Study shows FDA speedier than EU counterpart in reviewing drugs
- A newly published study found the Food and Drug Administration reviews and approves new drugs on average two months faster than the European Medicines Agency, a data point which goes against political posturing painting the agency as a slow-moving regulatory monolith.
- Between 2011 and 2015, the FDA approved 170 new drugs, 26 more than the EMA, according to the comparison, which was published online in The New England Journal of Medicine on April 6.
- The FDA's median review time spanned 306 days, compared to 383 days for the EMA, driven by speedier consideration of drugs for cancer, hematologic and rare diseases — not surprising results given the FDA's revamp of its oncology division under Richard Padzur.
Congress is currently considering President Donald Trump's nominee to head the FDA, and legislation that authorizes the agency to collect fees as part of its process for reviewing drugs is set to expire this fall. With both issues a high priority for lawmakers, the FDA will be under the spotlight for much of 2017.
Republicans, including President Trump, have frequently railed against onerous regulations that block new medical innovations from reaching the market.
But the FDA's comparative speed in reviewing and approving new drugs suggests a more complicated reality and contradicts what Richard Pazdur described in an Associated Press report as the "urban myth" that other agencies move more quickly than the FDA.
On average, regulatory review by the FDA was 60 days shorter than that of the EMA over the five year period — a result that was similar to the difference seen in a previous review of approvals between 2001 and 2010.
Notably, the median review time at the FDA for cancer and hematologic diseases was only 206 days, compared to 379 days at the EMA.
President Donald Trump has repeatedly said he wants to speed up the drug approval process. His draft budget, which severely cuts back funding for basic scientific research at the National Institutes of Health, mentions a "package of administration actions" aimed at increasing regulatory efficiency and speeding the development of new medical products.
The budget also seeks to double the prescription and generic user fees paid by the industry for review of drug candidates under the Prescription Drug User Fee Act (PDUFA). Current legislation, known as PDUFA V, is up for reauthorization before it expires in October 2017 and Congress is currently considering renewal legislation to run through fiscal year 2022.
As lawmakers debate and mark up the legislation this summer, the FDA's performance will be under the microscope — a backdrop to the process of confirming Trump's pick to head the agency, Dr. Scott Gottlieb.
At the same time, the EMA is facing its own challenges. Currently based in London, the EU drugs regulator will have to relocate as a result of the U.K.'s decision to leave the 28-country bloc. Brexit has already hurt hiring and means the EMA will no longer be able to draw on the contributions of the UK's Medicines and Healthcare Products Regulatory Agency, according to a recent report by Reuters.
- New England Journal of Medicine Study
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