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'Morning-After' Pill Approved for Over-the-Counter Sales

FDA restricts access for those under 18; ruling follows three-year delay

THURSDAY, Aug. 24, 2006 (HealthDay News) -- After three years of delay, the U.S. Food and Drug Administration on Thursday approved the over-the-counter sale of the emergency contraceptive Plan B, sometimes called the "morning-after" pill.

However, the approval came with stiff restrictions: Women under the age of 18 cannot purchase the pills without a doctor's prescription, a condition set to respond to the concerns of conservative groups that the contraceptive's easy availability would encourage premarital sex.

"Our assessment is that this younger age group would strongly benefit from consultation with a health-care provider before using the product," Dr. Steven Galson, director of the FDA's Center for Drug Evaluation and Research, said during a news conference Thursday. "The application did not contain enough information about this age group to make us comfortable to do the switch fully for those younger people."

The drug can only be dispensed over-the-counter by a licensed pharmacist from a pharmacy.

The age restriction is meant to ease concerns for pharmacists as well, Galson said. "We have all kinds of restrictions that click in at 18," he said. "We thought for this program to practically work, the age 18 made sense. We have heard feedback from pharmaceutical groups that the proliferation of other restrictions was going to make it difficult for them to keep it straight. We thought this had the greatest chance of working successfully."

According to Galson, the announcement "concludes an extensive process that included getting expert advice from two of the FDA's advisory committees, and an opportunity for public comment. Duramed's [the company that will be marketing the drug] application raised novel issues regarding simultaneously marketing both prescription and non-prescription drugs. The FDA remains committed to a careful and rigorous scientific process."

Both over-the-counter and prescription versions of Plan B will be sold in a single package.

"It's up to the company as to when they can get the packaging and labeling done," Galson said. "The new packaging will have to be available before the drug can be sold."

The controversy over the morning-after pill has been particularly heated during the past year, after the FDA announced it would delay any decision on the matter, despite the fact that two FDA advisory committees had concluded the product was safe enough to sell over the counter.

Reaction from groups that have been advocating for the over-the-counter sale of this contraception was swift in coming.

"The American Society for Reproductive Medicine [ASRM] is pleased that FDA has approved making emergency contraception available to women aged 18 and over," ASRM President Dr. Joseph S. Sanfilippo said in a statement released Thursday morning. "We are encouraged that FDA has heeded the advice of its Reproductive Health Drugs Advisory Committee and the Over-the-Counter Advisory Committee, and has recognized that the morning-after pill is a safe and effective way to protect against pregnancy in an emergency. ASRM has, from the beginning, advocated for the over-the-counter availability of Plan B and has taken every opportunity to comment to [the] FDA in writing and through its representatives."

But other supporters of Plan B, such as Planned Parenthood, said the FDA's decision to require age restrictions will hamper efforts to reduce the nation's 3 million annual unplanned pregnancies, and, by extension, the number of abortions.

"While we are glad to know the FDA finally ended its foot-dragging on this issue, Planned Parenthood is troubled by the scientifically baseless restriction imposed on teenagers," Planned Parenthood President Cecile Richards told the Associated Press. "The U.S. has one of the highest rates of teen pregnancy in the Western world. Anything that makes it harder for teenagers to avoid unintended pregnancy is bad medicine and bad public policy."

But Plan B opponents fear that the condition to require a doctor's prescription for young women under 18 will do little to limit teen promiscuity, the AP said.

"If the FDA thinks that enacting an age restriction will work, or that the drug company will enforce it... then they are living in a dream world," said Wendy Wright, president of Concerned Women for America, which led the opposition to the contraceptive.

The FDA originally approved Plan B as a prescription drug in 1999. In 2001, more than 60 health groups petitioned the U.S. government to make emergency contraceptives available without a prescription and, in December 2003, the FDA advisory committees concluded that Plan B was both effective and safe. They overwhelmingly recommended that the agency make Plan B available without a prescription.

But in an unusual move, the FDA ignored the advice of the committees, and instead told drug maker Barr Pharmaceuticals it was delaying its decision.

Soon after, the FDA added another condition by informing Barr that the drug couldn't be sold over-the-counter until more studies were done. At the time, the FDA denied that the move was politically motivated but instead arose from concern that young teenage girls would not be able to use the product safely.

The pro-choice Center for Reproductive Rights had sued the FDA to allow over-the-counter sales of Plan B, and recently subpoenaed White House e-mails and other documents on the matter.

Plan B is an extra high dose of regular birth control that needs to be taken within 72 hours of unprotected intercourse to be effective. Essentially, the drug prevents pregnancy by delaying ovulation. It does not interrupt an already implanted pregnancy.

"Emergency contraception is a method of preventing pregnancy after contraceptive fails or after unprotected sex," Galson said. "Plan B acts primarily by stopping the release of an egg from the ovary. It's important to note that Plan B is not intended for routine use. It's an emergency contraception."

The FDA's decision on Plan B could also end the stalemate over President Bush's nomination of Dr. Andrew von Eschenbach to head the agency. Sens. Hillary Rodham Clinton, D-N.Y., and Patty Murray, D-Wash., said Thursday that they would lift their block on the nomination, making it likely von Eschenbach will win confirmation as FDA chief, possibly as early as next month, the AP said.

More information

For more on Plan B, visit the FDA.

SOURCES: Aug. 24, 2006, news conference with Steven Galson, M.D., director, FDA Center for Drug Evaluation and Research; Aug. 24, 2006, statement, American Society for Reproductive Medicine
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