The agency's new rules would clarify its process on granting "waivers" that allow experts with financial ties to drug firms to serve on approval boards. Under the new rules, experts who had been paid by a pharmaceutical company's marketing department would be barred from serving on advisory committees, but experts with other, less obvious financial ties to drug companies -- such as university grants or paid research -- would still be allowed to serve on such committees.
"There are very few academic experts engaged in research who don't have some ties to the industry," says Dr. Scott Gottlieb, FDA deputy commissioner for medical and scientific affairs.
However, critics of the FDA say there are plenty of medical experts who are free from the taint of drug company money. "The idea that all the bright people in the medical world are working for industry is just not right," says Merrill Goozner, director of the Integrity in Science Project at the Center for Science in the Public Interest.
While the FDA's new rules are supposed to bring transparency to the waiver process, critics argue that there should not be waivers at all, and that medical experts should not have any financial ties to the drug industry -- no matter how small or how far in the past. They say any level of involvement can taint the advisory committee votes that greatly influence drug company stock prices.
Representative Maurce D. Hinchey, D-NY, sponsored legislation last year to bar the FDA from allowing anyone with any industry ties from serving on advisory boards. The legislation passed the House but has yet to pass the Senate.
While the FDA argues that it must allow waivers because ostensibly the most competent experts all have industry ties, critics maintain that the FDA cannot properly supervise such a process, since in the past it has made decisions that favored the interests of drug companies over public safety. FDA critic Mike Adams had this to say: "That the FDA has announced it will slightly reduce the level of corruption it allows in drug decision boards is yet another example of this agency's utter lack of integrity. Allowing the FDA to restructure its blatant conflicts of interests is akin to handing over the asylum keys to the inmates."
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