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Study of Safety Issues

About a third of newly approved drugs have safety issues after coming on the market, NPR reports.

A Yale School of Medicine-led team of researchers evaluated 222 novel therapeutics approved by the US Food and Drug Administration between 2001 and 2010. As they reported this week in the Journal of the American Medical Association, there were 123 new postmarket safety events associated with 71 of those therapeutics through February 2017.

The researchers noted that it took a median 4.2 years for these issues to bubble up, which they said underscored the need for continuous safety monitoring of new therapeutics. In addition, they reported that safety concerns were more common among biologic and psychiatric drugs, as well as among drugs that had gained accelerated approval — often using surrogate endpoints — and ones that were approved near the regulatory deadline for approval.

"This [finding on surrogate endpoints] has the greatest relationship to policy today," Yale's Joseph Ross tells NPR. "In the 21st Century Cures Act, there's a push to have the FDA move to further support the use of surrogate markers ... [but] they're more likely to have concerns in the postmarket setting."