Could this be the start of a major shift at the FDA?

Knee Jerks

FDA scientists can be such a pain!

Let’s say your company makes a medical device, but time and again those pesky scientists refuse to recommend approval of the device. So what choice do you have? You do what anyone would do. You go to straight to your congressmen and back up the money truck.

True story…

Absorbing the shock

The company is ReGen Biologics of Hackensack, NJ. The medical device is Menaflex, designed to repair torn meniscus, the substance that provides a sort of shock absorber between knee bones. A meniscus tear is a common sports-related injury that’s usually treated with surgery.

According to a New York Times report, FDA scientific reviewers “repeatedly and unanimously over many years” refused to give an OK to Menaflex. The reason: Too many device failures that prompted follow-up operations.

It must have been galling for ReGen executives. They stand by and watch as dangerous drugs with known fatal side effects get FDA approval, but their device can’t get past those scientific sticklers. Sure, Menaflex doesn’t always work (sometimes causing undue pain, anxiety, expense, and considerable inconvenience for patients), but at least it doesn’t KILL anyone.

Time to flex some influence!

No pressure

The Times reports that two senators and two representatives (all from New Jersey) received a total of about $26,000 from ReGen in 2007.

Dr. Andrew C. von Eschenback, the former FDA commissioner, and other FDA officials soon began hearing from the congressmen who are said to have been persistent in suggesting that Menaflex had been unfairly evaluated.

According to The Wall St. Journal, Dr. Daniel Schultz – head of the FDA medical-devices division – eventually overruled agency scientists and approved Menaflex in 2008.

But Dr. Schultz says he was in no way influenced by ReGen executives, even though he described them to WSJ as adversarial and extremely aggressive.

And former commissioner von Eschenback says he was in no way influenced by steady pressure from the four congressmen.

And the congressmen told the Times that they were in no way influenced by generous ReGen campaign donations.

But a recent report claims they were ALL influenced by either money or political power or aggressive lobbying. And can you guess who drafted that report?

FDA scientists.

Feeling a shift?

According to the Times, the FDA scientists’ report marks three “firsts”:
1) It’s the first time a group of FDA officials publicly questioned a specific approval process
2) It’s the first time FDA officials publicly claimed that politics influenced a regulatory decision
3) It’s the first time FDA officials publicly accused a former commissioner of questionable conduct

I wonder if a year or two from now we might recognize this as the first glimmer of change at the FDA. If there’s ever going to be a genuine shift in the agency’s culture – a shift toward transparency and responsibility to patients – then we we might actually end up saying it started here.

I’m not holding my breath. But I am sending out a few (imaginary) gift baskets to each of those FDA scientists.

Sources:
“F.D.A. Reveals It Fell to a Push by Lawmakers” Gardiner Harris and David M. Halbfinger, New York Times, 9/25/09, nytimes.com
“Political Lobbying Drove FDA Process” Alicia Mundy, The Wall St. Journal, 3/6/09, online.wsj.com