Faster FDA Approval But More Safety Issues

President Trump wants the Food and Drug Administration to approve drugs faster, but researchers at the Yale School of Medicine found that nearly a third of medications that reached the market from 2001 through 2010 had major safety issues years after they became widely available to patients.

 

Seventy-one of these 222 drugs were withdrawn, required a “black box” warning about serious side effects, or warranted a safety announcement about new risks to the public, Yale professor Dr. Joseph Ross and his colleagues reported in JAMA on Tuesday. The study included safety actions through Feb. 28.

 

“While the administration pushes for less regulation and faster approvals, those decisions have consequences,” Ross said. The Yale researchers’ previous studies concluded that the FDA approves drugs faster than its counterpart agency in Europe, and that the majority of pivotal trials used in drug approvals involved fewer than 1,000 patients and lasted six months or less. [...]

 

[Dr. Caleb] Alexander [director of the Johns Hopkins Center for Drug Safety and Effectiveness] commended the researchers, saying their study “underscores the importance of surveillance” after a drug has been launched. This helps researchers find new problems — and new benefits — associated with a drug.

 

“All too often, patients and clinicians mistakenly view FDA approval as [an] indication that a product is fully safe and effective,” he said. “Nothing could be further from the truth. We learn tremendous amounts about a product only once it’s on the market and only after use among a broad population.”[...]

 

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© 2016 by The National Center for Health Research. 

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