When asked why the alternative regimen has not been reviewed by the FDA, an FDA spokeswoman responded in an e-mail, “The Agency reviews applications for changes to approved applications that are submitted by drug manufacturers.” The FDA cannot comment on whether or not it has received an application, added Andrea Fischer of the FDA’s Office of Media Affairs.
When asked to comment on moves by some politicians to restrict medical abortions to the FDA-approved regimen, she wrote, “FDA works to ensure that approved products are appropriately labeled based on data submitted in applications for the drugs’ approvals; this provides health care practitioners with accurate information about the safety and effectiveness data supporting each approval.”*
Dr. Steinauer and Dr. Espey reported having no financial disclosures.
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* This story was updated 1/27/2014