Two new genetically engineered biologics and the firstdiagnostic imaging agent were approved by FDA in 1992, alongwith 23 other new drugs, according to an annual reportreleased Wednesday by the Pharmaceutical ManufacturersAssociation (PMA). The approvals brought to 17 the totalnumber of biotechnology drugs and vaccines (including theimaging agent) cleared by FDA.

As of August 1991, 132 biotechnology drugs had been indevelopment, according to the PMA.

John F. Beary III, senior vice president for science andtechnology at PMA, said the burgeoning biotechnology industryhad flooded FDA's Center for Biologics, Evaluation and Research(CBER).

"The work load for new investigational biologic productsproduced by biotechnology has increased dramatically, fromless than five INDs in 1980 to more than 300 in 1992," KathrynZoon, director of CBER, said in the report.

"We are optimistic that we should see some improvement"because of the center's reorganization and additional revenuesfrom user fees, Beary said. (Gerald Mossinghoff, president ofthe PMA, who has been in contact with the Clinton transitionteam, said he expects the legislation to move through Senateand House appropriations committees by the beginning ofApril.)

The new drug application (NDA) approval rate for 1992 wasthe second highest of the past 10 years; FDA cleared 30 newdrugs in 1985 and again in 1991.

The three biotech products are Chiron Corp.'s Proleukin, thefirst treatment approved for metastatic kidney cancer; BaxterHealthcare Corp.'s Recombinate, for prevention and control ofbleeding in patients with hemophilia A; and Cytogen Corp.'sOncoScint CR/OV, a radioactively tagged monoclonal antibodyfor determining the extent and location of colorectal andovarian cancer.

The overall average approval time for new drugs dropped to29.9 months in 1992 from 30.3 months in 1991, promptingMossinghoff to applaud FDA's efforts to reduce the backlog ofdrugs. But the three biotech products took longer; 41.1 monthsfor Proleukin, 31.3 months for Recombinate, and 39.1 monthsfor OncoScint.

Research and development costs for the pharmaceuticalindustry as a whole are expected to rise 13.5 percent to $12.6billion this year, due to concentration of resources on chronicand degenerative diseases, such as heart disease andAlzheimer's, Mossinghoff said. "Potential treatments for thesediseases typically require longer and more extensive testing."

Nonetheless, Mossinghoff said, the rate of price increases forpharmaceuticals has steadily declined over the past severalyears, from 9.5 percent in 1989, to 7.8 percent in 1991, to 5.2percent last year. Asked if the declines represented efforts bythe industry to ward off calls for mandatory price controls,Judith Shuler, assistant vice president for communications atPMA, said the industry recognizes the need to address theproblem.

-- David C. Holzman Special to BioWorld

(c) 1997 American Health Consultants. All rights reserved.

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