Two big medical device stories come together in today's news. On the one hand, the Wall Street Journal uncovers evidence that a knee-injury device won FDA approval over the objections of agency scientists after a big-time lobbying campaign. Emails show that the agency knew what it was doing, too: FDA's integrity office edited a letter because an agency lawyer said the deleted language would "document special treatment" for the device's maker.
On the other hand, Congress is trumpeting its efforts to legislate legal recourse for patients injured by FDA-approved medical devices. As you know, the Supreme Court last year ruled that devices cleared under a lengthy FDA approval process shouldn't be subject to state-court liability suits, because of the way the law governing devices was written. Almost immediately after the ruling, Congress pledged to change the law to allow patients the right to sue--and now they've introduced legislation to that effect.
What's the link? Well, the knee-injury device in question--Menaflex, made by ReGen Biologics--wouldn't be affected by the new legislation, because it was approved under FDA's fast-track process, which doesn't require the clinical trials necessary under a full review. (Not to mention the fact that the issue here isn't whether Menaflex is safe; it may be.) But the alleged corruption of the FDA approval process shows a.) that FDA reform is sorely needed; and b.) that making the FDA approval the absolutely final word on safety is, sadly, laughable.
Even Andrew von Eschenbach, the ex-FDA Commissioner who presided over the agency until inauguration day this year, says the fast-track approval process "has gotten out of control" and that medical-device oversight needs to be overhauled. And as you know, some FDA scientists went to President Obama directly to ask for reform. Stay tuned.
- read the WSJ story
- check out the article about Congress