As the nation focuses on the health care reform debate, other issues affecting the care we receive and the medicines we take can't be ignored.
Case in point: A shocking admission by the Food and Drug Administration that four New Jersey lawmakers and the agency's own former commissioner unduly influenced how a patch to repair injured knees was approved for use.
The FDA's own probe found that agency managers buckled to "extreme" pressure from lawmakers and overruled scientists who twice rejected the Menaflex device produced by the Hackensack, N.J.-based ReGen Biologics. The scientists said that Menaflex — which costs $3,000 and claims to reinforce damaged knee tissue — provided little, if any, benefit to patients.
The lawmakers, Democrats who received campaign contributions from ReGen, all say their contacts with the FDA were appropriate. The former commissioner, Andre von Eschenbach, said he acted properly.
The report disclosed numerous letters and phone calls from the lawmakers — Sens. Robert Menendez and Frank R. Lautenberg and Reps. Frank Pallone Jr. and Steven R. Rothman — encouraging FDA action on Menaflex. Von Eschenbach held a 90-minute meeting with ReGen executives.
How much pressure these contacts had on the FDA is hard to gauge. But it's clear that agency officials came to believe that important people wanted this medical device on the market — and that's the real problem here.
It's likely that every governmental agency is exposed to political pressure of one sort or another. That's unfortunate, but when it applies to the agency charged with protecting Americans from unsafe or ineffective drugs and medical devices the situation can quickly turn dangerous.
The FDA must be certain that it has procedures in place to make sure its decisions — and decision-makers — are insulated from political influence. It would be far too much to ask, we guess, for politicians to recognize the independence of these agencies.
At least the FDA recognizes that it has a problem — that's always the first step to finding a solution.
By the way, the FDA said it will re-evaluate the decision to approve Menaflex, but currently has no plans to pull it off the market.