The FDA and Us

The National Academy of Science’s Institute of Medicine, the Government Accountability Office, and the F.D.A.’s own science board, along with numerous independent groups have raised serious questions over the effectiveness and competence of the Food and Drug Administration. Specifically, these Government agencies have all issued reports concluding as reported in the New York Times “that poor management and scientific inadequacies have made the agency incapable of protecting the country against unsafe drugs, medical devices, and (even) food.”

For the first 86 years of FDA’s existence, from 1906-1992, all of its funding came through the U.S. Treasury. In other words, industry and the public paid their taxes, and FDA got appropriations out of the budget. If the FDA made a mistake, many of which occurred over the years, there would be a congressional hearing. The Agency would be accountable to the public through the legislative branch and explain what went wrong and why.

In 1992, unfortunately, the entire regulatory landscape was changed profoundly as the result of a new law which was passed. The law required that much of the cost expended by the FDA on new drug applications would come directly from industry. In other words, to get a drug or device reviewed, the manufacturer would pay directly to the FDA. To understand how this legislation created a cozy relationship between industry and the Agency that regulates it, see this interesting interview. There it is explained why we are seeing an explosion in class action lawsuits against drug companies, the results of “fast track approvals” and increasing numbers of new drugs and devices being withdrawn from the market.

2 Responses to “The FDA and Us”

  1. admin says:

    Do you suggest that the Government remove itself from one of its prime roles, protecting the public health. Would you disband the CDC too, and turn it over to 50 corporations as well?

  2. ottovr says:

    Mmmm … interesting idea… but seriously, I just proposed restricting the mission of the FDA to what gov’t does best (or is supposed to do best), namely checking & monitoring.

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