Over the Counter Morning-After Pill Decision Delayed
Government Delays Decision on Whether to Allow Over-The-Counter Sales of Morning-After Pill
The Associated Press
Jan. 21, 2005 - The government has delayed a decision about whether to allow women to buy the morning-after birth control pill over the counter but hopes to act soon, the manufacturer said Friday.
Backers of the pill have been seeking the federal action, arguing that easy access to the product, sold under the trade name Plan B, would prevent thousands of unwanted pregnancies.
Opponents argue that being able to obtain the product without a prescription could lead women, particularly young teens, to experiment with risky sex.
The Food and Drug Administration rejected the over-the-counter proposal last year, citing lack of information about the effect on teenagers.
The manufacturer, Barr Pharmaceuticals, applied again six months ago, proposing that Plan B be made available without prescription to women 16 and over. A prescription still would be required for anyone under 16.
Hours after the company announced the delay, the Center for Reproductive Rights filed suit against the FDA for failing to approve Plan B for over-the-counter access. The suit, filed in federal court in New York, contended the FDA didn't follow its own procedures or statutory and regulatory mandates when it first denied the application, the center said.
"Half of the 3 million pregnancies in the U.S. are unintended each year," Nancy Northup, the center's president, said in a statement. "By denying women over-the-counter access to a safe and effective drug that would significantly reduce those numbers including pregnancies that end in abortion the FDA is acting unlawfully and ignoring its mandate to advance the public health."
Under federal guidelines, the FDA had aimed to have a decision by Friday. But Barr Pharmaceuticals said in a statement Friday that the FDA told the company it was unable to complete its review by then.
"The company remains optimistic that the agency will approve Plan B for OTC sale," Barr said.
The statement said the FDA indicated that "it is committed to completing its review of the application in the near future."
Neither side argues against the safety or effectiveness of the drug. It's a higher dose of the contraceptive hormones that is found in birth control pills. It prevents ovulation or fertilization and can keep a fertilized egg from implanting into the uterus.