Monday Morning, the electronic business update for the healthcare industry reports that the U.S. Food and Drug Administration approved only 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 less than in 2006. Last year's approvals were tallied by consulting firm Washington Analysis Inc. in Washington D.C. Drugmakers such 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 them with, 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. "If you're putting money into extending the lifecycle of a drug on the market, you're taking away from a drug development program." The companies are getting back to developing new treatments, and the annual approval numbers should increase in coming years, Kaitin said.
The combined total of 2007 approvals is the lowest since 1983, when there were 14 new drugs approved, none of them biotechnology products. The FDA hasn't tallied the approvals for last year and couldn't confirm the number.1
Last year, [2006] according to the FDA's figures, only 16 "new molecular entities" and vaccines and two biotech drugs, known as biologics, won approval for sale. That compares with a peak of 53 drugs in 1996, and lows of 17 in 2002 and 14 in 1983, according to FDA records. 2
1 Monday Morning January 14, Vol.16 / No. 2, MedContent Inc.
2 George E. Jordan, The Star-Ledger, "Where Have All The New Drugs Gone: Industry's Medicine Cabinet Running Empty on Compounds" Wednesday, January 09, 2008.
