A bipartisan group of 62 U.S. lawmakers have called on the new acting head of the Food and Drug Administration to allow sales of Barr Pharmaceuticals Inc.’s “morning-after” pill without a prescription, according to a letter made public Tuesday.
In a letter to Acting FDA Commissioner Dr. Andrew von Eschenbach, the members of Congress stopped short of accusing the agency of earlier postponing a ruling because of politics, but chided officials for ignoring evidence.
“We believe this new delay does not truly reflect valid scientific or regulatory concerns,” they wrote in a letter dated Oct. 7.
Barr has pursued over-the-counter sales of its emergency contraceptive drug, called Plan B, for more than two years.
The drug contains higher levels of a hormone used in birth control pills and must be taken within 72 hours of sexual intercourse. It was approved as a prescription in 1999.
An FDA advisory panel overwhelmingly supported nonprescription sales, but early last year the FDA rejected Barr’s proposal citing concerns about use among teen-aged girls younger than 16. The drug maker refiled its bid, proposing over-the-counter sales for those 16 and older.
In August, the FDA announced an indefinite delay over the issue. Agency officials said the drug was safe and effective, but that they were unsure how to regulate a restriction based on age.
“We find it contradictory and disconcerting that the FDA’s concerns are a direct result of the agency’s own recommendations last May,” the lawmakers, which included six Republicans and one Independent, wrote.
Religious conservatives and other opponents say easier access to emergency contraceptive will spur promiscuity and sexually transmitted diseases. Supporters, including most doctors and women’s rights groups, say it will prevent unwanted pregnancies and abortions.
“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.,” the lawmakers, said, calling on von Eschenbach to approve Plan B “without further delay.”
