The Food and Drug Administration is ordering an unproven drug intended to prevent premature births off the market
FILE - This image provided by Covis Pharma shows packaging for the company's Makena medication. The Food and Drug Administration on Thursday, April 6, 2023 ordered the immediate market withdrawal of a drug intended to prevent premature births, which has remained available for years despite data showing it doesn't help pregnant women. The decision follows repeated efforts by Swiss drugmaker Covis Pharma to keep Makena on the U.S. market while it conducted additional studies.
The decision by FDA Commissioner Robert Califf and the agency's chief scientist marks the first time the FDA has formally forced the removal of a drug that it initially approved based on promising early data. In all prior cases, drugmakers voluntarily pulled medications after the FDA made clear it intended to order removal.
The FDA expedited Makena's approval in 2011 based on a small study suggesting it reduced rates of premature birth in women who had previously had trouble bringing a pregnancy to term. But results from a 1,700-participant study completed in late 2018 showed the drug neither reduced premature births — as originally thought — nor resulted in healthier outcomes for babies.
The FDA has faced pressure to crack down on unproven drugs cleared under its accelerated approval program, which since the early 1990s has allowed dozens of drugs to launch based on early results.
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