Speedy Drug Approvals Have Become the Rule, Not the Exception

Friday, May 1, 2015

Source: The New York Times

Congress has over the past few decades passed a series of special approval pathways for important drugs that treat life-threatening or rare diseases. This week, a new bill introduced in the House could add two more.

You might expect these existing special programs to represent a small fraction of new and unusual drugs. But data from the Food and Drug Administration show that a majority of recent drug development has been in therapies that qualify for at least one of these programs. About a third of recently approved drugs qualify for two or more of five special approval programs.

A great interactive graphic mapping research by Aaron Kesselheim and Jonathan Darrow on the website of the New England Journal of Medicine allows you to slice the data a few different ways. (Our chart was constructed using some data from that analysis, alongside more recent data from the F.D.A.)

Dr. Kesselheim, an associate professor of medicine at Harvard Medical School, said the popularity of the expedited programs could be worrisome; the expedited pathways typically require less evidence of a drug’s efficacy or safety than the standard process. “These pathways were intended for very urgent circumstances of serious life-threatening conditions, or no other reasonable clinical alternatives,” he said. “They were originally intended as the exceptions, but now the exceptions are beginning to swallow the rule.”

View All News »