Is it too soon for the FDA to call 2011 a good year for drug approvals? Maybe not. CDER director Janet Woodcock claims that new chemical and molecular entity approvals have reached a 20-year high, and that two-thirds of drug applications are reviewed in a timely manner. So far this year 20 drugs have been approved, compared to just 21 in all of 2011. Her remarks were delivered in testimony before a U.S. House of Representatives subcommittee on health.
The drug industry and FDA are indeed having a banner year. So far new treatments have been approved for lupus (Human Genome Sciences's Benlysta), melanoma (Bristol-Myers Squibb's Yervoy), prostate cancer (J&J's Zytiga), hepatitis C (Vertex's Incivek) and blood clot prevention (J&J's Xarelto), to name a few. And in many cases, these new drugs offer a significant improvement over existing treatment options.
When questioned about whether the FDA has made it more difficult to obtain approval for new drugs, Woodcock pointed to the industry's high attrition rate in drug development for low approval volume. A recent Thompson Reuters report found that the number of experimental drugs moving in to Phase III trials plunged 55 percent in 2010. The stats weren't much better in earlier stages either: new Phase I studies dropped by 47 percent and while new Phase II trials fell over 50 percent. That high failure rate partially explains why only 21 new drugs got the green light in 2010--fewer than both 2009 and 2008, when 25 and 24 were approved, respectively.
- check out the report
Special Report: The FDA approvals of 2010