Both pharmaceutical industry and regulatory professionals acknowledge the importance of balancing timely access to new medicines with the need for thorough review of drug safety and efficacy data. A new study, funded by the Pew Charitable Trusts (to be published in the New England Journal of Medicine), reviewed drug approval decisions of the Food and Drug Administration (FDA), the Canadian drug regulator -Health Canada, and the European Medicines Agency (EMA) between 2001 and 2010. Yale and Mayo Clinic researchers studied each regulator’s database of drug approvals to identify novel therapeutics and timing of key regulatory events, thereby allowing regulatory review speed to be calculated. The study found that the FDA approves 80% of all the applications it receives. The median time for novel drug reviews by the FDA was 322 days (10.5 months). That was 45 to 70 days ahead of Europe and Canada, which typically completed their novel drug reviews after 12 and 13 months, respectively. Over the same 10-year time frame, the FDA reviewed 225 novel drug applications, 40 more than Europe and nearly 125 more than Canada. Among novel drugs approved in both the U.S. and Europe, 64% were first approved by the FDA. For novel drugs approved in both the U.S. and Canada, 86% were first approved by the FDA.
Release of study results may be too late to impact upcoming drug user fee Congressional legislation. This legislation will reauthorize user fees the FDA collects from companies that make prescription drugs and medical devices. In return for a 6% increase in user fees, the FDA has already agreed to accelerate novel drug approvals even further. The standing Senate bill (approved by the White House) supports a new user fee for the review of generic drugs and adds provisions that address some challenges of globalization by enhancing the safety of the drug supply chain, increase incentives for the development of new antibiotics, renew and enhance mechanisms to ensure that children’s medicines are appropriately tested and labeled, and that expedite the development and review of certain drugs for treatment of serious or life-threatening diseases and conditions (e.g., by allowing conduct of smaller, shorter clinical trials).