WASHINGTON — In a highly unusual action, the Food and Drug Administration declared Monday that high doses of certain standard birth control pills are a safe and effective way to prevent pregnancy when used as "morning after" pills following unprotected sex.
The agency released dosing information and brand names as a prescription guide for physicians who choose to dispense the pills for consumer use. The Federal Register notice also said that the FDA will encourage pharmaceutical manufacturers to officially seek approval to include such information on their labels.
Though the agency has the authority to require birth control pill makers to make the information available to their customers, it decided against doing so.
And a spokeswoman for one of the two U.S. manufacturers of the pills said that her firm, still fearing potential lawsuits, will not provide the information.
"The best-kept contraceptive secret is no longer a secret," FDA Commissioner David A. Kessler said in an interview. "We have concluded that the use of certain oral contraceptives for emergency contraception is safe and effective. Physicians, clinics and patients who are interested in using contraceptives for post-coital emergency contraception can use this method knowing this."
The pills, which actually are taken twice--the first time no later than 72 hours after unprotected intercourse and then again 12 hours later--have been used in Europe for years in this fashion. But pill manufacturers here have been reluctant to promote or seek approval for emergency contraception because of political pressures and fear of litigation.
As a result, many U.S. doctors are unaware of which pills work best for this purpose and at what doses.
"This is part of our continuing effort to increase information available to patients and physicians," Kessler said. "We encourage the companies to put this use on the labels, but we are making this information available to the American public because we believe doing so will accomplish the same thing."
To receive government approval for notifying consumers of the pills' emergency use, manufacturers essentially would only be required to file the proper paperwork with the agency. With its action Monday, the FDA in effect was notifying manufacturers that it would approve such a request.
But officials at the Wyeth-Ayerst Laboratories, one of two companies that make the pills, said the firm will not seek approval to market the pills for emergency contraceptive use because it fears that telling its customers of the regimen would make it subject to lawsuits filed by women who used the pills for that purpose and had something go wrong.
"We have no plan to market or label any form of birth control pills for post-coital emergency use," said Audrey Ashby, a company spokeswoman. "We do not support revisions to the labeling.
"We do support the need for American women to have more contraceptive choices, but we see product-liability litigation as an important issue in contraceptive marketing and a significant barrier to contraceptive research," she added.
In the past, she said, such legal actions "have had a chilling effect on contraceptive research."
Officials at the second company, Berlex Laboratories, could not be reached for comment.
Kessler said that the FDA has only twice before taken such action in recommending a so-called "off-label" use of a product. These instances include the use of potassium iodide for post-radiation exposure and the use of the drug acetazolamide to treat altitude sickness.
Studies have shown post-coital use of birth control bills to be about 75% effective in preventing pregnancy. Reproductive experts have predicted that the method could prevent as many as 1.7 million unwanted pregnancies and 800,000 abortions annually.
The process involves taking ordinary oral contraceptives containing both estrogen and progestin. Six brands of the pills, made by the two firms, contain the right combination of hormones to prevent a fertilized egg from implanting in a woman's uterus.
Side effects include nausea and vomiting.
The FDA's action was hailed by reproductive-rights groups and condemned by abortion foes, who vowed to fight such use of the pills.
The National Abortion and Reproductive Rights Action League called the development "a major step forward in reproductive health" that "puts reproductive decisions right where they ought to be--in the hands of women and their families."
League President Kate Michelman said: "The fact that the FDA has lifted the veil of secrecy on emergency contraception enables millions of women to prevent a pregnancy they may not intend."
But Judie Brown, president of the American Life League, assailed the agency's decision and said her organization will continue to try to discourage the use of this regimen.