Nature Medicine | Spoonful of Medicine

FDA outpaces its global peers at drug reviews

The US Food and Drug Administration is often criticized for taking a plodding approach to drug regulation. But when it comes to approving novel therapeutics, the agency is actually much speedier than its European and Canadian counterparts.

“Many of the criticisms that the FDA has been facing over the past couple years were not based on concrete data,” says Jeff Allen, executive director of Friends of Cancer Research, an advocacy organization based in Washington, DC. “Hopefully this will let people really focus on the challenges facing drug regulation, rather than falling into talking points about approval speed.”

Using publically available records, a team from the Yale University School of Medicinein New Haven, Connecticut compared the review times of all small molecule and biologic drugs approved by the FDA, the European Medicines Agency (EMA) and Health Canada from 2001 through 2010. Reporting online today in the New England Journal of Medicine, the researchers found that, regardless of drug type, orphan designation or priority review status, the FDA cleared new medicines, on average, at least a month faster than the other two agencies (see chart).

“Pretty consistently the FDA was coming out on top,” says Yale medical student Nicholas Downing, who led the work. For example, when considering just the 72 agents approved by all three regulators, the median review time at the FDA was a full three months shorter than at the other agencies—under nine months at the FDA, compared to almost a year at the EMA and Health Canada .

Strength in numbers

The results should help shield the FDA against some recent attacks, especially as Congress gears up to renew the Prescription Drug User Fee Act, which allows the FDA to collect ‘user fees’ from pharmaceutical companies to support the infrastructure needed to provide timely and scientifically thorough reviews. But the findings should come as no surprise to people who have actually considered the hard numbers.

Last year, for instance, Allen and his colleagues examined 35 cancer drugs that were reviewed by the FDA and the EMA between 2003 and 2010, and showed that the median approval time was almost six months faster in the US than in Europe. Before that, a team from what is now known as the Centre for Innovation in Regulatory Science in London compared the regulatory review process between 1997 and 2002 across the US, EU, Canada, Switzerland and Australia; they found that the FDA was routinely at the top of the charts for speed. A March 2012 report from the US Government Accountability Office (GAO) also concluded that the FDA met its performance goals for timely drug reviews in all but one year between 2000 and 2010.

“The idea that the FDA somehow inhibits innovation is just based on false premises,” says Michael Halpern, manager for the Scientific Integrity program at the Union of Concerned Scientists, a nonprofit science advocacy group based in Cambridge, Massachusetts. “The agency is able to effectively balance speed without compromising health and safety in a way that suggests Congress should not view the FDA as an obstacle that needs to be reined in, but they need to give the agency the resources and independence so that it effectively protects people.”

The FDA’s track record on medical devices has not been as exemplary, however. Two years ago, researchers from Stanford University in California put out a damning report that compared regulatory timelines for medical devices in Europe and the US. The authors surveyed more than 200 companies, and found that approvals were about two years slower, on average, at the FDA (31 months) compared to the EMA (7 months) for most devices. Adding insult to injury, a GAO report released earlier this year found that the review times for medical device approvals have been creeping upwards in recent years.

The situation could be turning around, though. According to FDA Commissioner Margaret Hamburg, device approval times started to drop finally in 2011. “For the majority of devices that we review, we are as fast or faster than our European colleagues,” Hamburg told attendees of last month’s TEDMED conference in Washington, DC (as reported by the Device Talk blog).

I hope Hamburg is correct. Now we just need to wait for the hard numbers to back her up.


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