KHN Morning Briefing

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As Push Grows For Ever-Faster Approvals, Report Finds One-Third Of FDA-Cleared Drugs Posed Safety Risks

Problems with 71 of the 222 drugs approved in the first decade of this millennium were discovered after the drugs were approved, according to a new study. Those "safety events" warranted a “black box” warning on side effects or a safety announcement about the dangers.

The Washington Post: New Safety Risks Detected In One-Third Of FDA-Approved Drugs
Almost a third of drugs cleared by the Food and Drug Administration pose safety risks that are identified only after their approval, according to a study published Tuesday. The researchers said the study, which appeared in JAMA, shows the need for ongoing monitoring of new treatments years after they hit the market. “We seem to have decided as a society that we want drugs reviewed faster,” said lead author Joseph Ross, an associate professor of medicine and public health at Yale University. That makes it critically important “that we have a strong system in place to continually evaluate drugs and to communicate new safety concerns quickly and effectively,” he said. (McGinley, 5/9)

Kaiser Health News: Nearly 1 In 3 Recent FDA Drug Approvals Followed By Major Safety Actions
“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 in drug approvals involved fewer than 1,000 patients and lasted six months or less. (Lupkin, 5/9)

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