FDA Violating Law by Stalling on Morning-After Pill, Says “Sound Science” Amendment Author
WASHINGTON, DC - The Food and Drug Administration (FDA) is violating the law by delaying its decision on granting over-the-counter (OTC) status for the morning-after pill, says the law’s author. A rider attached to the FY05 Agriculture Appropriations bill prohibits the FDA from actions that run counter to its obligation to make decisions based on sound science, not political or ideological considerations (PDF of legislation - see Sec. 774). However, by extending its timeline and continuing deliberation on whether to grant OTC for the Plan B ® contraceptive, the FDA is ignoring the intent of Congress and the overwhelming recommendation of its own scientific panel.
“The FDA’s stall tactics are in clear violation of the law,” said Maloney. “Last year, they said they objected because they were worried about girls 16 and under. That issue has been taken care of with Barr’s new application, so they’re looking for a new excuse to mask their ideological opposition. They’re ignoring the scientific evidence, and that’s harming women’s health.”
Reps. Carolyn Maloney (NY-14) and Henry Waxman (CA-30) successfully offered the “FDA Sound-Science Amendment,” which was introduced after the FDA denied OTC status for Plan B ®, despite the 23-4 recommendation of its expert panel to the contrary. Barr Pharmacies, the maker of Plan B ®, has since reapplied for OTC status only for women over 16, but the FDA announced late last week that it is delaying its decision on that application.