FDA Reviews New Drug Applications Faster than European, Canadian Regulators

WASHINGTON—The U.S. Food and Drug Administration (FDA) approves new drugs more quickly than its counterparts in Europe and Canada, according to a new paper, “Regulatory Review of Novel Therapeutics: Comparing FDA, EMA and Health Canada,” published online on May 16 by the New England Journal of Medicine. EMA, the European Medicines Agency, is the European Union's counterpart to the FDA. Health Canada is the agency charged with approving drugs in Canada.

“Our findings contradict recent criticisms that the FDA's new-drug review times have slowed, leaving American companies and patients at a disadvantage,” said the paper's lead author, Joseph Ross, MD, of the Yale University School of Medicine. “In fact, our analysis shows that, compared to the EU and Canada, the FDA reviews new drugs more quickly and that American patients most often have access to new drugs first.”

The FDA's median new drug application total review time was 322 days, compared with 366 days in Europe and 393 in Canada. For drugs approved in both the United States and Europe, 64 percent of medicines reached U.S. patients first, a median of 96 days earlier. For drugs approved by both the FDA and Health Canada, novel pharmaceuticals were approved a median of 355 days earlier in the United States, with nearly 86 percent of medicines first cleared by U.S. regulators.

“When it reviews new drugs, the FDA must strike a careful balance between safety and speed,” said Allan Coukell, director of medical programs for the Pew Health Group, which funded the research. “As we debate where the FDA should improve its performance, this paper indicates that the agency—at least at one key point along the regulatory pathway—is moving faster than its peers.”

These findings will inform Innovate FDA, a new Pew Health Group initiative that will measure the FDA's effectiveness in regulating new drugs and medical devices, as well as develop specific recommendations on how to improve its performance. The paper's authors examined one aspect of FDA oversight of pharmaceutical development—the time between a company's submission of a new drug application and the FDA's final approval. The paper did not examine the time to complete studies required by the FDA or review times for drugs that were not approved.

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The Pew Health Group conducts rigorous research to form pragmatic policies that prevent unnecessary health risks. It is part of the The Pew Charitable Trusts, a nonprofit organization that applies a rigorous, analytical approach to improve public policy, inform the public and stimulate civic life. Learn more at www.pewhealth.org.