FDA Allows OTC Sales of Plan B
Thursday, August 24, 2006; 10:15 AM
The Food and Drug Administration approved an application today making the long-debated emergency contraceptive Plan B, commonly known as the "morning-after pill," available without a prescription to women 18 and older.
The FDA said Barr Laboratories, the maker of Plan B, could begin selling the drug, but only at pharmacies and health clinics. Women purchasing the drug will have to show proof of age.
Many social conservatives in and out of Congress have battled to keep the drug from becoming available without a prescription. Some say that could encourage promiscuity, and others say use of the pill causes a very early abortion. Their position had for almost three years trumped an overwhelming medical and scientific consensus that the drug could be safety dispensed by a pharmacist without a prescription.
The approval came a year after former FDA commissioner Lester M. Crawford created a firestorm by ruling that the agency did not have the authority to approve a drug for over-the-counter use for women while requiring prescriptions for girls. But in recent weeks, President Bush and acting FDA Commissioner Andrew C. von Eschenbach signaled that they were willing to back off from that position and allow the drug to be available, as Barr -- and many women's health advocates -- have long advocated.
An approval also opened the way for von Eschenbach to be confirmed as permanent FDA commissioner. Sens. Hillary Rodham Clinton (D-N.Y.) and Patty Murray (D-Wash.) put a hold on the nomination last year because of what they said was the agency's refusal to make a decision about the drug. They accused the administration of politicizing science regarding Plan B by not accepting the recommendations of an expert advisory panel and the FDA's own scientific staff.
The morning-after pill is a high dose of the most common ingredients in regular birth-control pills. Taken within 72 hours of unprotected sex, the two-pill series can significantly lower the chance of pregnancy. Women's health advocates have pushed for easier access to the drug because it has often proved difficult for women to get prescriptions quickly.
"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," said Bruce L. Downey, Barr's chairman and chief executive. "Although Plan B will continue to be available to all women of child- bearing age, we believe making Plan B available without a prescription to those 18 and older will ensure that millions of women have more timely access to an emergency oral contraceptive following unprotected sexual intercourse or a contraceptive failure."
While the FDA concluded that the pill works like a traditional contraceptive -- preventing an egg from becoming fertilized -- it has not ruled out the possibility that it can also prevent a pregnancy by keeping a fertilized egg from implanting in a woman's uterus. That possibility has led some social conservatives to liken emergency contraception to abortion.
Plan B was approved for prescription use in 1999. Since 2003, the Women's Capital Corp. and Barr, which later acquired rights to Plan B, have sought to sell it over the counter.
Von Eschenbach made his surprise announcement that the agency would consider approving sales of Plan B without a prescription to women 18 and older the day before he was scheduled to appear before a Senate committee for his confirmation hearing.
At the Aug. 1 hearing, he said he decided to consider allowing women to buy Plan B without a prescription "not on a political ideology but on a medical ideology."
Data did not support safe over-the-counter use by minors, he said: "I believe 18 is appropriate. It's a cut point. We have to have some cut point."
Von Eschenbach added that "no one told me what I should or could do. No one told me what decision I must and must not take."
Bush signaled his support in an Aug. 21 news conference.
"I believe that Plan B ought to be -- ought to require a prescription for minors. That's what I believe," he said, adding the he supports "Andy's decisions." Both actions have enraged social conservatives, who subsequently intensified their campaign to block the approval.
The group Concerned Women for America has led the opposition to wider availability of Plan B, and its president, Wendy Wright, criticized the administration last week for its apparent change of position. She called for von Eschenbach's nomination to be withdrawn, 8citing his "pandering to political activists and a drug company."
"The FDA would be overstepping its precedent and authority to make Plan B available nonprescription," Wright said on the organization's Web site. "It defies common sense to allow easy access to a high-dose drug, based on the age of the person who buys it, when a low dose for anyone who requires medical oversight."
Word that approval was imminent set off a flurry last night on Capitol Hill and among family-planning advocates.
"We're very excited about what might happen tomorrow," said Kirsten Moore of the Reproductive Health Technologies Project.
"This is something that women's health groups have been working on for more than a decade," said Amy Allina of the National Women's Health Network. "If the decision comes out as we expect it to, that's a real victory."
Allina added that restricting access to women 18 and older is disappointing. "There's no medical or scientific reason for restricting access. It sends a message that it's somehow less safe for younger women, which just isn't true," she said.
Even as a prescription drug, the morning-after pill has been a flash point in the abortion debate. Many antiabortion pharmacists nationwide have been refusing to fill prescriptions, and many emergency rooms at hospitals run by religious groups do not offer the drug.
But advocates of emergency contraception have also had success in helping to legalize nonprescription "behind-the-counter" dispensing of the drug in five states, including California and Washington.
Researcher Meg Smith contributed to this report.