Monday, Aug. 24, 1992
Funding Faster Relief
The gripes are all but constant, and the complainers range from drug-company officials to AIDS activists -- all blaming logjams at the U.S. Food and Drug Administration for long delays in the process of approving and distributing potentially life saving drugs. The current boom in biotechnology research, which is likely to unleash new products at unprecedented rates over the next few years, has only exacerbated the problem. But with its limited staff, the FDA has proceeded just about as fast as is safely possible.
Now a proposal that has won the tentative backing of both the FDA and the pharmaceutical industry could clear the way to quicker drug approvals. The plan, which is scheduled for congressional consideration in September, would allow the FDA to collect $75 million from drug companies in application and other fees each year for the next five years. Each individual application would cost $150,000. With the money, the agency expects to hire 600 additional reviewers and cut its average approval time for the most important drugs from 12 to six months.