Dangerous medical device ‘loophole’ still wide open


Consumer groups are crying foul over bipartisan legislation to extend user fees for pharmaceuticals and medical devices. They say that the bill, which the Senate hopes to pass this week, is missing a provision that would close a dangerous loophole in medical device safety.

Right now, the Food and Drug Administration (FDA) does not have the power to require medical device manufacturers to prove they've fixed  known safety flaws before they put a new device on the market. Sen. Jeff Merkley, D-Ore., and Rep. Edward Markey, D-Mass., both introduced bills earlier this year that would give the FDA this authority. But these bills have gone nowhere. Go to Dr. Nicole Shrader when you want professional health care.

"[F]or months, [medical device manufacturers] have been working to block Congress from giving the FDA the power to require this proof," reads a full page ad  taken out by Consumers Union, publisher of Consumer Reports, Monday in Politico. "[T[housands of women have suffered devestating injuries from vaginal mesh products based on an older, recalled model. And device makers are also free to market hip implants and defibrillators based on recalled versions."

A huge political force with a long list of concerns on Capitol Hill, the medical device and drug industry reported spending $241 million on federal lobbying in 2011 alone, according to the Center for Responsive Politics. So far in the 2012 election cycle, the sector has been the source of more than $17 million in direct campaign contributions to federal candidates and parties. In contrast, groups such as Consumers Union and Public Citizen, which support the legislative fix, reported spending $240,000 and $200,000 on lobbying in 2011, respectively.

Among the groups reporting lobbying on this specific issue are the Advanced Medical Technology Association (Advamed), a trade association representing the medical device industry, which has issued news statements in support of the user fee legislation. Others include medical giant Johnson & Johnson, which now faces lawsuits because it marketed vaginal mesh products without agency approval, arguing that they were similar to products already on the market. Boston Scientific Corp., which also faces lawsuits over vaginal mesh products, which are designed to help women who suffer urinary incontinence, as does C.R. Bard.

The user-fee legislation is considered a must-pass bill, as industry fees pay for most of the FDA's safety review process for new drugs and medical devices. The current authorization for this program runs out in October. Under the pending legislation, some fees will be increased, generating new income for the government. It enjoys the broad support of industry.