FDA Drug Approvals Reach Record Low

January 17, 2008
Angie Drakulich
ePT--the Electronic Newsletter of Pharmaceutical Technology

The US Food and Drug Administration approved 69 new drug applications last year, the second lowest number of approvals in the past decade, according to the Jan. 15 edition of Drug Industry Daily.

Rockville, MD (Jan. 8)-The US Food and Drug Administration approved 69 new drug applications (NDAs) last year, the second lowest number of approvals in the past decade, according to the Jan. 15 edition of Drug Industry Daily. The data, analyzed by the Friedman, Billings, Ramsey Group (FBR), show that the number of NDAs fell 26% from 93 approvals in 2006, and is 17% below the 10-year average of 83.4.

Included in the 69 NDA approvals were applications to expand a marketed drug’s indication or add a new formulation, according to Drug Industry Daily. Also included were two biologics (compared with four in 2006) and 16 new molecular entities (NMEs) such as GlaxoSmithKline’s “Tykerb” (lapatinib) for breast cancer, Merck’s HIV treatment “Istentress” (raltegravir potassium), and Novartis’ hypertension drug “Tekturna” (aliskiren). NME approvals decreased 11% from 2006.

Several media reports have questioned whether the decline in approvals results from the harsh scrutiny that FDA has endured during the past few years. Approvals-to-submissions ratios have varied from 49% in 1987 to 109% in 1996. The 2007 ratio may be less than 60%, the lowest since 1994, according to Drug Industry Daily.

Another possible reason for the drop in drug approvals may have to do with the current weak pipeline of new drugs. Some claim that industry has, for example, shifted its focus to concentrate on finding new uses for drugs currently on the market or altering drugs.

“[Companies] got away from their core mission, which was to bring new medicines and new treatments to market,” Kenneth I. Kaitin, director of the Tufts University Center for the Study of Drug Development in Boston, told Bloomberg News in a Jan. 8 report. Katitin added that this trend is likely to reverse itself in the next year.

FDA has not yet commented on the FBR report nor confirmed the data.