FDA Approves 35 Novel Medicines in Fiscal Year 2011

At a press conference held Nov. 10, 2011, FDA Commissioner Margaret Hamburg said the agency had approved 35 novel medicines in fiscal year 2011. Among the approved products were two drugs for late-stage metastatic melanoma and the first drug to treat Hodgkins lymphoma in 30 years. Other approvals included drugs to treat late-stage prostate cancer, thyroid cancer, metastatic breast cancer, and late-stage lung cancer.

Hamburg highlighted the agency’s efforts to bring new drugs to market quickly and efficiently while maintaining high standards for drug safety and effectiveness. “FDA approved nearly 70% of these 35 new drugs before any other regulatory agency in the world,” she said. Of the 23 cancer drugs approved between 2003 and 2010 by FDA and the European Medicines Agency, all 23 were approved first in the US, said Hamburg, citing a study published in Health Affairs.

FDA has expanded its drug-approval pathways to include Fast Track, Accelerated Approval, Priority Review, and Expanded Access programs, which are designed to speed the testing, availability, and approval of drugs in various ways. Almost half of the 35 new drugs approved in fiscal year 2011 were approved under priority review, said Hamburg. Under this program, FDA aims to complete its review of safety and effectiveness in six months.

The agency also has shown flexibility regarding clinical trials. Clinical requirements for many of the newly approved drugs were streamlined to permit smaller, shorter, or fewer studies than previous studies. FDA approved several drugs on the basis of single-arm studies or studies with extremely small patient populations, Hamburg said.

FDA’s efforts to modernize its regulatory pathways depend on its initiatives to strengthen regulatory science, said Hamburg. The agency’s Advancing Regulatory Science Initiative currently seeks to identify opportunities to invest in regulatory science. Last year, FDA and the National Institutes of Health launched a Regulatory Science Initiative to encourage research in this field. The agency also established several Centers of Excellence in Regulatory Science, including sites at Georgetown University and at the University of Maryland.