FDA Shown Approving New Drugs Faster than Europe

(TheDigitalWay, Pixabay)

6 April 2017. An analysis of regulatory actions in the U.S. and Europe, shows the U.S. Food and Drug Administration approves more new therapies and faster than the European Medicines Agency. Results of the analysis by a team from Yale University and other institutions appear in today’s issue of New England Journal of Medicine.

FDA is often cited by opponents of regulation in the U.S. as an agency imposing rules that meddle in or even cripple the work of industry. In his speech to Congress on 28 February, President Trump pointed out in the audience Megan Crowley, a student at Notre Dame University, who suffers from Pompe disease, a rare disorder that confines her to a wheelchair. Trump used her story to take a shot at FDA’s regulations …

But our slow and burdensome approval process at the Food and Drug Administration keeps too many advances, like the one that saved Megan’s life, from reaching those in need. If we slash the restraints, not just at the FDA but across our government, then we will be blessed with far more miracles just like Megan.

Not everyone in the pharmaceutical industry holds that view, however. In an essay shared on the Pharmaceutical Research and Manufacturers of America, or PhRMA web site on 22 March, Jim Robinson, president of drug maker Astellas America, notes that “A state-of-the-art FDA helps shepherd innovations from clinical trials to the patient’s bedside, while incorporating unique approaches to drug development and regulatory decision-making.”

To assess the agency’s track record, a research team led by Joseph Ross, a professor of medicine and public health at Yale University, evaluated FDA’s performance in approving new treatments, and compared that record against its European counterpart, the European Medicines Agency. Ross, with Nicholas Downing of Brigham and Women’s Hospital and Audrey Zhang of New York University, reviewed FDA’s and EMA’s approvals of new therapies between 2011 and 2015. The team then classified the approved treatments by disease type and recorded the length of time each agency needed to review the drugs.

The results show in that 5-year period, FDA approved 170 new therapies, compared to 144 for EMA. The two agencies show similar profiles in the diseases addressed by the new drugs, with about one-third of the treatments for cancer, and 14 to 15 percent each for heart disease or diabetes, and infectious diseases. FDA, however, approves a higher percentage of orphan drugs — those addressing small populations, like Pompe disease — with 44 percent of FDA’s approvals going for these rare diseases, compared to 25 percent of EMA’s approvals.

In addition, FDA approves new therapies faster than EMA. The median amount of time needed for FDA approvals in this period was 306 days compared to 383 days for EMA. Approval times were particularly faster at FDA for cancer, infectious disease, and orphan drugs. Ross and colleagues identified 142 new therapies approved by both FDA and EMA, and in those cases FDA needed a median of 303 days for review, compared to 369 for EMA.

The authors note that the current Prescription Drug User Fee Act that authorizes FDA’s drug review processes expires in October 2017 and its reauthorization is being debated in Congress. “This is more information that should inform upcoming debates,” notes Ross in a Yale University statement. “The FDA is already making decisions quickly and increasing its regulatory speed shouldn’t be our number-one priority.”

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• Report: More Biotech Regulations Needed, and Soon
• FDA Begins Cancer Product Review Center
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• More Device Approvals, Higher Risks in Europe than U.S.

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