FDA: Doctor Must Still OK ‘Morning-After’ Pill
Overruling the recommendation of independent scientific experts, the Food and Drug Administration on Thursday rejected an application to make a “morning-after” birth control pill available without a prescription.
In a letter to Barr Laboratories, manufacturer of the emergency contraceptive Plan B, the agency said the company had failed to prove that girls younger than 16 could safely use the drug, now available by prescription, without the guidance of a doctor or other healthcare professional.
Some socially conservative groups praised the decision as a victory against promiscuity and unsafe sex. But some women’s rights groups and scientific experts, who contended that making the drug more accessible would dramatically reduce the demand for abortion, said they believe that the decision reflected the value the Bush administration had put on politics over science.
In rejecting Barr’s application to sell Plan B over the counter, the FDA laid out for the company what it needs to do to have another chance at winning approval, which the company said it would pursue.
Based on the FDA’s letter, the company must submit results from a new study “demonstrating that Plan B can be used safely by women under 16 years of age without the professional supervision of a practitioner licensed by law to administer the drug.”
Although Barr’s original study enrolled 585 women, “only 29 ... were 14-16 years of age, and none was under 14 years of age,” the agency said.
Alternatively, the FDA told the company, it could submit new information seeking to make Plan B available over the counter to women 16 and older but requiring girls younger than 16 to have a prescription for the drug.
“Wide availability of safe and effective contraceptives is important to public health,” the FDA said in its letter. “We look forward to continuing to work with you if you decide to pursue either of these options.”
Supporters of making emergency contraception more widely available said the approach by the FDA masked a highly unusual and politicized process. They said it was extremely unusual for the agency to overrule not only its outside advisors but also its staff.
They also questioned the timing of the decision, originally due in February. Because of the time it will take to submit a revised application, it would be at least six months and more likely a year -- after this fall’s elections -- before Plan B could be made available without a prescription to at least some women.
“This sounds reasonable, but it is not reasonable at all,” said James Trussell, director of the Office of Population Research at Princeton University and an FDA-appointed expert who voted in December to approve Barr’s application.
“Unfortunately, for the first time in history, the FDA is not acting as an independent agency and is acting as a tool of the White House,” he said. “And it’s really a very sad day when politicians start making medical decisions.”
The agency will not officially release its decision on Plan B until this morning, but Thursday night a top FDA official defended the integrity of its process.
“Every decision that the FDA makes is based strictly on health and science,” said Peter J. Pitts, associate commissioner for external affairs. “That remains true.”
Pitts declined to respond to allegations -- made by those who want to see the drug more widely available -- that FDA staff members were called to the White House to discuss the Plan B application.
Concerned Women for America and the Family Research Council, both of which strongly opposed the proposal, praised the decision.
“The FDA is right to be cautious about making a potent drug that can harm women available next to candy bars and toothpaste,” said Wendy Wright, senior policy director at Concerned Women for America, a public policy organization. “The morning-after pill is a pedophile’s best friend.”
The Family Research Council said the FDA had put “the safety of American women and girls above the wishes of the pro-abortion lobby.”
But supporters of over-the-counter emergency contraception, including the National Partnership for Women & Families and NARAL Pro-Choice America, said the decision would result in more unwanted pregnancies and abortions.
Women will be “denied timely access to a safe, effective and FDA-approved way to prevent pregnancy, and we hold the Bush administration responsible for that,” said Kirsten Moore, president of the Reproductive Health Technologies Project.
Officials at Barr, who were notified of the FDA’s decision at the close of business Thursday, said they would make the best of it.
“While we are disappointed that FDA did not approve our application at this time, we are encouraged by FDA’s suggestions and look forward to working with the agency toward approval,” Bruce L. Downey, Barr’s chairman and chief executive, said in a statement.
Barr Vice President Carol A. Cox called the FDA’s guidance “a silver lining” and said the company would “pursue one or both of those options” laid out by the agency.
The next step for the company, Cox said, is to meet with FDA officials and then decide what to do. “We would like to do whichever one is faster,” she said.
The FDA approved Plan B as a prescription drug in 1999; another emergency contraceptive, Preven, was approved in 1998.
Since then, millions of women in the United States have used such drugs to prevent pregnancy. But because the first pill must be taken within 72 hours -- and preferably within 24 hours -- after unprotected intercourse, it is possible that millions of women who wanted to use the drug did not have time to see a doctor and get to a pharmacy.
Plan B and Preven contain higher doses of the hormones that are in regular, once-a-day birth control pills.
Clinical studies have shown that for more than 7,000 women who took the drug correctly, the rate of pregnancy from unprotected sex was cut from slightly more than 8% to about 1%. In one study, when women took the first pill within 72 hours of having unprotected sex and then took the second pill 12 hours later, the drug was 89% effective.
In December, a joint FDA advisory panel voted 23 to 4 to make the morning-after pill available without a prescription.
California and four other states now allow pharmacists to dispense the drug without a doctor’s prescription, but even in those states, most women do not know about the morning-after pill’s availability.
In California, which has spent about $1 million to advertise the “Pharmacy Access” program since it went statewide in January 2002, only 14% of pharmacies have emergency contraceptives in stock. And only 1 in 10 California women ages 15 to 44 is aware of the program, according to a recent survey by the Kaiser Family Foundation.
