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Study: FDA Approves Drugs Faster Than in Europe, Canada

Pills (USA.gov)

(USA.gov)

Researchers at the Yale University medical school have found that since 2001, the U.S. Food and Drug Administration (FDA) generally approves drug therapies faster and earlier than its counterparts in Canada and Europe. The findings of medical student Nicholas Downing and colleagues appear online in the New England Journal of Medicine.

Downing’s team, under the direction of internal medicine professor Joseph Ross, reviewed drug approval decisions of the FDA, the Canadian drug regulator Health Canada, and the European Medicines Agency (EMA) between 2001 and 2010. The researchers chose the regulatory authorities in Canada and Europe for comparison because they face similar pressures to approve new drugs quickly while ensuring they do not put patients at risk.

“The perception that the FDA is too slow implies that sick patients are waiting unnecessarily for regulators to complete their review of new drug applications,” says Downing.

The research looked into each regulator’s database of drug approvals to identify new or different therapies as well as the timing of key regulatory events, which allowed the speed of regulatory reviews to be calculated. The team found that FDA takes a median total time to review of 322 days, while EMA’s median review time is 366 days, with 393 days for Health Canada.

In addition to the total time required for for review, the Yale researchers examined the agencies that approved drugs first, when companies sought approval in more than one jurisdiction. Among 289 unique new therapies, 190 were approved in both the United States and Europe — either by the EMA or through a process of mutual recognition — 154 in both the United States and Canada, and 137 in both Europe and Canada.

Among the 190 drugs approved in both the United States and Europe, nearly two-thirds (64%) were first approved in the United States, with the products available a median of 96 days earlier in the United States. The same pattern emerges for the 154 drugs approved in the United States and Canada, where an overwhelming majority (86%) were first approved in the United States, and available a median of 355 days earlier in the United States.

The authors caution that the study investigated only the speed of review, not their quality, nor decisions on drug safety or effectiveness. Also, the team focused on new molecular and biologic therapeutics, not reformulations of drugs, generics, or medical devices.

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