Christmas Comes Early for Medical Device Manufacturers, FDA Plays Santa Claus

January 31st, 2011. By Hunter West

It was recently that the US Food and Drug Administration (FDA), the government agency charged with responsibility over drugs and medical devices in this country, is seeking to further streamline the review, and approval of medical devices.

Can you hear the cries of joy in the medical device manufacturing heartland?

Well, not entirely. The FDA is also thinking of creating a new category of devices that would require more data than is currently required for approval. That would make it tougher for medical device manufacturers to get new products to market.

Oh, but according to a report by Reuters appearing January 19^th in The New York Times, the FDA is going to defer that idea for a period of time. Which is a good thing, I guess, because the device industry was worried that such a change would slow the progress of devices to market. Devices that can now take advantage of an increasingly streamlined process.

That process—which the FDA is looking to expand, while deferring any effort that might make it tougher for device manufacturers—holds that if a manufacturer seeks approval for a new product that is substantially similar to an existing product already on the market, it can take advantage of a streamlined approval process requiring less scrutiny and testing.

Naturally, that’s a win for the device manufacturers. One spokesperson for a major manufacturer called the news of an expansion of streamlined approvals, and the deferral of tougher policy a more ‘balanced’ approach that shows the FDA is engaged, listening and concerned.

Yes—but to whom is the FDA really listening? And about whom are they really concerned?

It sounds to me like the FDA’s greatest role is to assist device manufacturers (and drug companies).

Is the FDA not a government agency, whose mandate is to first and foremost represent and protect the health and interests of citizens?

Apparently, the goal here is to impose 25 changes to the device approval process that would include the streamlining of reviews for some lower-risk devices. The Reuters report did not identify what those lower-risk devices were.

However, there have been instances where devices “substantially” similar to devices already on the market—and thus benefitting from a streamlined approval process—have failed, causing grievous health concerns for patients—and sometimes death.

Hip replacement systems, cardiac defibrillators and heart leads come to mind. Yes, these products are substantially similar to products already used and used successfully—and thus can be fast-tracked to market for the benefit of all, according to both theory and policy.

Really? A benefit to all? Do we include patients in that lofty ideal?

According to Dr. Jeffrey Shuren, head of the F.D.A. device unit, the steps will lead to “a smarter medical device program that supports innovation, keeps jobs here at home, and brings important, safe and effective technologies to patients quickly.”

Yes, and patients are having to have revision surgeries after their hip replacements—normally expected to last up to 20 years—have failed after a matter of months.

Can we thank a streamlined process for that? And is expanding, rather than contracting the streamlined process prudent in light of such failures?

The FDA says it will ask for comment from the Institute of Medicine on seven proposals, from which it expects a response sometime this summer. The FDA also says it intends to create an internal council to “assure timely and consistent science-based decision making.”

Yeah, right…

Critics say the streamlined process, as it currently exists, is already too liberal and too widely used, and allows unsafe products to be marketed.

There is ample evidence of this. And yet, the FDA is going to loosen the constraints and give device companies even more rope?

I suppose this should come as no surprise. Here’s why. The FDA’s mandate, as I understand it, was always to protect the rights of the consumer, and to serve as a watchdog to police the activities of Corporate America supplying those products. However, over the years the FDA has not grown in lock step with the medical device and drug industry. The FDA has become the David to Big Pharma and Device’s Goliath. The latter has grown to juggernaut status and keeps getting bigger, while the former is just barely hanging on.

In other words, the inmates are running the prison. And the FDA has just handed them more free passes.

Bloody well good luck to us all…

Tags: FDA, medical devices

This was posted on Monday, January 31st, 2011 at 3:42 pm and is filed under Drugs/Medical . Feel free to respond, or trackback. Read our comments policy.