Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Well, we told you 2010 was going to be a big year for the FDA.

While most of us were enjoying holiday treats or making new year’s resolutions, a leading FDA official said the agency was developing new guidelines designed to establish stricter standards for the data received from tests with human subjects used by medical device makers when they seek approval for a new or altered device.

Dr. Jeffrey Shuren, the acting director of the Center for Devices and Radiological Health, told The New York Times recently that the FDA most likely will soon urge device makers to take steps like using more sharply defined targets to measure the success of clinical trials. The agency may also urge producers to more closely follow patients enrolled in such trials to determine whether the targets are met, Shuren told The Times.

That sound you hear is the new drumbeat saying that the FDA hasn’t been tough enough on medical devices in the past, at least according to JAMA and an article published in the American Journal of Therapeutics which suggest the agency has to get stricter to better protect the public.

AdvaMed, the big medical device trade group, is taking a “wait and see” approach, at least publicly.

Or as Janet Trunzo, AdvaMed’s executive vice president, technology and regulatory affairs, told us recently, “FDA has not released any formal proposals or guidance regarding changes to the premarket approval (PMA) process.  When the agency does so, we look forward to reviewing and commenting on them.  In general, we support efforts to better clarify FDA submission requirements and to ensure patients have timely access to life-saving and life-enhancing medical technology.

Trunzo went on: “It is important to note that the FDA’s approval process for Class III devices is the agency’s most stringent.  On average, the agency spends roughly 1,200 hours reviewing each application, and has the authority to demand additional data and to refer the application to an expert panel for review.  To obtain FDA approval through the PMA process, a manufacturer must submit a detailed application that contains full reports of all investigations of the safety and effectiveness of the device; a full statement of the components, ingredients, properties, and principles of operation of the device; a full description of the methods used in the manufacture and processing of the device; information about performance standards of the device; samples of the device; specimens of the proposed labeling for the device; and any other relevant information.

“Clinical trial data is but one piece of the overall approval process for medical devices, as the FDA requires data to determine biocompatibility, mechanical strength testing, among others, which are not available through clinical trials.  American patients have access to life-saving, life-enhancing technology because the FDA carefully balances the risks and benefits of each new device or advancement in a given technology.”

But Dan Walsh, a senior member of PA Consulting Group‘s Life Sciences & Healthcare practice, says there will definitely be tougher standards, and some level of more stringent human clinical trial results.  However, he believes there is room for straightforward 510(k) cleared products that make no substantial claims beyond equivalence to currently marketed products.  Dan specializes in technology strategy and acquisition, medical device product development and improving the effectiveness of commercial launch of new medical technologies.

According to Walsh, another repercussion is that the 510(k) will be more narrowly applied, and there likely will be an extended use of ’510(k) with clinicals’ submissions because these trials have not required the same statistical power or clinical depth (high in placebo or alternative therapy arms, etc.)

“If all products were required to obtain PMA approval with robust clinical trials, it would likely impede innovation and use of new technologies,” Walsh told us.

“Since the FDA has mandates for both protection of the public health and the oversight of launch of new therapies for unmet or underserved needs, an all or nothing approach is not feasible or practical,” he adds. “If all submissions required clinicals, one could add at least six months and many millions of dollars to the development time and cost for a medical device, all other things being equal.”

Kim Egan a partner with DLA Piper in Washington, D.C. and an expert in this arena who sits on the advisory board of Life Sciences Law & Industry Report, a publication for lawyers, business executives, directors of research and regulatory specialists practicing in health care-related life sciences fields, gave us some interesting observations, too:

• This development is not overly surprising given the open letter to President Obama that FDA scientists sent last year alleging corruption in the medical device approval process.  The division head stepped down year as well.  FDA is under strong Congressional pressure to reform.
• This report is based on a review of cardiovascular devices only — we can expect similar reviews of additional therapeutic areas over the coming months.
• Industry will want to take an active role in the comment period that will follow FDA’s issuance of draft guidance on new requirements.
• The impact on industry may be limited to products that require full PMA approval.  Devices that rely on 510(k) approval need not submit clinical data, so providing the predicate device is unaffected by FDA’s review, the bulk of new devices on the market should not be affected by the new guidelines.
• The NY Times article contains an error regarding personal injury lawsuits.  The reason personal injury lawsuits are limited is not because of the Riegel decision — that decision simply upheld existing law that provides federal preemption to medical device manufacturers, particularly on failure to warn claims.  Because Congress has expressly preempted failure to warn claims for medical device manufacturers, such claims cannot proceed on state law theories.  This is unlike the pharmaceutical area, where there is no Congressional preemption of state law.

It’s a fine line between regulations with teeth that protect the public without slowing valuable new medical devices. Just ask John Hanley, an attorney at Steptoe & Johnson in LA. He represents two medical device companies that have been significantly impacted by the highly conservative approach now being taken by the FDA.

“They have both decided to pursue clinical approval outside of the U.S. before continuing to attempt to navigate the very difficult road to approval here in the U.S.,” Hanley said of the two companies who wished to remain anonymous.

“In fact, it is disappointing to note that even where these companies have had multiple years of clinical data from activities outside the U.S., the FDA has not approved their pursuing expedited routes through the FDA approval process,” Hanley adds.  “Unfortunately, the FDA’s recently adopted strict stances have resulted in the American public being denied the benefit of new medical technologies.  Moreover, it is expected that the FDA’s conservatism will eventually lead to less investment in medical device companies domestically and thus, less medical device innovation in the U.S.”

Yes, 2010 is already shaping up to be an interesting year at the FDA.

Don’t touch that dial, we’ll keep you posted as this story moves ahead.