For over a year, the FDA has held adamantly to its stance that repeated delays in deciding whether to approve the over-the-counter sales of the "morning after" pill, Plan B, have nothing to do with abortion politics. Much of the science community, however, is finding this harder and harder to believe.
Last May, in an unprecedented move that went against the recommendation of the FDA's scientific advisory board, the agency refused to allow Plan B to be sold without a prescription. Many surmised that this decision could only have been based upon political ideology given that the drug had already been proven safe and effective (it contains the same ingredients as previously FDA-approved contraceptive pills); it had been approved for prescription sales since 1999; and studies indicated that Plan B's availability would not encourage sexual activity in adolescents.
According to federal drug officials, however, the rejection of Barr Laboratories Inc.'s proposal to sell the emergency contraception over the counter last year was based on a paucity of data about the impact the drug might have on younger girls. To some, this was a valid reason to delay a decision since some drugs act differently in adolescents than they do in adults and because the dosage of Plan B is higher than that of ordinary birth control pills. To many observers, though, this action appeared to be a stalling tactic, especially since many girls under seventeen are routinely prescribed birth control pills containing the same ingredients.
The stalling continues despite Barr Laboratories' submission of a new proposal that addressed the above safety concern and despite a promise made to Senators Hillary Clinton and Patty Murray that a decision would be made by September 1st. The Senators had agreed not to block votes on President Bush's nomination of Lester Crawford to become FDA commissioner in exchange for FDA making a decision. Crawford was confirmed as commissioner in July.
Last week, Crawford broke his promise and once again postponed a ruling on Plan B, even thought the new proposal would have required girls under seventeen to obtain prescriptions from their physicians in order to receive the emergency contraception. He claimed that while the available science supports over-the-counter access for girls over seventeen, there are still concerns regarding enforcement to ensure that Plan B will not wind up in the hands of younger girls.
By law, the FDA is required to make its decisions based on sound science, free of value-based, ideological beliefs. In light of the available data and the green light by the agency's advisory boards, the repeated stalling has put the FDA's credibility on the line. Critics have accused the agency of being influenced by anti-abortion groups who claim Plan B can terminate already-established pregnancies. Plan B is often lumped erroneously into the category of "abortion rights issues." A reminder is required of what Plan B is and is not.
Plan B Is Not RU-486
Emergency contraception, as its name indicates, has nothing to do with abortion at all, but is often confused with RU-486. Also known as the "abortion pill," or Mifeprex, RU-486 will terminate an already-established pregnancy if taken within seven weeks of a woman's last menstrual period. It blocks the action of progesterone, a hormone needed to sustain a pregnancy. It has been available in the U.S., by prescription only, since being approved by the FDA in 2000.
But Plan B is not an abortifacient. It acts only as a contraceptive, in that it prevents pregnancies before they start. In essence, it is the same as ordinary birth control pills but at higher dosages. Plan B works by delaying or inhibiting ovulation such that no egg is available to be fertilized, by inhibiting sperm motility, or by preventing the implantation of a fertilized egg into the uterine lining such that a pregnancy does not occur. Plan B does not act on an already-implanted embryo. Again, it cannot terminate an already-established pregnancy and therefore does not cause an abortion.
In order to be effective, however, emergency contraception must be taken within seventy-two hours of unprotected sex. It is this small window of opportunity that sparked the initial debates about making Plan B accessible over the counter. Women may be unable to reach their physicians in time to prevent an unwanted pregnancy in the event of condom breakage or accidentally skipped birth control pills.
When used correctly, emergency contraception can reduce the risk of unwanted pregnancy by up to 89%, which would very likely reduce the number of abortions. In this way, it seems surprising that anti-abortion groups have not actually embraced making Plan B accessible over the counter. As for enforcing the policy of requiring girls under seventeen to have a prescription: we already restrict the sale to minors of cigarettes, alcohol, and pornography. Efforts to do so with a pharmaceutical might even prove easier because pharmacists, rather than sales clerks, would regulate access.
Aubrey Stimola is an assistant director of public health at the American Council on Science and Health (ACSH.org, HealthFactsAndFears.com).
