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Nicholas Downing ’14MD:
when FDA says yes to drugs

Nick Downing ’14MD hasn't graduated yet from the Yale School of Medicine. But you might want to heed his pharmaceutical advice: "Not all drug approvals are created equal."

The federal Food and Drug Administration okays some medications based on “several high-quality clinical trials," Downing says in a phone interview. But others win approval with only "preliminary evidence."

That's the conclusion of a study on which Downing is first author, published this week in the Journal of the American Medical Association.

Manufacturers must persuade the FDA that their drugs are “safe and effective.” To understand what that means in practice, Downing and his coauthors systematically reviewed all FDA approvals of new drugs from 2005 to 2012.

They found “significant variation in the quantity and quality" of evidence, with one-third of all new drugs approved on the basis of a single clinical trial.

Many of those were cancer drugs, where quick approval “certainly makes sense given the unmet medical need” for new, effective treatments. But, Downing argues, “if we’re approving some drugs on the basis of preliminary evidence, we need to follow up to make sure the drugs have the benefit we think they will."

He sees that as the biggest implication of the JAMA study. The second biggest: “It’s important for patients and doctors to be aware that not all approvals are created equal”—even though the FDA has allowed a drug onto the market, they still "need to ask questions" about how well it's known to work.

In 2012, Downing cowrote a paper in the New England Journal of Medicine comparing drug approval times in the US, Europe, and Canada. (The FDA is quickest.) That study landed him on Forbes' recent "30 Under 30" list of emerging young leaders in science and healthcare.

Filed under Nicholas Downing, School of Medicine, FDA
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