FDA caution, 'research drought' cuts drug approvals

By
Julie Schmit, USA TODAY
March 5, 2008, 5:51 PM ET
2 min read

— -- Federal approvals of new drugs last year sank to the lowest in five years, a drop some industry analysts attribute to more cautious regulators and less innovation by drugmakers.

The Food and Drug Administration last year approved 17 new molecular entities — active ingredients that weren't marketed in the USA before.

The FDA also approved 65 original new drug applications last year, the fewest since 1999, according to data from BioMed Tracker of Sagient Research Systems.

Drug applications include new molecular entities as well as new formulations or new manufacturers of existing drugs. The FDA approved 64% of the applications it decided last year, down from 73% the year before, BioMed data show.

Industry analysts say the FDA is more cautious after drawing criticism in recent years for approving some drugs whose risks were found to outweigh their benefits after they went on the market. Examples include painkillers Vioxx and Bextra. Both are now off the market.

"It appears from the outside that the hurdles have been raised," says Michael Levesque, pharmaceutical analyst at Moody's Investors Service. mco

The FDA may be less likely to approve drugs that lack clear advantages over older treatments and may carry unknown risks, adds Linda Bannister, health care analyst at Edward Jones.

Drugs that hit FDA roadblocks last year included diet drug Acomplia, also known as Zimulti in the USA. While pegged a potential blockbuster by industry analysts, an FDA panel in June recommended against its approval due to concerns it that increases the risk of suicidal thoughts. Sanofi-Aventis sny then withdrew the application.

Potential approvals for depression drug Pristiq and schizophrenia drug Bifeprunox were both delayed after the FDA asked for additional data, Levesque says.

The FDA's standards for approving drugs haven't changed, spokesman Christopher DeFrancesco says. He says the rate of approvals to submissions remained steady at about 80% from 1997 through 2005.

Ira Loss of research firm Washington Analysis says the industry's "research drought" has led to weaker applications, thus fewer approvals. An explosion of drug discoveries started in the late 1980s, peaked in the mid-1990s, then "petered out."