The more we learn the more screwed it looks
Industry Distortion of the F.D.A.
Twelve years ago, the White House and Congress made an agreement with the pharmaceutical industry that seemed eminently reasonable at the time. The industry would supply substantial sums - reaching $200 million a year at latest count - to help the Food and Drug Administration hire more reviewers to speed the approval process for new drugs that might otherwise be held up solely by administrative logjams. The quid pro quo was that the government had to meet tight deadlines for reviewing drugs and had to keep steady its own financing for new-drug reviews, adjusted for inflation.
That seemed a reasonable way to ensure that the government did not cut back on its own funds and use the industry money to pay for reviewers already on the staff. But as an article by Gardiner Harris in The Times on Monday made clear, this 1992 deal - negotiated under the first President George Bush and updated under President Bill Clinton and again under the current president - has grievously distorted the agency's drug safety programs in unforeseen ways.
The blame lies with successive administrations and Congresses that failed to keep sufficient funds flowing to the F.D.A. for pharmaceutical programs. As a result, the agency has had to cannibalize programs to monitor the safety of drugs after they are on the market to keep up its reviews of new drugs before they are allowed on the market. The shift in emphasis is striking. In 1993, the agency's Center for Drug Evaluation and Research spent 53 percent of its budget on new-drug reviews, with most of the rest used for programs to ensure that drugs already on the market were safe. By last year, 79 percent of the agency's budget went for new-drug reviews.
