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US FDA Approves New Drugs Faster than Its European or Canadian Counterparts

In the race to introduce new drugs to the market, the United States (US) Food and Drug Administration (FDA) has been criticized for dragging its feet in issuing regulatory approvals.  Yet a recent study in The New England Journal of Medicine indicates that contrary to popular perception, the FDA actually approves new drugs more quickly than its European or Canadian counterparts.

In the US, before pharmaceutical companies can sell new drugs to the public, they must submit an application to the FDA that details the drug’s safety and efficacy.  Officials at the FDA review the application and decide whether or not to approve the drug.  Some drugs must go through multiple rounds of review, with the manufacturer supplying additional information each time to satisfy the FDA’s requirements.

To speed regulatory approval of new drugs, the US Congress enacted the Prescription Drug User Fee Act (PDUFA) in 1992.  The PDUFA authorizes the FDA to collect fees from drug manufacturers for each new application.  The fees help cover the costs needed to speed drug review, including the hiring of additional staff.  Congress must reauthorize PDUFA every 5 years, with the next renewal slated for 2012.

Joseph Ross, M.D., M.H.S., at Yale University, and his colleagues wondered how the length of time of the FDA’s application review for new drugs compares with that required by regulatory agencies in Europe and Canada.  So they compared review times for new drugs among the FDA, the European Medicines Agency (EMA, the primary regulator serving the European Union), and Health Canada (the regulator serving Canada) during the most recent PDUFA periods (2001 to 2010).


  • A total of 510 applications for new drugs were approved from 2001 to 2010: 225 by the FDA, 186 by the EMA, and 99 by Health Canada.  Of these, 289 were unique drugs.
  • The median length of time for completion of the first review was 303 days for applications approved by the FDA, 366 days for those approved by the EMA, and 352 days for those approved by Health Canada.
  • The median total review time (the combined length of all rounds of review required for drug approval) was 322 days for the FDA, 366 days for the EMA, and 393 days for Health Canada.
  • 190 new drugs were approved in both the US and Europe, and 121 (63.7 percent) of these were first approved in the US.  Similarly, 154 drugs were approved in both the US and Canada, of which 132 (85.7 percent) were first approved in the US.

What Does It Mean?

For new drugs approved between 2001 and 2010, the FDA reviewed applications more quickly, on average, than the EMA or Health Canada.  Most of the drugs approved by more than one agency were approved first in the US.  These findings counter recent criticisms of the speed of review by the FDA, since the FDA outpaces its European and Canadian counterparts.

Regulatory agencies have dual responsibilities to ensure patient safety while providing timely access to promising new medicines.  This study examined only the speed of the regulatory review process and did not attempt to compare the quality of regulatory decisions.  Therefore, future studies should examine safety parameters such as label changes or drug withdrawals, which might reflect quality and adequacy of (or oversights and gaps in) FDA’s drug review process.

Another limitation of the study is that the researchers only examined applications that were approved by the regulatory agencies, because information about unapproved applications is not publicly available.  Also, they focused on applications for new drugs, rather than on applications for reformulated drugs, generic drugs, or medical devices.

Lastly, the research did not compare the cost of submission among the different regulatory agencies.  Given that a higher cost of submission may lead to an increased cost of medications, and given the increased cost of medications in the US as compared to Europe or Canada, this should also be investigated.

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The study provides researchers and people with Parkinson’s with a better understanding the drug development process.  For further information about the process and how to help speed new treatments for Parkinson’s in your community, join PDF’s upcoming online course – a component of its Parkinson’s Advocates in Research program - which launches on Thursday, June 7.

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Reference: Downing, N. S., Aminawung, J. A., Shah, N. D., Braunstein, J. B., Krumholz, H M., & Ross, J. S. (2012) Regulatory Review of Novel Therapeutics—Comparison of Three Regulatory Agencies. N. Engl. J. Med., doi:10.1056/NEJMsa1200223

Source Date: Dec 31 1969