No Plan for Plan B: Politics keeps Emergency Contraception off the Shelves

The Food and Drug Administration (FDA) has again delayed over-the-counter availability of Plan B, an emergency contraceptive that allows women to prevent pregnancy for up to 72 hours after intercourse.

The decision greatly affects women’s ability to control their own reproduction, and has caused Dr. Susan F. Wood, the director of the FDA office of women’s health, to resign in protest.

Dr. Wood believes that the FDA has derailed Plan B because of abortion politics. Some anti-abortion activists liken the pill to an abortion, but Dr. Wood says that if it were made available over the counter, it could prevent 800,000 abortions per year.

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.

That was a year-and-a-half ago; so, why isn’t Plan B on our drugstore shelves?

The history

In May 2004, the director of the FDA’s Center for Drug Evaluation and Research, Steven K. Galson, signed a "not approvable" letter for Plan B, going against the advisory panel’s recommendations. Such a move is almost unheard of, since the FDA typically follows the advice of its staff and committees.

Galson argued that Barr Pharmaceuticals, which makes the product, failed to prove that girls age 16 and younger could use Plan B without a physician’s guidance. The company’s label-comprehension study included only 29 girls age 17 and younger and no girls age 14 and younger out of the 585 women tested.

The FDA decision gave Barr Pharmaceuticals two choices: redo the study and include more women age 16 and younger, or reapply to sell the drug only to women age 16 and older.

In July 2004, Barr Pharmaceuticals reapplied to the FDA to sell the drug over-the-counter with the age limit, requiring younger girls to get a prescription.

Over a year later, on August 26, 2005, the FDA deferred any decision on Plan B, claiming 60 days of public comment was needed. The FDA says it needs more time to gauge public reaction and decide how to monitor Plan B sales in order to make sure that girls aged 16 and younger don’t buy the emergency contraception without a prescription.

The politics

Democratic Senators Hillary Rodham Clinton (NY) and Patty Murray (WA) are outraged. The two women senators made a deal with Michael O. Leavitt, secretary of health and human services, in which they agreed to stop blocking the confirmation vote on Dr. Lestor M. Crawford, Bush’s nominee for food and drug commissioner. In exchange, Leavitt would make sure that the FDA came to a decision on Plan B by September 1, 2005.

Crawford is not the commissioner, but Clinton and Murray say Leavitt did not live up to his end of the bargain. Further, they argue that the FDA’s hesitancy is the latest example of the Bush administration’s tendency to suppress science that doesn’t fit the White House political agenda.

Anti-abortion groups like Concerned Women for America have put pressure on President Bush to stop the over-the-counter release of the drug. Wendy Wright, the spokeswoman for the group, equates greater availability with greater harm and possible abuse of women. Wright told the Washington Post that her group feels the drug could endanger women and girls if it is easily available. She did not explain this statement.

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. In 2004, 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.

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?

What do you think?

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Posted on: 9/4/2005