The low rate of approvals for genetically engineered drugsduring 1990 could produce "a monumental bottleneck inapprovals over the next few years," the PharmaceuticalManufacturers Association's president said Wednesday.
Just one of 23 drugs approved by the Food and DrugAdministration last year was produced through geneticengineering, according to a survey released by the PMA. In1989, two of 23 drugs approved by the FDA were geneticallyengineered, according to the PMA.
In 1990, the number of recombinant drugs awaiting FDAreview increased from 10 to 18, said PMA President Gerald J.Mossinghoff. An additional 15 genetically engineered drugs arein the final stage of testing, he said.
The FDA appears, on average, to be moving more quickly ondrug reviews. As computed by the PMA, the average length ofFDA review for drugs approved in 1990 was 27.7 months, theshortest time this decade. The comparable average drugsapproved in 1989 was 32.5 months, the PMA said.
The only gene-spliced drug approved in 1990, Actimmune,made by Genentech Inc. of South San Francisco, Calif., wasreviewed in just 12 months. It is a gamma interferon approvedDec. 20, 1990, for treating chronic granulomatous disease.
The PMA also projects that U.S. pharmaceutical companies willspend $9.2 billion in 1991 on research and development, up13.6 percent from 1990. -- Carol Ezzell
(c) 1997 American Health Consultants. All rights reserved.