After a last-minute rush, the FDA topped its previous record for the number of new drugs approved in one year--but just barely. In 1982, the agency approved 28 "new chemical entities" (novel compounds as opposed to reformulations of old products), up from the previous record of 27 in 1981. In 1980, the last year of the Carter administration, the total was 12.
The approval race intensified at the end of the year, with six new chemicals approved in December, more than in any other month. Seven new drugs got the green light in December, 1981. But, according to FDA's rating system, only five of the 28 new compounds got an "A" rating, signifying "important therapeutic gain" in the treatment of conditions ranging from severe acne to herniated discs. Another four were considered to be of "modest therapeutic gain," while 19 were found to be of little or no therapeutic gain over existing drugs.
One of the 28 additions was Eli Lilly's anti-arthritis drug Oraflex, which was approved in April but voluntarily withdrawn in August because of safety concerns. The FDA recently approved a waiver for a limited number of patients.
FDA also said that overall approvals--including new doses, combinations, new firms or new purposes--reached a new high of 116, up from 96 in 1981 and 114 in 1980.
Hayes and Schweiker have sought to provide a more hospitable environment for approving new drugs. But their longer-range goal of overhauling the system has taken far more time than either had originally expected.
The agency is also completing its review of comments on the department's October, 1982, proposal for the system of approving new drugs, and officials say a final version should be out by spring.
Another proposal for revising the procedures for investigating new drugs recently was sent to HHS for review.
"It is our understanding" that Schweiker wants to sign off on the plan before he leaves office, one FDA officials said.