FDA Approves Plan B's Over-the-Counter Sale
Friday, August 25, 2006
By the end of the year, American women will be able to walk into any pharmacy and buy emergency contraceptive pills without a prescription as a result of a Food and Drug Administration decision announced yesterday.
The decision means women will not have to go to a doctor first as long as they can prove they are 18 or older to a pharmacist, who will keep the drugs behind a counter. Younger teenagers will still need a prescription, and the pills will not be sold at gas stations, convenience stores or other outlets that do not have pharmacists.
The approval marks the first time a hormonal contraceptive will be broadly available in the United States without a prescription. The pills, which will be sold as Plan B, will probably cost about $25 to $40 per dose, and men will also be able to buy them.
The announcement was aimed at resolving one of the longest and highest-profile health controversies of the Bush administration, but opponents said they are considering plans to block the decision, either in court or in Congress.
"This decision has nothing to do with science or FDA rules but has everything to do with politics," Sen. Tom Coburn (R-Okla.) said.
Coburn and other social conservatives said that the high doses of hormones in the pills carry risks, and that making them more easily available will encourage sexual activity and result in more unwanted pregnancies and sexually transmitted diseases. Opponents also liken taking the pills to abortion, because they can sometimes prevent a fertilized egg from implanting in the womb.
"This is a bad decision for women, for girls, for parents and for public health," said Wendy Wright of Concerned Women for America, which led a campaign to block the decision. "The FDA's decision today will only make things worse for American women."
Women's health and family-planning advocates, while criticizing the FDA for the age restriction, hailed the decision as a long-overdue milestone that will make it much easier for women to prevent an unwanted pregnancy when they have unprotected sex or when another form of contraception, such as a condom, fails. Plan B will be particularly valuable to rape victims, they said.
"This is great news for women and great news for women's health," said Cecile Richards of the Planned Parenthood Federation of America. "This provides women with another important option."
The FDA's move reverses a decision it made three years ago prohibiting over-the-counter sales of the drug. That decision, which rejected the advice of the agency's outside advisers and internal reviewers, triggered intense criticism that the administration was letting political ideology influence scientific decisions, undermining the credibility and independence of an agency charged with protecting the nation's health.
Plan B, which consists of two pills containing a synthetic version of the hormone progestin used in standard birth-control pills, is highly effective in preventing a pregnancy if taken within 72 hours of unprotected intercourse (long before pregnancy tests usually work).
FDA officials said they have concluded after further review that too little safety data are available to approve the drug for teenagers younger than 18. But the agency ruled that the drug could be sold safely to those 18 or older because similar restrictions are already in place for other products, such as tobacco, nicotine and cold remedies containing pseudoephedrine.
"This approach builds on well-established state and private sector infrastructures to restrict certain products to consumers 18 and older," acting FDA Commissioner Andrew C. von Eschenbach said in a memo outlining the decision.
The agency said it is requiring Barr Pharmaceuticals Inc. to sell the pills in new packaging that clearly explains how best to use them and the possible risks. The company will also be required to ensure that the pills are sold only through pharmacies, retail stores with pharmacists and clinics with "licensed healthcare providers."
The company must take a number of steps to ensure compliance, including sending "anonymous shoppers" to check on stores, reporting its findings regularly to the FDA and referring any violations to state pharmacy regulators.
"This approach should help ensure safe and effective use of this product," von Eschenbach wrote.
Opponents charged that the requirement is meaningless because it does not specify how the company will ensure compliance or provide penalties for violations.
"There's nothing to stop a 20-year-old man who is having sex with a minor girl from buying the drug and giving it to her," Wright said. "Parents will be eliminated from the medical decisions being made about their daughters."
Plan B's backers, meanwhile, criticized the agency for not allowing the drug to be sold to everyone.
"We urge the FDA to revisit placing age restrictions on the sale of Plan B," said Sens. Hillary Rodham Clinton (D-N.Y.) and Patty Murray (D-Wash.). But because the decision represents "real progress" and an "important step in restoring the American people's faith in the FDA," the senators said, they were lifting a hold they had imposed on von Eschenbach's confirmation as FDA commissioner.
Steven Galson, director of the FDA's center for drug evaluation and research, defended the agency's handling of the issue in a briefing for reporters. She said officials took the time needed to evaluate the complicated issues and develop a plan that would make the drug available safely.
"We're convinced that, with this comprehensive program, we have adequate safeguards in place . . . to convince us that this drug will be provided as per the labeling," Galson said.
The FDA decision does not resolve other controversial issues swirling around the pills, including the refusal of hospitals run by religious organizations to offer them, of some pharmacies to stock them and of some antiabortion pharmacists to dispense them.
"The FDA doing a stupid thing doesn't change anything for those of us who need to do the right thing," said Karen Brauer, president of the group Pharmacists for Life International, which opposes the use of the emergency contraceptive.