PEDIATRICS Vol. 92 No. 4 October 1993, pp. 558
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PLAN TO SPEED APPROVAL OF DRUGS: MAKERS WOULD PAY FEES TO U.S

J. F. L. MD

WASHINGTON, Aug. 10—The Government and the drug industry are near an agreement to require the companies to pay fees that would be used by the Food and Drug Administration to hire 600 new examiners and speed approval of drugs, officials on both sides said today.

The agreement, being worked out by Congressional staff members, is intended to resolve what both the Government and industry have said for the last few years is a catastrophe waiting to happen: the number of drug applications is rapidly increasing, especially because of the boom in biotechnology products, some of which might save lives if they were available. But the F.D.A. has not had enough staff members to keep up.

Advocates of people with AIDS, cancer and rare diseases have all pressed for quicker approval of potentially life-saving drugs, for time can be crucial in treatment.