Regulatory Focus™ > News Articles > Researchers: FDA Beats EMA, Health Canada in Drug Approval Times

Researchers: FDA Beats EMA, Health Canada in Drug Approval Times

Posted 20 June 2012 | By Alexander Gaffney, RAC 

A recent study published in the New England Journal of Medicine (NEJM) made a claim that likely made the US Food and Drug Administration (FDA) rather pleased: FDA approved drug products nearly two months faster than its European and Canadian counterparts on average and got products to market first in the majority of cases.

Critics of the research, conducted by Yale University's Joseph Ross, assistant professor of Medicine, and Nicholas Downing, a medical student, were quick to criticize the study as failing to take into account the actual time it takes products to get approved instead of just FDA's own review clock. For instance, while a product may take a total of two years to get approved, FDA might only count one year of time as the review time because it doesn't take into account time the company takes to fix deficiencies noted by the agency.

Now Ross and Downing are firing back at critics the same way they did before: with data, and lots of it. Writing in a guest editorial on Forbes, the duo defended their research and re-crunched their original data to take into account the criticism leveled at them. After including the total review time in their analysis, Ross and Downing said their research "found more proof that the FDA is faster than its peers."

The average time taken by FDA to approve a drug product was 322 days, while the European medicines Agency (EMA) took 366 days and Health Canada (HC) took 409. The data also show FDA to have the lowest floor for drug approvals, potentially allows drugs to be approved much faster than any other regulator. Novartis AG's anti-cancer drug Gleevec, for example, was approved in fewer than 80 days by FDA.

The only downside, said Ross and Downing, was that FDA could also take the longest time to approve products out of all of the regulatory authorities, with some reviews stretching to nearly four years.

The researchers explained while their analysis isn't a pure apples-to-apples comparison, it does seems to dispel a common myth amongst critics of FDA. "Our comparison is complicated by the fact that all three regulators do not behave in the same way, but we would expect that to make the FDA look slower - and it doesn't," wrote Ross and Downing.

This was particularly interesting given the differences in regulatory review styles exhibited by the agencies, noted the duo. EMA approved 96% of all applications during the first review round, while FDA and HC approved just 62% and 69%, respectively, during the first round of review. "You might think that extra requests for statistical analysis, data collection, or even new clinical trials would make the FDA process more time-consuming than that in other countries, but it doesn't," observed the researchers.

"It is important to point out that there is no right review speed or right number of cycles of review," conclude the researchers. "But either way, a tortoise-like pace is not one of the FDA's problems."

Read more:

Forbes - More Proof FDA Is Faster Than Other Regulators

Regulatory Focus - Report: FDA Quicker Than EMA, Health Canada for Drug Approvals

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