FDA Used Incomplete Data To Justify Deregulation of Chemical Abortion Pills, Studies Show

Agency relies on data submitted by drug’s distributors.

WFB:

The Food and Drug Administration relied on incomplete data to reach its determination that it is safe to deregulate chemical abortion pills, according to medical studies.

FDA officials brushed aside concerns that women who obtain chemical abortion pills without an in-person doctor visit might put their health at risk. The agency did so by pointing to its Adverse Event Reporting System, which catalogues deaths and other side effects from abortion drugs like mifepristone. That government database, however, fails to encompass the actual number of serious medical incidents—the FDA does not require emergency rooms to report adverse effects from the drug. Medical studies show that thousands of women annually end up in emergency rooms after taking mifepristone. None of their cases are guaranteed to show up in government data.

The reporting system relies on data submitted by the makers of chemical abortion pills, who in turn gather data from doctors who prescribe the drugs. And a new study published this week shows the FDA reports a fraction of the data it is required to collect. Three board-certified OB-GYNs found that adverse effects reported by Planned Parenthood did not show up in the FDA database. In 2009 and 2010, for example, Planned Parenthood reported 1,530 adverse events in women who received mifepristone. The doctors found the FDA database for that time period only showed 664 complications. more