Science or Politics? Morning After Pill Put on Hold

On May 6, 2004, the Food and Drug Administration (FDA) rejected Barr Pharmaceuticals’ request to sell emergency contraception over-the-counter.

Barr’s product, called Plan B and commonly known as the morning after pill, works to prevent pregnancy when taken up to 72 hours after unprotected sex. Medical professionals do not consider Plan B an abortion pill, because unlike RU-486 or Mifeprex, it prevents pregnancy from starting but does not terminate a pregnancy in progress.

The science

Plan B consists of two high doses of levonorgestrel, a hormone frequently used in birth control pills. Like the pill, Plan B interferes with ovulation or prevents the implantation of a fertilized egg.

The morning after pill is currently available by prescription only. In order to sell it over-the-counter, Barr pharmaceuticals conducted a study involving 585 women to verify the drug’s safety and usability. To determine if a drug can be sold without a prescription, federal regulators ask three crucial questions: Can patients diagnose the problem themselves? Can they be trusted to treat the problem effectively? Can they understand the drug’s label without a physician?

In December 2003, an expert advisory panel voted 27 to 0 that the drug could be safely sold over-the-counter. The group also voted 23 to 4 that Plan B should be sold without a prescription.

The decision

The director of the FDA’s Center for Drug Evaluation and Research, Steven K. Galson, signed the "not approvable" letter anyway, going against the advisory panel’s recommendation. Such a move is almost unheard of, since the FDA typically follows the advice of its staff and committees.

Galson argues that Barr Pharmaceuticals failed to prove that girls age 16 and younger could use Plan B without a physician’s guidance. The company’s study included only 29 girls younger than 17 years old and no girls younger than 14 years old out of the 585 women tested.

The politics

Galson denies that politics influenced his decision, but emergency contraception is clearly a politically charged issue.

Pro-life advocates employ familiar anti-abortion arguments to condemn the morning after pill, so there is some pressure on President Bush to prevent the drug from becoming widely available. Some say politics has everything to do with the FDA decision, and that the White House has pressured the FDA to stall the release of Plan B until after the election.

Anti-abortion groups like Concerned Women for America have voiced unique concerns about Plan B. Wendy Wright, spokeswoman for Concerned Women for America, equates greater availability with unspecified greater harm and possible abuse of women. Although increasing access to the morning after pill is likely to result in fewer abortions, Wright told the Washington Post that her group feels the drug has much potential for harm to women and girls if it is easily available.

But the American College of Obstetricians and Gynecologists disagrees. The ACOG believes all of the safety issues have been resolved and only politics can keep Plan B off of the shelves.

44 Senators wrote FDA panel members to urge them to reject Barr Pharmaceuticals’ proposal, linking the morning after pill with abortion and arguing that the drug will encourage promiscuity. Since there is no embryo, the concern is focused on the woman and her right to decide her own sexual behavior. This is a new public argument.

USA Today reports that Frank Davidoff, a member of the FDA non-prescription drugs advisory panel, explained that there is no evidence that emergency contraception will encourage sex among teenagers or unsafe sex. Dr. Scott Spear of the Planned Parenthood Federation of America echoed this sentiment in The New York Times when he noted that the FDA is not in charge of assessing the public’s behavioral response to the release of a particular drug.

Dr. Spear explained that the FDA must decide if the drug is safe and effective, not whether or not couples will stop using condoms when it is made available. To clarify his point, Spear pointed out that the FDA is unlikely to consider whether or not patients will start eating more cheeseburgers when deciding if anti-cholesterol medicine should be sold on the shelf.

Wendy Wright counters that one cheeseburger can’t kill you, while one unsafe sexual encounter can.

But the question remains, is it the FDA’s job to consider how some people may or may not change their behavior when a drug is released? Is there really a link between promiscuity and contraceptives? Who has the right to determine someone else’s sexual behavior?

The compromise

Galson claims to have based his decision on the lack of information about the drug’s impact on young girls, so the FDA will allow girls 16 and over to buy Plan B without a prescription. While Barr Pharmaceuticals is encouraged by the possibility, it presents a logistical nightmare. Would girls have to show ID to the clerk? Would Plan B be kept alongside the cigarettes behind the counter? Would there be a penalty for giving the drug to a girl under age 15 who had not consulted a doctor? Would boys 15 and under be prevented from buying the product? Barr is also concerned with meeting prescription and non-prescription labeling requirements in a single package.

Creating an age requirement to purchase a drug over-the-counter is unprecedented. The notion creates a web of questions that will, at the very least, keep Plan B off of the shelves for a while. However, Barr CEO Bruce Downey recently told reporters that he believes it will take "months rather than years" to get Plan B on the shelf.

Do you agree with the FDA decision? Should women and girls be able to access emergency contraception over-the-counter? What does it mean when policy is created by administrators who disagree with scientists and doctors? How did your senators vote? Discuss these issues with other WomenMatter readers in one of our online forums. If healthcare is an important Life issue for you, sign up for an e alert. Don’t forget to register to vote and to let your representatives know what you think.

Posted on: 5/13/2004