FDA Approved Only 19 New Medications In 2007

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FDA in 2007 approved 19 new medications, adecrease from 22 in 2006 and the lowest number since 1983, when the agencyapproved 14 new treatments, according to Ira Loss of Washington Analysis, Bloomberg/Arizona Daily Star reports. According to Loss, FDA in2007 approved 17 "new molecular entities" and two biotechnologymedications. FDA spokesperson Christopher DiFrancesco said that the agency hasnot totaled the number of new medications approved in 2007 and could notconfirm the number cited by Loss.

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

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Raymond Woosley -- president of the Critical PathInstitute, whichhas partnered with FDA to improve the prescription drug approval process --attributed the decrease to a shift in focus by pharmaceutical companies to thedevelopment of medications for the causes of diseases, rather than thesymptoms, a process that is "just much more complex." He added thatmany such medications fail in clinical trials and "don't get to theFDA."

Increased Standards?

Some pharmaceutical companies,such as GlaxoSmithKline, attribute the decrease to increased FDAstandards for approval of new medications. However, FDA Deputy CommissionerJanet Woodcock denied the claim and attributed the decrease to fewerapplications for approval of new medications and improved efforts by the agencyto identify safety concerns (Blum, Bloomberg/Arizona Daily Star,1/10).

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

Reprintedwith permission from kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, and sign upfor email delivery at kaisernetwork.org/email . The Kaiser Daily Health PolicyReport is published for kaisernetwork.org, a free service of The Henry J.Kaiser Family Foundation.

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