FDA Approved Only 19 New Medications In 2007

FDA in 2007 approved 19 new medications, a decrease from 22 in 2006 and the lowest number since 1983, when the agency approved 14 new treatments, according to Ira Loss of Washington Analysis

According to Loss, FDA in 2007 approved 17 "new molecular entities" and two biotechnology medications. FDA spokesperson Christopher DiFrancesco said that the agency has not totaled the number of new medications approved in 2007 and could not confirm the number cited by Loss.

Kenneth Kaitlin, director of the Center for the Study of Drug Development at Tufts University, attributed the decrease to a shift in focus by pharmaceutical companies to the development of new uses for medications currently on the market, rather than new treatments. "They got away from their core mission, which was to bring new medicines and new treatments to market," he said. However, Kaitlin said that pharmaceutical companies have resumed efforts to develop new prescription drugs and that the number of new medications approved by FDA should increase in future years.

Raymond Woosley -- president of the Critical Path Institute, which has partnered with FDA to improve the prescription drug approval process -- attributed the decrease to a shift in focus by pharmaceutical companies to the development of medications for the causes of diseases, rather than the symptoms, a process that is "just much more complex." He added that many such medications fail in clinical trials and "don't get to the FDA."

Increased Standards?
Some pharmaceutical companies, such as GlaxoSmithKline, attribute the decrease to increased FDA standards for approval of new medications. However, FDA Deputy Commissioner Janet Woodcock denied the claim and attributed the decrease to fewer applications for approval of new medications and improved efforts by the agency to identify safety concerns (Blum, Bloomberg/Arizona Daily Star, 1/10).

According to the Newark Star-Ledger, the decrease indicates "what company executives and bureaucrats already know: The research pipeline that regularly pumped out billion-dollar drugs like Lipitor and Plavix is running dry as regulators are exacting more demands on drug makers." As a result, "drug makers are pouring money into finding new uses for specialized biotech drugs that may be effective against multiple diseases," rather than for a single condition, the Star-Ledger reports (Jordan, Newark Star-Ledger, 1/9).

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