The Food and Drug Administration said Thursday that it would reverse the approval of a patch for injured knees that it granted in 2008 after being unduly pressured by four New Jersey congressmen and its own commissioner. Under the Medical Device Amendments to the Food, Drug, and Cosmetic Act of 1938 (the MDA), medical devices are grouped into three classes based on the potential risk they pose to the public. Class III devices typically "present a potential unreasonable risk of illness or injury," and are therefore supposedly subject to the greatest pre-market approval (PMA) scrutiny by the FDA. I say "supposedly," because there is a loophoe in the MDA large enough to drive a truck load of defective medical devices through. The MDA permits devices that are "substantially equivalent" to pre-existing devices to avoid the PMA process.
That’s where the industry lobbyists, politicians, and partisan FDA commissioner come in. The FDA has released a detailed report from last year that found that the agency’s scientific reviewers had repeatedly and unanimously over many years declared the pain patch, known as Menaflex and manufactured by ReGen Biologics, as unworthy of approval, but that they had been overruled by agency managers after political pressure from four Democrats from New Jersey — Senators Robert Menendez and Frank R. Lautenberg and Representatives Frank Pallone, Jr. and Steven R. Rothman. The report also concluded that Andrew C. Von Eshenbach, M.D., the FDA commissioner at the time, had become inappropriately involved in the decision, and that agency procedures had been bypassed. All four lawmakers made their inquiries about Menaflex after receiving significant campaign contributions from ReGen, which is based in Hackensack, N.J.
The FDA has now taken the unprecendented step of admitting that it approved a drug or medice device mistakenly. The patch is apparently so different from earlier devices that it should have never been approved under the "substantially equivalent" exception and should have been tested more thoroughly, according to the FDA. In the PMA process, ReGen had claimed the patch was similar enough to previously approved devices that Menaflex did not need to be tested thoroughly.
Last year, "a group of unhappy medical officers within the FDA complained to Senator Charles E. Grassley, Republican of Iowa, that the ReGen decision was one of several at the agency in which politics trumped science." That seems to be a common problem with our federal and state governments. Here in Virginia, our Attorney General hopes to bully the University of Virginia into conducting only the type of climate research that supports the AG’s political view of the issue.
Kudos to Robert Smith, M.D. and the other FDA device reviewers who had the guts to go to Senator Grassley and report this corruption of the process. One may not agree with Senator Grassley on all the issues, but it cannot be said that he is afraid to stand up to the big drug company and medical device company interests.