US OKs wider access for Barr 'morning-after' pill
WASHINGTON, Aug 24: Adult women can buy a ''morning-after'' contraceptive without a prescription, US health officials said yesterday after a three-year political battle over wider access.
Barr Pharmaceuticals Inc.'s Plan B must stay behind pharmacy counters, the Food and Drug Administration said. Women must show proof they are at least 18 to buy the emergency contraceptive pills without a prescription, and younger girls still need a doctor's order.
''When used as directed, Plan B effectively and safely prevents pregnancy,'' the FDA said in a statement.
Backers and opponents had fiercely lobbied the agency with arguments about Plan B's impact on abortion rates and teen sex, and the feud stalled the nominations of two FDA commissioners.
Two Plan B pills can prevent pregnancy when taken within 72 hours of sexual intercourse.
Women's groups and other supporters argued easier access would reduce the number of unwanted pregnancies and abortions.
Conservative opponents said wider availability would lead to more teen-age promiscuity and sexually transmitted diseases.
Barr agreed to monitor enforcement of the age limit and to limit Plan B's distribution to health clinics and stores with pharmacies, the FDA said. The pills should be available in dual nonprescription and prescription packages by the end of the year. Prescription packages are available now.
''While we still feel that Plan B should be available to a broader age group without a prescription, we are pleased that the agency has determined that Plan B is safe and effective for use by those 18 years of age and older as an over-the-counter product,'' Barr Chief Executive Bruce Downey said in a statement.
The company originally had sought permission to sell Plan B over the counter without age limits. Throughout the process, two Democratic senators blocked votes on President George W. Bush's nominees to run the FDA. After the FDA decision, Sens. Patty Murray of Washington and Hillary Rodham Clinton of New York dropped their objections to a Senate vote on the confirmation of Bush's current pick, acting FDA Commissioner Andrew von Eschenbach, a Murray spokeswoman said.
Since Barr's initial bid in April 2003 to allow sales of the contraceptive without a prescription, repeated delays sparked charges that the FDA let politics override science.
In December 2003, a panel of outside advisers voted 23-4 to recommend switching Plan B from a prescription to over-the-counter drug. FDA staff scientists agreed, but a senior official rejected approval over concerns that young girls might not be able to use the pills safely.
Barr submitted a new bid for over-the-counter sales to females 16 and older. The FDA deferred a decision on that plan and last month proposed the 18-and-older scenario.
Plan B pills contain higher doses of progestin, a hormone used in prescription birth-control pills. Women are supposed to take two tablets 12 hours apart.
The pills block the release or fertilization of an egg.
Some research suggests Plan B also may keep a fertilized egg from attaching to the womb, and some opponents considered that mechanism equal to an abortion.
Plan B is different from RU-486, a pill that causes an abortion early in pregnancy by blocking the hormone that keeps a fertilized egg implanted in the uterus. RU-486 also is known as Mifeprex or mifepristone.
Shares of Barr, which is based in Woodcliff Lake, New Jersey, rose 1.03 dollar, or 1.8 per cent, to 59 dollar in morning New York Stock Exchange trade.