Is the FDA Dominated by Congress?

With two recent mishaps, one wonders if the FDA is actually under the thumb of Congress. Many speculate that the FDA recently failed its duty to protect American citizens and ignored safety concerns about Merck’s very popular painkiller, Vioxx. In the case of Vioxx, David Graham, an FDA reviewer, warned that the risks posed by Vioxx were so high that patients should not use the drug. The study found that Vioxx causing roughly 27,785 deaths from 1999 to 2003. In his Senate testimony, Graham said that senior bureaucrats pressured him to soften those conclusions. He went on to say, "The FDA as currently configured is incapable of protecting America, [and raising safety concerns within the agency is] extremely difficult.” His entire testimony can be found here. Since the FDA approves a drug in the first place and then takes regulatory action against it post-marketing, there is an inherent conflict of interest. The Office of Drug Safety has no regulatory power and therefore must convince the new drug reviewing division that a problem exists before anything beneficial to the public can be done. One of the FDA’s own reviewers as well as outside scientists brought up the dangerousness of this drug, but the FDA called the reviewer a maverick who did not follow agency protocol. Lester Crawford, the Senior Bureaucrat, said “ the FDA's well-documented and long-standing commitment to openness and transparency in its review of marketed drugs” should be taken into consideration. The FDA initiated reviews of Vioxx after it hit the market, evidence [that] the system is working.” Crawford’s only rebuttal to the Senate’s questioning comes far short of an explanation of what the FDA does with taxpayer money. Did the agency ignore risks, then intimidated its own reviewers when they pointed to safety concerns? Merck’s study found an increased risk of heart attack and stroke while taking Vioxx for 18 months. How did the FDA allow a drug on the market that had not been tested for more than 18 months? Is this bureaucratic agency under Crawford’s command acting with impunity? After the hearing, Sen. Chuck Grassley, R-Iowa, said, “ A picture is emerging of an agency that can't see the forest for the trees. Merck knew it had trouble on its hands and took action. At the same time, instead of acting as a public watchdog, the Food and Drug Administration was busy challenging its own expert.” His complete testimony can be found here I sincerely hope that soon some agency will be created to test drugs after the FDA to ensure that nothing slips through the cracks. Such an agency should have equal power to that of the FDA, and maybe they should share the same budget as to add even more accountability to the FDA. More on this here