Reforming FDA medical device approval

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I don't think the American public would be thrilled with the FDA's device approval system - if they knew more about it. But this week the issue is in the news.

This week, the FDA announced "that it has commissioned the Institute of Medicine (IOM) to study the premarket notification program used to review and clear certain medical devices marketed in the United States.The IOM study will examine the premarket notification program, also called the 510(k) process, for medical devices. While the IOM study is underway, the FDA's Center for Devices and Radiological Health (CDRH) will convene its own internal working group to evaluate and improve the consistency of FDA decision making in the 510(k) process."

The 510(K) process is a gem. It was established about 30 years ago, allowing device makers to get a much easier path to approval if they can only show that their idea is "substantially equivalent" to something already approved by the FDA.

I've choked over news stories that make a big deal over 510(k) approval. Case in point: an NBC story on a "breakthrough" laser hair comb for baldness. Bottom line that NBC missed: it was judged "substantially equivalent" to 10 other products already on the market.

Merrill Goozner has been blogging about this. Yesterday he wrote:

The process has been under fire since its inception. Many of the older devices, approved in earlier era, never received careful reviews by the FDA.

The process has also been prone to political pressure. In a widely reported recent case, Regen Biologics of Hackensack, N.J. used four local Congressmen to pressure then FDA commissioner Andrew von Eschenbach to approve a collagen scaffold used in knee reconstruction under the 510(k) process. Recently fired CDRH director Dan Schultz approved the shift. Sen. Charles Grassley has been investigating the affair.

Meantime, Public Citizen issued a news release stating that the "2008 approval of ReGen Biologics's collagen scaffold device, Menaflex, has confirmed the corruption of FDA procedures Public Citizen always believed was at the root of the case." The statement goes on:

The report documents an unprecedented degree of interference from the company and members of Congress. Moreover, then-FDA Commissioner Andrew von Eschenbach was involved in the approval process in a fashion that departed dramatically from customary FDA practices. And the advisory committee process was undermined to effect the makeup of the advisory committee, the questions posed to advisory committee members and who would make the FDA presentation.

While this report unmasks the massive procedural irregularities in the approval of this device, the device remains on the market and patients continue to be treated with a useless device The report recommends that the approval of the device itself be reconsidered. This would not be a moment too late. The essential fact about this device is that it doesn't work. A gold standard, randomized, controlled trial of the product versus a placebo showed absolutely no clinical benefit from this device.

For this reason, Public Citizen opposed the approval of this device - the only group to do so - and provided testimony to Congress about the device in June in which we highlighted both the procedural and scientific problems with the device.

And today Merrill Goozner writes:

The Food and Drug Administration's decision yesterday to reevaluate last year's politicized decision to approve ReGen Biologic's knee repair device offers an important lesson about health care reform. Until special interest lobbying is removed from every level of the health care decision-making process, all schemes at controlling costs are chimerical.

At first blush the two issues seem unconnected. After all, getting a new product approved at FDA is a regulatory decision based on science. Is it safe? Is it effective? If the answer to those questions is yes, then the drug, device, imaging system, or diagnostic test will get approved by the FDA. Given the "reasonable and necessary" standard for payment policy at the Centers for Medicare and Medicaid Services, FDA approval usually ensures that the new product will be reimbursed for use by the nation's seniors. That CMS decision in turn by and large sets the standard for private insurance companies.

Lobbying takes place at every point along that spectrum. This quote, taken from the New York Times account, says it all:

"We did what people do all the time in Washington: we went to our congressmen, we went to our senators," said Gerald E. Bisbee Jr., chairman and chief executive of ReGen. What he failed to add was that companies use the same approach to getting reimbursed by (the Center for Medicare & Medicaid Services) -- another agency whose decisions ought to be based on science.

I'm thrilled to see these issues finally get more attention.

1 Comment

Since I began a blog last March I have found a number of interesting blogs, including yours, that talk about health and government issues. As a former FDA employee I am very impressed by with the new leadership at FDA. They are taking a decidedly different approach to transparency and making some necessary improvements. Anyway, I appreciate your blog, your comments, and invite you to stop by Carl's Blog on FDA Stuff when you have a chance.


About this Entry

This page contains a single entry by Gary Schwitzer published on September 25, 2009 8:27 AM.

Caveats about early release of incomplete AIDS vaccine info was the previous entry in this blog.

And these guys will vote on health care reform?!? is the next entry in this blog.

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