RANCHO RESORT MAINTANANCE POSITION Construction West-Press Printing Finance and Accounting Charles E. Gillman Company Accounting Specialist Health Care CENTRAL ARIZONA COLLEGE DIRECTOR OF HEALTH INFORMATION MANAGEMENT Administrative & Professional Tucson Urban League CEO/President Sales and Marketing Everready Glass Sales Reps Administrative & Professional Jorgensen Brooks Group Counselor BusinessFDA accepted 19 drugs in '07, fewest it has OK'd since '83Bloomberg News
Tucson, Arizona | Published: 01.10.2008
WASHINGTON — The Food and Drug Administration approved 19 new drugs in 2007, the fewest in 24 years, after drugmakers focused on developing uses for existing products.
The number of new medicines, including those made with novel chemical ingredients and using biotechnology, was three fewer than in 2006.
Last year's approvals were tallied by analyst Ira Loss, and the FDA declined to confirm the numbers.
Such drugmakers as GlaxoSmithKline Plc say the FDA raised its standards for approvals, an assertion the agency denies.
Companies shifted emphasis to altering drugs and seeking more diseases to treat with them, at the expense of developing new products, said Kenneth I. Kaitin, director of the Tufts University Center for the Study of Drug Development in Boston.
"They got away from their core mission, which was to bring new medicines and new treatments to market," Kaitin said.
The companies are getting back to developing new treatments, and the annual approval numbers should increase in coming years, Kaitin said.
Companies also are increasingly developing drugs to treat the cause of diseases rather than common symptoms that were easier to target, said Raymond Woosley, president of the Critical Path Institute in Tucson, which is working with the FDA on revamping the drug approval process.
"If you go after the basic cause of the disease, it's just much more complex" and many such drugs fail during human testing, Woosley said. "A lot of these don't get to the FDA."
Approvals included Glaxo's Tykerb for breast cancer and Novartis AG's Tasigna for leukemia.
The FDA's Web site lists 14 "new molecular entities," or novel chemical treatments, approved through November.
Three more were approved in December, bringing the total to 17, according to Loss, who tracks the FDA for Washington Analysis in Washington, D.C.
In addition, the agency cleared two new treatments last year that use biotechnology, gene-based products derived from living organisms, Loss said.
The combined total of approvals is the lowest since 1983, according to the Tufts drug development center. In that year, 14 new drugs were approved, none of them biotechnology products.
The FDA hasn't tallied the approvals for last year and couldn't confirm the number, agency spokesman Christopher DiFrancesco said.
Novartis, based in Basel, Switzerland, and Glaxo of London each had two new drugs approved in 2007, the most of any companies.
The FDA has faced pressure from members of Congress for more strict oversight of drug safety since Merck & Co. withdrew its painkiller Vioxx in 2004 because of increased heart risks.
The FDA hasn't changed its approval standards, said Janet Woodcock, the agency's deputy commissioner and a liaison board member of C-Path, in an e-mailed response to questions.
The number of marketing applications for novel drugs has declined in recent years, and the agency is better able to detect risks, she said.
Drugmakers experiencing setbacks last year included Paris- based Sanofi-Aventis — which has a drug-development center in Oro Valley — and Novartis.
Sanofi pulled the application for its obesity pill Zimulti after an FDA advisory panel raised questions about risks of suicidal thoughts and depression. Novartis' painkiller Prexige was rejected by the agency.
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