On March 6, 2009 in an article entitled “Political Lobbying Drove FDA Process” the Wall Street Journal chronicled how a medical device manufacturer had its product that is intended to be implanted into patients knees quickly approved because of its lobbying efforts. The medical device had the normal review and investigation short circuited.
Medical devices can get quick approval if the device is similar to a product already on the market. The rational is that the first product went through a vigorous review and had studies backing its efficacy and safety; therefore a second product (a copy cat of sorts) shouldn’t have to go through the vigorous studies and review. This fast-track review is called a 510(k) by the FDA, and is intended to be used only when similar products have already been reviewed and approved. This 510(k) fast-track review saves companies money and speeds products to the market where profits can sooner be realized.
The Wall Street Journal Article reported on how ReGen Biologics Inc. was able to have its Menaflex knee device quickly approved through the 510(k) fast track review even though some within the FDA did not believe that it should qualify for the fast track review process and instead should have had to go through a more vigorous vetting process. According to the article, the head of the FDA, when asked about the 510(k) allowance for this particular product, was quoted as saying “There’s something wrong with how that decision was made.” This provides more evidence that consumers need to be able to pursue claims against manufacturers of faulty medical devices if they are injured. The Government Accountability Office, in January, issued a statement indicating that the FDA is too quick to allow 510(k) approvals. Quite simply, the FDA is incapable of monitoring all of the products they are supposed to oversee.
We have no opinion regarding, and this entry is not a comment on, the safety or efficacy of the ReGen Menaflex device; this entry merely points out that the FDA appears unable to adequately perform its functions and therefore puts American consumers at risk. The only safety net for the American consumer when regulation fails, is the ability to bring a private suit seeking compensation for losses. If manufacturers are allowed to hide behind the laws that give immunity to many FDA approved devices, and obtain approvals perhaps without a full review and proper vetting, our citizens will remain at risk.