Beware the Year-to-Year Analysis, It May Not Be the Full Picture


The volatility of the drug approval process is evident in the latest novel drug statistics, which show agency approval for new drugs in 2018 is down 44 percent compared with this time last year.

In 2017, the Food and Drug Administration had cleared 18 novel medicines by April, Bob Kirby, a lead pharmaceutical analyst at Fitch Ratings Inc., wrote in a report published June 6. So far, the agency has cleared 10 novel drugs in the first four months of 2018.

Kirby’s analysis shouldn’t be taken as a sign that the FDA is being less effective. It’s more of a testament to how we should be wary of making huge judgments based on numerical swings in drug approval numbers year to year. Because in the world of drug approvals, volatility is the name of the game.

Take the changes year to year in new medicines the FDA approved in the last few years. The agency approved 22 novel drugs in 2016, compared with 45 in 2015 and 46 in 2017. Does it mean the agency was slacking off in 2016? Not necessarily, Kirby says.

"Over time we will see volatility," he said, "but really as long as the industry keeps investing in research and development and is successful at it, we should see a normalized kind of growth."

And the FDA is all too willing to point out that its ability “to sustain a steady increase in annual approvals is dependent on a steady increase in the number of applications submitted," Sandy Walsh, one of the agency’s press officers for the Office of External Affairs, told me.

Kirby’s analysis comes as drug pricing sits at center stage in a national conversation about the affordability of health care. Faster drug approvals has been a priority for FDA's leader Scott Gottlieb since he took over as commissioner of the agency in May 2017.

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