Lawmakers call upon FDA to approve Plan BA bipartisan group of 62 U.S. lawmakers are calling on the new acting commissioner of the FDA to allow OTC sales of Barr Pharmaceuticals' Plan B (levonorgestrel).
Although the letter stops short of accusing the FDA of allowing politics to interfere with a ruling on OTC status for emergency contraceptive, it chides officials for ignoring evidence.
"We believe this new delay does not truly reflect valid scientific or regulatory concerns," the lawmakers, including six Republicans and one Independent, wrote in a letter dated Oct. 7. "By further delaying the FDA's decision to expand access to EC (emergency contraception), you are seriously hindering efforts to reduce abortions across the U.S.," lawmakers wrote. The letter also called on acting FDA commissioner Andrew von Eschenbach to approve Plan B "without further delay."
Barr has sought OTC status for Plan B for more than two years.
An FDA advisory panel overwhelmingly supported non-prescription sales of the drug, but early last year the FDA rejected Barr's proposal citing concerns about use among girls under 16. Barr re-filed its bid, proposing OTC sales for only those over 16.