale, Calif.

“Sunnyvale is 40 miles south of my house,” said Ms. Conger, who has become an advocate for faster device approvals in the United States. “I had to go to England to get my surgery.”

Stenum Spine Hospital in Germany has performed disk surgery on 1,000 Americans over the last eight years, said Jim Rider, the hospital’s American marketing agent.

Acknowledging industry concerns, the F.D.A. on Tuesday proposed creating an “innovation pathway” aimed at speeding regulatory reviews of a small number of groundbreaking devices. And last month the agency announced measures it said would make the regulatory process more predictable for the vast majority of devices.

“A consistent and predictable review process will stimulate investment here at home and keep jobs from going overseas,” Dr. Jeffery Shuren, the director of the agency’s medical device division, told reporters.

But Dr. Shuren said the F.D.A. would not relax its standards, arguing that Europe’s system might be too lax. He said that a breast implant, a lung sealant and an implant for elbow fractures were approved in Europe but not in the United States, and then had to be taken off the market in Europe for safety reasons.

“We don’t use our people as guinea pigs in the U.S.,” he said

Medical device executives said they welcomed the steps, but continued to express concerns. Consumer advocates, like Dr. Sidney Wolfe of Public Citizen, however, said that device regulation was already much less stringent than for drugs and that the F.D.A. was caving in to industry demands rather than ensuring consumer safety.

Dr. Charles Rosen, a spine surgeon who is also president of the Association for Medical Ethics, said that the newest devices were not always best. He said he had at least 50 patients who had suffered serious problems from an older artificial disk. Many of those patients, he said, had gone to Europe to get them before they were available in the United States.

Just since November, three reports — two sponsored by device industry trade groups and one conducted by the consulting firm PricewaterhouseCoopers — have raised concerns about the F.D.A. approval process. One report found that the rate of recalls in Europe was similar to that in the United States, suggesting faster approvals overseas were not hurting patients.

The complaints are driven in part by financial pressures. Venture capitalists, because of the financial crisis and their own poor returns, have less money and need quicker returns on their investments from the companies they back.

Bigger device companies also complain about the F.D.A., but not as much as struggling start-ups. “The F.D.A. is asking for larger trials, more thoughtful trials, all in the interest of the American public,” said Dr. Stephen N. Oesterle, senior vice president for medicine and technology at Medtronic.

To be sure, the United States remains the clear world leader in medical device innovation, according to the report by PricewaterhouseCoopers. Some 32 of the 46 medical technology companies with annual sales exceeding $1 billion are based in the United States, the report said.

Still, the report said the United States’ lead was slipping.

Device companies have been seeking early approval in Europe for years because it is easier. In Europe, a device must be shown to be safe, while in the United States it must also be shown to be effective in treating a disease or condition. And European approvals are handled by third parties, not a powerful central agency like the F.D.A.

But numerous device executives and venture capitalists said the F.D.A. has tightened regulatory oversight in the last couple of years. Not only does it take longer to get approval but it can take months or years to even begin a clinical trial necessary to gain approval.

Disc Dynamics made seven proposals over three years but could not get clearance from the F.D.A. to conduct a trial of its gel for spine repair, said David Stassen, managing partner of Split Rock Partners, a venture firm that backed the company. “It got to the point where the company just ran out of cash,” Mr. Stassen said. Disc Dynamics was shut down last year after an investment of about $65 million.

Dr. Shuren of the F.D.A. said the agency had concerns from preliminary studies that the material in the gel could cause cancer and that the gel would come out of the disk, requiring a new operation.

Some companies and investors are even contemplating forgoing the American market completely.

“We never intend to spend a nickel in the United States for clinical trials,” said William Starling, a venture capitalist who also runs Synecor, a device company incubator in North Carolina.

Mr. Starling is an investor in Spinal Kinetics, whose artificial disk was implanted in Ms. Conger in England.

The company began working with both the F.D.A. and European regulators in early 2005. It won approval in Europe in 2007 after testing its device in 30 patients and spending $4 million. Since then, thousands of the disks have been implanted.

Only last May did it receive approval for a final trial for F.D.A. approval that would involve about 250 patients. But hard-pressed investors are not willing for now to put up the $50 million or so the trial would cost, Mr. Starling said.

In the meantime, Spinal Kinetics is moving its manufacturing to Germany and has already laid off 20 people in Silicon Valley. One reason for the move, Mr. Starling said, was that some countries in Asia and Latin America allowed use of devices that have been approved in the country in which they are made. So moving manufacturing out of the United States opens up those markets.

Totally forsaking the lucrative American market could be difficult. While approval in Europe is easier, health care systems there tend to spend less on medical devices. Even if a device were approved, doctors in Europe might not use it if there was not enough data proving it really works.

Some companies, however, are trying to generate some sales in Europe in an effort to be acquired by a bigger company, which could then afford to deal with the F.D.A.

Dr. Shuren of the F.D.A. said in an interview that there had been “no conscious effort” to make device approvals tougher. “We are dealing with increasingly more complex devices coming to market,” he said.

But numerous executives say agency reviewers seem to be more cautious as Congress and others criticize the agency for being too lenient. Critics cited two recent examples: the DePuy hip implant recalled last year and an instance in which top agency officials approved a knee repair implant, made by ReGen Biologics, over the strenuous objections of their scientific reviewers.

Pharmaceutical executives are also complaining about how tough the F.D.A. has become. But they are not forsaking the American market, in part because there is not a big disparity in the regulatory system for drugs between the United States and Europe.

Some figures bear out a toughening in devices. The F.D.A. last year granted 19 premarket approvals — the type of clearance required for the most highly regulated devices — down from 48 in 2000.

The average time to win an approval through the less stringent 510(k) pathway, which is used for most devices, rose to 116 days in fiscal year 2008 from 97 days in fiscal year 2002. Agency figures show there have been increases in the proportion of applications sent back for questioning.

Investment by American venture capitalists in the medical device sector has fallen 37 percent since 2007 to $2.3 billion last year, according to the MoneyTree survey from PwC, the National Venture Capital Association and Thomson Reuters. That is steeper than the 27 percent drop for all venture capital investing.

Last year, total venture capital investing increased 19 percent while investment in medical devices fell 9 percent.

--
Brendan Benner
Vice President of Public Affairs
Medical Device Manufacturers Association
1350 I St, Suite 540
Washington, DC 20005
202.354.7172
http://www.medicaldevices.org/

CDRH Seeks Comments on 510(k) Device Process

2011-02-11T10:02:00.001-08:00

GenomeWeb Daily News

CDRH Seeks Comments on 510(k) Device Process

February 11, 2011

By a GenomeWeb staff reporter
NEW YORK (GenomeWeb News) – The US Food and Drug Administration's Center for Devices and Radiological Health is reaching out to industry and the public for input on its plans to change the process for handling 510(k) submissions by collecting public meeting in March.

As GenomeWeb Daily News reported in January, CDRH has issued a 25-point plan aimed at streamlining the review process, clarifying when clinical data should be submitted, and establishing a council of FDA experts to assist applicants in making decisions.

CDRH Director Jeffrey Shuren said at the time that the changes will result in "a smarter medical device program that supports innovation, keeps jobs here at home, and brings important, safe, and effective technologies to patients quickly."

These steps are being considered in order to "strengthen" the review process and to "improve the predictability, consistency, and transparency of its decision-making," CDRH said in a Federal Register posting this week.

"These actions will not only improve the safety of medical devices but also increase the ability of innovating companies to attract investors, estimate costs, and more quickly bring products to market," according to CDRH.

The Center plans to hold is public meeting on March 15 in Silver Spring, Md., at FDA's White Oak Campus.

CDRH is seeking comments on its report in general, as well as in certain areas, such as the eligibility criteria for the new programs; how CDRH should determine what types of technologies will be included in some of these new innovation initiatives; how time frames for the program should work; what criteria should be used for clinical test center certification; how candidates for inter-agency or public-private partnerships will be defined; and other actions CDRH should take to facilitate the development, assessment, and regulatory review of innovative medical devices.

Public Docket for comments on Array-Based Cytogenetic Tests

2011-02-10T05:06:00.000-08:00

Thought it wold be interesting to see the public comments submitted tot he docket for this item. See previous posts where FDA (CDRH) had projected issuing a framework for the validation and review of array CGH assays.

Here is a link to the docket at regulations.gov.

http://www.regulations.gov/#!searchResults;rpp=10;so=DESC;sb=postedDate;po=0;s=FDA-2010-N-0259

There have really only been 2 comments posted from the public.

The College of American Pathologists (http://www.regulations.gov/#!documentDetail;D=FDA-2010-N-0259-0003.1) and
The Cleveland Clinic (http://www.regulations.gov/#!documentDetail;D=FDA-2010-N-0259-0002.1)

The only other items posted are the original Federal Register notice announcing the June 30, 2010 public meeting (http://www.regulations.gov/#!documentDetail;D=FDA-2010-N-0259-0001) and the actual transcript of the public meeting (http://www.regulations.gov/#!documentDetail;D=FDA-2010-N-0259-0004).

Interestingly, FDA does not even seem to have posted the various presentations given at the public meeting to the docket.

Public Docket for FDA/CDRH Medical Device Innovation Initiative

2011-02-10T04:46:00.000-08:00

If you are interested in following the comments posted to the Public Docket (FDA-2011-N-0062) for this FDA activity, here is a direct link.
http://www.regulations.gov/#!searchResults;rpp=10;so=DESC;sb=postedDate;po=0;s=FDA-2011-N-0062

http://www.regulations.gov/#!home

FDA/CDRH's External Expertise Partnerships (EEP) Program

2011-02-10T04:20:00.000-08:00

External Expertise and Partnerships (EEP)

The Center for Devices and Radiological Health (CDRH) regulates a wide array of medical devices. To keep pace with the rapid development of new technology, and to make decisions based on the best scientific information and knowledge available, CDRH routinely collaborates with experts in the academic community, government entities, clinical practice, and industry. External Expertise and Partnerships is located in the Office of the Center Director in CDRH.

EEP's Mission

EEP's mission is to advance public health by acquiring specialized expertise and material resources that support scientific and clinical evaluations conducted in the offices of CDRH. By filling gaps in expertise for a finite period of time, EEP enhances the efficiency and effectiveness of CDRH operations. EEP is the focal point of all CDRH fellowships and interorganizational partnerships. EEP also fosters scientific innovation by helping offices form partnerships with academia, private sector organizations, and government agencies. The consulting and oversight services facilitate project success and ensure that CDRH employees operate within the context of all legal obligations.

Three Components of EEP

EEP is divided into three general components:

The Medical Device Fellowship Program (MDFP)
Partnerships and Technology Transfer
The Critical Path Initiative

The Medical Device Fellowship Program (MDFP)

The Medical Device Fellowship Program began at CDRH in 2003 with the goal of advancing public health by acquiring specialized expertise and material resources for a finite period of time in support of scientific and clinical evaluations conducted in the offices of CDRH. The Fellowship Program addresses how to place external expertise for targeted projects.

Fellows are full-time or part-time Food and Drug Administration (FDA) employees. Qualified individuals, including clinicians, scientists, researchers, academics, and students in appropriate fields, enjoy unique experiences working with world-class scientists, physicians, and engineers, while helping bring innovative technologies to market. There are opportunities to present research results through publications and presentations.

EEP coordinates MDFP fellows and projects, as well as the CDRH fellowship projects for the FDA Commissioner’s Fellowship Program (CFP) and the FDA-NCI Interagency Oncology Task Force (IOTF) Fellowship.

Partnerships and Technology Transfer

Partnership and Technology Transfer refers to the processes involved in facilitating the transfer of expertise, technology, materials, equipment, and intellectual property. The activities in this area include: advising and consulting with appropriate staff and principal investigators (PIs), determining partnership mechanisms, guiding collaborations, developing and executing partnership tools, fostering communication, and providing oversight through the many phases of collaborations. EEP is the contact point for CDRH Technology Transfer and partnership activities.

Technology transfer has been defined by the Federal Laboratory Consortium for Technology Transfer as follows:

“Technology transfer is the process by which existing knowledge, facilities, or capabilities, developed under federal research and development (R&D) funding, are used to fulfill public and private needs.”

This list is a general overview of technology transfer mechanisms that serve as partnership tools:

Confidential Disclosure Agreements (CDAs)

Provide protection against disclosure of proprietary information

Material Transfer Agreements (MTAs)

Are simple agreements between government, academic, or private sector partners (industry or professional societies)
Permit the transfer of disposable equipment, supplies, materials, or proprietary data or information that is trade secret
Involve no interactive collaboration

Cooperative Research and Development Agreements (CRADAs)

Provide mutually beneficial collaboration and cooperation between FDA and government, academic, or private sector partners (industry or professional societies)
Enable collaborator to contribute personnel, equipment, materials, or funds
Enable government to contribute personnel, equipment, or materials, but NOT funds

Grants

Are funding provided from the government or private sector for a specific project by an application process

Interagency Agreements (IAAs), or IAGs

Are formal agreements between FDA and other Federal agencies
Concern transfer of funds, provision of services, loan of staff, or use of property, facilities, or equipment, or exchange of information (costly)

Memorandums of Understanding (MOUs), also known as Memorandums of Agreement (MOAs)

Represent agreement between two or more government, academic, or private sector partners (including nonprofits, professional societies, etc.)
Establish organizational links in Technology Transfer
Are announced by publication in the Federal Register

The Critical Path Initiative

The Critical Path Initiative facilitates a national effort to modernize the scientific process through which a potential human drug, biological product, or medical device is transformed from a discovery or “proof of concept” into a medical product. The initiative was launched in 2004 after the release of a report titled Innovation/Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products. The report highlighted the difficulty and unpredictability of medical product development and called for a concerted effort to modernize the scientific tools (e.g., in vitro tests, computer models, qualified biomarkers, innovative study designs) and harness the potential of bioinformation used to evaluate and predict safety, effectiveness, and manufacturability of candidate medical products.

The Critical Path Initiative holds potential to improve the tools FDA uses to evaluate the safety and efficacy of human and veterinarian products and the safety and nutrition of food and food ingredients. In another area, new bioinformatics approaches could greatly enhance the interoperability of information tracking systems in the healthcare environment for all regulated products (e.g., adverse events reporting). As resources allow, FDA will initiate partnerships to address some of these scientific hurdles. EEP coordinates CDRH's Critical Path projects.

FDA launches Medical Device Innovation Initiative

2011-02-10T04:07:00.000-08:00

FDA NEWS RELEASE

For Immediate Release: Feb. 8, 2011
Media Inquiries: Karen Riley, 301-796-4674, karen.riley@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA launches Medical Device Innovation Initiative
DARPA-funded prosthetic is first test case

Today the U.S. Food and Drug Administration proposed the Innovation
Pathway, a priority review program for new, breakthrough medical devices
and announced the first submission: a brain-controlled, upper-extremity
prosthetic that will serve as a pilot for the program. The FDA also
announced plans to seek further public comment before the Pathway can
be used more broadly.

The new proposed Innovation Pathway program for pioneering medical
devices, highlighted in a report published on the FDA’s website today,
is part of a broader effort underway in the FDA’s Center for Devices and
Radiological Health (CDRH) designed to encourage cutting-edge
technologies among medical device manufacturers.

The initiative will also seek to strengthen the nation’s research
infrastructure for developing breakthrough technologies and advancing
quality regulatory science. Proposed actions include:

• establishing a voluntary, third-party certification program for U.S.
medical device test centers designed to promote rapid improvements
to new technologies during a product’s development and clinical testing
stages;
• creating a publicly-available core curriculum for medical device
development and testing to train the next generation of innovators; and
• using more device experience and data collected outside the United
States.

In addition, CDRH intends to engage in formal horizon scanning –
monitoring medical literature and scientific funding in a systematic way
to predict where technology is heading. CDRH will include public input
in this process to prepare for and respond to transformative innovative
technologies and scientific breakthroughs.

“Each year, millions of American patients benefit from innovative medical
devices that reduce suffering and treat previously untreatable conditions,”
said CDRH Director Jeffrey Shuren, M.D., J.D. “CDRH’s Innovation Initiative
will help accelerate the development of and patient access to innovative
medical devices, which often fulfill unmet public health needs.”

The FDA has accepted its first submission from the Defense Advanced
Research Projects Agency (DARPA) to review a brain-controlled,
upper-extremity prosthetic designed to restore near-natural arm, hand
and finger function to patients suffering from spinal cord injury, stroke
or amputation. The arm system uses a microchip implanted on the
surface of the brain to record neuronal activity and decode the
signals to actuate motor neurons that control the prosthesis. DARPA
and the FDA have signed a Memorandum of Understanding addressing
both the development and review of this project.

The proposed Innovation Pathway program includes the following features:

• products would have to be truly pioneering technologies with the
potential of revolutionizing patient care or health care delivery;
• selected products would receive an Innovation Pathway memorandum
from CDRH containing a proposed roadmap and timeline for device
development, clinical assessment and regulatory review; and
• products would be assigned a case manager, their important scientific
issues would be identified and addressed earlier in the development process,
and they might be able to qualify for flexible clinical trial protocols.

Applications would be reviewed by the Center Science Council, a new
oversight body currently being developed within CDRH comprised of senior
managers and experienced scientists, who would facilitate this device
development and evaluation process. Enrollment in the Innovation Pathway
program would not change the scientific or regulatory standards that
CDRH would use to evaluate device submissions and determine their
appropriateness for marketing.

Because of the transformative nature of the devices that would be eligible
for this pathway, CDRH expects them to generally be approval pathways
intended for either high risk or novel products.

The FDA could conduct premarket reviews of products in the Innovation
Pathway within 150 days, nearly half the time it currently takes the FDA
to review most premarket approval applications.

CDRH has set up a public docket to solicit public comment on the
Innovation Initiative and will host a public meeting on the topic on
March 15, 2011 at the Center’s White Oak campus.

For more information:

CDRH Medical Device Innovation Initiative at
http://www.fda.gov/deviceinnovation

Links from the FDA website

Medical Device Innovation Initiative Documents

Opportunities to Comment on the Medical Device Innovation Initiative

Public Workshop - Center for Devices and Radiological Health's Innovation Initiative, March 15, 2011

Webcast:

Post from Genomics Law Report on DTC Genetic tests

2011-02-10T03:33:00.000-08:00

Genomics Law Report^®

News and analysis from the intersection of genomics, personalized medicine and the law

Update: FDA Taking Another (Public) Look at DTC Genetic Tests

Posted by Dan Vorhaus on February 8, 2011

Direct-to-consumer (DTC) genetic tests are back on the FDA’s public radar screen. A month from today, the agency’s Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee will meet to “discuss and make recommendations on scientific issues concerning [DTC] genetic tests that make medical claims.” Here is the Federal Register notice (pdf).
The two-day meeting, which is open to the public, will investigate the following topics:

The risks and benefits of making clinical genetic tests available for “direct access by a consumer without the involvement of a clinician (i.e., without a prescription).”
The different types of DTC or direct access tests (e.g., carrier screening, risk prediction in healthy persons, pharmacogenetics, etc.) that might “support differences in the regulatory approach.”
The “level and type of scientific evidence appropriate for supporting [DTC] claims, including whether it should be different than” what is required for similar clinical genetic tests (presumably, non-DTC in vitro tests, including laboratory developed tests, or LDTs).

A complete agenda and list of speakers has yet to be published, but the fact that the FDA is singling out DTC genetic tests for specific attention is sure to be a welcome sign to many. In the whirlwind of activity this past summer, DTC genetic test providers were haled before both Congress and the FDA to defend their businesses, even as the FDA simultaneously unveiled plans to regulate all LDT tests. The frenetic pace of activity left industry, the public and, seemingly, the FDA with a number of unanswered questions. Chief among them: does the FDA consider DTC genetic tests to be LDTs, or do the unique issues raised by direct consumer access to these relatively new products merit separate regulatory consideration? This confusion was reflected in the FDA’s two-day public meeting on LDT regulation and in the written public comments submitted over the following months, which saw a disproportionately high number focus primarily or exclusively on DTC genetic tests, despite the fact that those tests comprise only a fraction of the tens of thousands of LDTs the FDA is seeking to regulate. Which is what makes next month’s DTC-only meeting such a good idea. The meeting is a tacit acknowledgement by the FDA that the agency needs to continue to gather data and viewpoints about DTC genetic tests, along with the unique opportunities and challenges they present, separately from its ongoing efforts at LDT regulation. As a recent Nature Biotechnology editorial suggests, it may also mark the start of a shift in the FDA’s attitude toward the regulation of DTC genetic tests, prompted in part by recent direction from President Obama and the White House, to take a closer look at how agency regulations burden small businesses and to demonstrate an “increased flexibility” in reducing those burdens. That’s significant, especially when coupled with the results of a recent study published in the New England Journal of Medicine by researchers from the Scripps Translational Science Institute (pdf). The Scripps study evaluated the responses of over 2,000 DTC genetic test customers (who used Navigenics’ Health Compass product) and found no significant post-test anxiety or other adverse results. While it will take time to assess the full impact of both the Scripps study (which will require, among other things, longitudinal follow-up and independent confirmation) and the Obama Administration’s new regulatory policies, Nature Biotechnology opines that these signs suggest that the FDA’s “stance to the DTC genetics sector has been perhaps too aggressive” thus far. We agree.

Whatever the FDA’s attitude toward DTC genetic tests in the past, the upcoming public meeting is a positive development. By continuing to facilitate public dialogue—the public may submit comments to the agency in writing until February 23 and apply (until February 15) to make an oral presentation at the meeting—the FDA is sending a clear signal that it recognizes it cannot develop an appropriately tailored system of oversight for DTC genetic tests without consulting, directly and repeatedly, the public it seeks to inform and to protect.

One final note on timing. In early January, despite the ongoing legal and regulatory uncertainty and before the Obama Administration unveiled its new business-friendly approach to regulation, we wrote that direct federal regulation of the DTC genetic testing industry in 2011 appeared highly unlikely. As we head into the spring, with the FDA still clearly in information-gathering mode and Washington’s short-term focus on other priorities, including lessening regulatory burdens overall, there is no reason to adjust that prediction. This should come as welcome news for those who have argued that what the DTC genetic industry needs today is greater transparency and better data, not heightened regulation.

Friday, February 4, 2011 Federal Register - FDA items

2011-02-04T03:57:00.001-08:00

Food and Drug Administration

RULES
New Animal Drugs:
	Masitinib ,
	6326–6327 [2011–2519]	[TEXT] [PDF]
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and Approvals:
	Animal Drug User Fees and Fee Waivers and Reductions ,
	6475–6476 [2011–2441]	[TEXT] [PDF]
Meetings:
	Industry Exchange Workshop on Drug and Device Requirements ,
	6477–6478 [2011–2458]	[TEXT] [PDF]
	Town Hall Discussion with Director of Center for Devices and Radiological Health and Other Senior Center Management ,
	6476–6477 [2011–2490]	[TEXT] [PDF]

Thursday, February 3, 2011 Federal Register - FDA items

2011-02-04T03:56:00.000-08:00

Food and Drug Administration

NOTICES
Agency Information Collection Activities; Proposals, Submissions, and Approvals:
	Current Good Manufacturing Practice Regulations for Type A Medicated Articles ,
	6142–6143 [2011–2355]	[TEXT] [PDF]
Draft Guidance for Industry; Availability, etc.:
	Target Animal Safety and Effectiveness Protocol Development and Submission ,
	6143 [2011–2315]	[TEXT] [PDF]
Draft Guidance; Availability, etc.:
	Positron Emission Tomography Drug Applications – Content and Format for New Drug Applications, etc. ,
	6143–6144 [2011–2314]	[TEXT] [PDF]
Meetings:
	Positron Emission Tomography ,
	6144–6146 [2011–2313]	[TEXT] [PDF]

FDA Deadlines and Transparency - NOT

2011-02-02T13:13:00.000-08:00

A few days ago (January 31, 2011) the first targeted deliverable date from the FDA's 2011 Strategic Priorities for CRDH came an went with no deliverable. We anticipated seeing FDA's framework for the validation and review of array CGH assays.

I am reminded of another "deliverable" that remains missing. On July 16, 2009, FDA cleared a 510(k) premarket notification (actually a de novo submission) for Vermillion's OVA1 Test (Intended use: The OVA1™ Test is a qualitative serum test that combines the results of five immunoassays into a single numerical score. It is indicated for women who meet the following criteria: over age 18; ovarian adnexal mass present for which surgery is planned, and not yet referred to an oncologist. The OVA1 Test is an aid to further assess the likelihood that malignancy is present when the physician’s independent clinical and radiological evaluation does not indicate malignancy. The test is not intended as a screening or stand-alone diagnostic assay. Although clearance was granted in July, the detaill were not posted to the FDA website until about a month later (that seems about normal) and the FDA press release about the clearance was issued September 11, 2009 (nearly 3 months later - is that normal?).

Like many of you, I have been under the impression (apparently mistakenly) that part of the process for clearing a de novo 510(k) was the development of a Special Controls guidance document. The Special Controls guidance document was identified in the FDA clearance letter for the Vermillion assay (http://www.accessdata.fda.gov/cdrh_docs/pdf8/K081754.pdf). To date, FDA still has not issued the guidance. When contacted several months ago, the story was that it was "difficult" to issue guidance. I must concur. It seems extremely difficult since now 18 months have passed since the 510(k) was cleared and FDA has not been able to issue a guidance document that should have been completed at the time the 510(k) was cleared.

Today it is Groundhog Day and I suspect we will see a good deal of time, say six more weeks of waiting (apologies to the groundhog) until we see the promised framework. I'm not holding my breath for the MIA guidance document.

Where is the Framework for Validation and Review of Array CGH Applications?

2011-02-01T10:19:00.000-08:00

In its "2011 Strategic Priorities" document for CDRH, FDA projected that by yesterday (January 31, 2011), it would finalize a framework for the validation and review of array CGH applications. Yesterday came and went without any news about the status of the framework. If I was an array manufacturer (or user) I'd be most curious to know what was happening. (Interesting that it was to be finalized before even issued as a draft).

Is it an oops - "We didn't realize it was due" or maybe "the dog ate it" or maybe

"We bit off more than we could chew - it's "coming soon".

So far FDA is 1 due date passed and 0 goals met. 24 more to go.

FDA CBER Office of Cellular, Tissue and Gene Therapies (OCTGT) Online Courses

2011-01-31T07:34:00.000-08:00

Here is where the utility of the internet begins to shine and FDA is taking advantage of what it has to offer.

The following multimedia courses are currently offered online from CBER's Office of Cellual, Tissue and Gene Therapies (OCTGT). You may submit suggestions for future courses to OCTGTLearn@fda.hhs.gov.

Course List

Introduction and Scope of OCTGT
Presenter: Patrick Riggins. Patrick Riggins introduces the Office of Cellular, Tissue and Gene Therapies and provides a scope of what the office does.
IND Basics in OCTGT
Presenter: Patrick Riggins. This presentation looks at the basics of IND submission in OCTGT.
Sponsor Meetings with OCTGT
Presenter: Lori Tull. Lori Tull describes various sponsor meetings with OCTGT.
“361” Human Cells, Tissues, & Cellular and Tissue Based Products
Presenter: Samuel Barone. In this presentation, Samuel Barone describes what HCT/Ps are and how they are regulated.
The Chemistry, Manufacturing and Controls (CMC) Section of a Gene Therapy IND
Presenter: Andrew Byrnes. In this presentation, Andrew Byrnes explains the basics of how to put together the CMC section of a gene therapy IND, particularly for Phase 1 trials.
Advanced Topics: Successful Development of Quality Cell and Gene Therapy Products
Presenter: Denise Gavin. Denise Gavin aims to guide manufacturers toward successful development of quality cell and gene therapy products, in this presentation.
Cellular Therapy Products
Presenter: Keith Wonnacott. Keith Wonnacott discusses information that is needed to prepare an investigational new drug application for a cellular therapy product.
Preclinical Considerations for Products Regulated in OCTGT
Presenter: Allen Wensky. Allen Wensky provides a basic overview of preclinical considerations that make up one of the three key elements of an IND submission.

US FDA CDRH 2011 Strategic Priorities

2011-01-30T07:38:00.000-08:00

Recently FDA published its 2011 Strategic Poriorities document for CDRH. A PDF version of the document is at

http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDRH/CDRHVisionandMission/UCM240367.pdf.

Among the identified goas was one set for January 31, 2011 (tomorrow). FDA indicated its goal was:

By January 31, 2011, finalize a framework for validation and review of array CGH applications.

A Public Meeting was held on June 30, 2010 and a public docket was established which can be viewed at http://www.regulations.gov/#!searchResults;rpp=10;so=DESC;sb=postedDate;po=0;s=FDA-2010-N-0259

It will be interesting to see if tomorrow brings the announcement of the promised framework for validation and review of these tests. I'm sure it will be virewed with great interest by the medical device industry as well as the the laboratory and academic communities. It will surely give our first glimpse into the direction FDA will take concerning the regulatory of laboratory developed tests (LDTs). Will FDA meeting its stated goal?

Slides from January 20, 2011 FDA-Industry IVD Roundtable Meeting

2011-01-29T10:38:00.000-08:00

The meeting presentations are available on the AdvaMed public website at http://www.advamed.org/MemberPortal/Issues/FDA/FDA+Industry.htm

Meeting held onThursday, January 20, 2011 9:00 AM - 4:00 PM
Meeting held at AdvaMed Offices, 701 Pennsylvania Avenue, NW, Suite 800, Washington DC 20004

Agenda
Presentations:

OIVD Update - Gutierrez

IDEs and Clinical Trials - Mansfield

XMRV and Blood Safety - Hewlett

Industry Feedback - Calleja

CLIA Waiver Submissions - Di Tullio

The RAinfoBlog begins

2011-01-28T12:52:00.000-08:00

Today I start this blog as a place to share information of interest to regulatory affairs professionals. I'm not sure where it will go, but initially I will post information that I hear about, items that I become aware of, and items that I find on the internet during my daily travels there. Hopefully these may be of interest to some of you. If I post something, it will at least have been interesting to me in some way. The only criteria I have at this point is that an item relates to the US or xUS regulation of a product in one or more of the following areas:

   pharmaceutical products (Rx and OTC)
   biological products
   medical devices
   in vitro diagnositc products
   clinical laboratory testing
   pharmacogenomics
   personalized medicine
   companion diagnostics
   combination products
   genetic testing (including direct to consumer)
   foods
   recomibinant materials
   cosmetics
   tobacco products
   holistic medicine

As a regulatory professional myself (I have been doing this in the US since 1976), I find the area interesting, at times challenging, even sometimes a little bit absurd where all I can do is shake my head and carry on. It is never dull.

There is a plethora of information readily available on the internet with more added each day, new laws, new regulatons, confusing and conflicting requirements, guidance and advice that do not specify expectations that can be relied upon to not change next month.

To try to make sense of this area and capture it in some way, in 1996 I started several activities to try to spread the gospel concerning available electronic information. In those early days, it was dial up electronic telephone bulletin boards (I ran one) and "fax back" systems including some early efforts by the US Food and Drug administration with these tools, which now seem quaint and somewhat primitive. It has now developed from simple internet websites (the remnants of mine is at http://www.rainfo.com/). I hope to revive it and give it new life soon. Websites have grown more sophisticated as time went by and many nice and useful "web portals" still exist. (How many regulatory professionals do you know that still have a subscription the US Federal Register paper edition? Mine whent by the wayside a long time ago.) Now we are in the area of social media with RSS, Facebook, Twitter, Flickr, and blogs galore. (Apologies to you all for any of the many social media tools I left out.)

I will leave the option turned on for you to post comments to this blog. I hope you will do so in the spirit of sharing things you too find or have found useful.

So here goes. I'm sure it will be an INTERESTING EXPERIENCE. I hope you find it so as well.

Don Kafader

donkafader2@gmail.com

Cary, North Carolina, United States

RAinfo

Back to Blogging

A recent post about recalls and 510(k) - What's missing? (maybe demoninators)

FDA Items in the President's Proposed FY 2012 Budget

FDA Law BlogHyman, Phelps & McNamara, P.C.

Comments on the FDA Innovation Pathway

FDA Law BlogHyman, Phelps & McNamara, P.C.

Digital Pathology Blog

An earlier post

January 25, 2011

Standardization and Validation of Digital Pathology in Clinical Laboratories

FDA approves first 3-D mammography imaging system

FDA NEWS RELEASE

Medical Treatment, Out of Reach - NY Times article

CDRH Seeks Comments on 510(k) Device Process

CDRH Seeks Comments on 510(k) Device Process

Public Docket for comments on Array-Based Cytogenetic Tests

Public Docket for FDA/CDRH Medical Device Innovation Initiative

FDA/CDRH's External Expertise Partnerships (EEP) Program

External Expertise and Partnerships (EEP)

The Medical Device Fellowship Program (MDFP)

Related Links

Confidential Disclosure Agreements (CDAs)

Material Transfer Agreements (MTAs)

Cooperative Research and Development Agreements (CRADAs)

Grants

Interagency Agreements (IAAs), or IAGs

Memorandums of Understanding (MOUs), also known as Memorandums of Agreement (MOAs)

Related Links

Related Links

FDA launches Medical Device Innovation Initiative

FDA NEWS RELEASE

Medical Device Innovation Initiative Documents

Opportunities to Comment on the Medical Device Innovation Initiative

Related Links:

Webcast:

Post from Genomics Law Report on DTC Genetic tests

Friday, February 4, 2011 Federal Register - FDA items

Thursday, February 3, 2011 Federal Register - FDA items

FDA Deadlines and Transparency - NOT

Where is the Framework for Validation and Review of Array CGH Applications?

FDA CBER Office of Cellular, Tissue and Gene Therapies (OCTGT) Online Courses

US FDA CDRH 2011 Strategic Priorities

Slides from January 20, 2011 FDA-Industry IVD Roundtable Meeting

The RAinfoBlog begins

FDA Law Blog
Hyman, Phelps & McNamara, P.C.

FDA Law Blog
Hyman, Phelps & McNamara, P.C.