FDA Approves Over-the-Counter Sales of Morning-After Pill

By Linda Orlando

There has been an ongoing debate for over three years about whether or not the "morning after" contraceptive pill should be more widely available over the counter. The Food and Drug Administration’s decision-making process spanned the terms of three different FDA commissioners, and the issue became a central part of the ongoing national debate over abortion rights. Advocates of making the pill more available believe that doing so will reduce abortions; critics of the pill assert that making it more widely available will increase abortions.

The drug, called Plan B, will be sold only in pharmacies and health clinics, and buyers must show proof of age. Anyone under the age of 18 will need a prescription to purchase Plan B, and men may buy Plan B for a partner. The prescription drug being sold now costs between $25 and $40 for a two-pill dose, but Barr Pharmaceuticals of Woodcliff Park, NJ, the manufacturer of Plan B, said that the cost may change now that the drug will be available without a prescription. The company has no plans currently to advertise the pills on television or radio, and the pills will not be sold to gas stations or convenience stores.

In a briefing on Monday, President Bush was asked whether he supported the intention by the acting commissioner of the FDA, Andrew C. von Eschenbach, to approve over-the-counter sales of Plan B. "I support Andy’s decision," he replied. Dr. von Eschenbach wrote in his decision that he believed age 18 is an appropriate cut-off age for sales of the drug because pharmacies already use that guideline to control sales of restricted nicotine and cold medicines. "This approach builds on well-established state and private-sector infrastructures to restrict certain products to consumers 18 and older," Dr. von Eschenbach. Abortion rights advocates, however, are quite critical of the age restriction.

The FDA’s approval of Plan B over-the-counter sales was generally expected, so there were many press releases already prepared to respond to the official announcement. Senators Hillary Clinton and Patty Murray said in a statement, "This long overdue decision is a victory for women’s health and for the American people who have been waiting for years for the FDA to act."

Last year, Senators Clinton and Murray placed a legislative hold on the nomination of Dr. Lester Crawford as FDA commissioner solely to pressure the agency to make a decision on Plan B. They lifted their hold after Health and Human Services Secretary Michael O. Leavitt promised a decision by Sept. 1 of 2005, and Dr. Crawford was then confirmed. But soon afterward, the FDA announced yet another delay in a decision on Plan B, which Clinton and Murray denounced. Just a few weeks later, Dr. Crawford unexpectedly resigned, and the two senators refused to let Dr. von Eschenbach’s nomination as commissioner advance without a Plan B decision. Last Thursday, they said that they would lift their hold, and a week later, the Plan B proposal was approved. Interesting sequence of events, to say the least.

Despite the FDA’s decision, controversy still remains, along with bitter feelings about the issue. "Let there be no mistake about it," said the Rev. Thomas J. Euteneuer, president of Human Life International, an anti-abortion group based in Virginia. "Today’s decision lies at the feet of President Bush and has created a lasting rift with the Catholic faithful who comprise a large part of his support base." But Kirsten Moore, president of the Reproductive Health Technologies Project in Washington, said, "We are pleased that a common sense, common ground agenda for reducing unintended pregnancy and the need for abortion finally won out."

Plan B is made from a synthetic hormone found in regular oral contraceptives. The first of the two pills should be taken within 72 hours of unprotected sex and the second 12 hours later. Like regular contraceptive pills, Plan B generally acts by preventing ovulation or fertilization. Plan B may in rare circumstances prevent a fertilized egg from becoming implanted, which is a component that abortion opponents decry. But regular oral contraceptives do that, too. Senator Tom Coburn, who is also a family practice doctor, strongly criticized the FDA’s decision, saying, "Exposing women to the high-dose hormones in Plan B without the guidance of a physician will put them at risk."

Both sides of the issue have quoted various statistics and research studies to support their opinions, but there are also studies that show both sides are wrong in their predictions of the pill’s effect on the number of abortions performed each year, as well as on the rate of sexually transmitted diseases. According to an editorial in the New York Times "Couples in the United States have so much unprotected sex that even if the pills were passed out like aspirin, they would be unlikely to cause a major change in abortion and disease rates." Critics of Plan B say that emergency contraceptives don’t work whether or not they’re available OTC, because people forget and leave them in the drawer. Supporters of Plan B say that making them available OTC will contribute to an ongoing decline in unintended pregnancy rates.

The bottom line in regard to the FDA’s decision is that it was not a public health one, but a political one. Three commissioners and numerous politicians, researchers, and analysts devoted countless hours to deciding whether this decades-old medicine, which has never been a good seller anyway, should be made available over the counter. Peter Barton Hutt, a former general counsel for the FDA, said, "I cannot recall any other issue in my 45 years of watching FDA that has garnered this much attention at all levels of government."