STAT Plus: Public Citizen urges FDA to ‘immediately’ withdraw drug for preventing premature birth
As an Oct. 29 regulatory meeting nears to review the Makena treatment for preventing premature births, a consumer advocacy group is urging the Food and Drug Administration to immediately withdraw the controversial drug because it failed a confirmatory study.
In a citizen’s petition being filed with the FDA on Tuesday, Public Citizen pointed to a required followup effectiveness study that was released in March, showing Makena is no better than a placebo in preventing preterm birth or major complications from preterm birth. The advocacy group also argued the agency erred when it endorsed the medicine in 2011 under the accelerated approval program, because data from a Phase 3 study that largely formed the basis for approval was “seriously flawed.”
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