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Prescriptions Required: The FDA Blocks Over-the-Counter Sales of Emergency Contraception
In an unusual move announced on May 6, the Food and Drug Administration (FDA) overruled its own panel of expert scientific advisors and rejected over-the-counter sales of Plan B, a widely prescribed form of emergency contraception (EC). In its rejection letter to Barr Laboratories, the makers of Plan B, the FDA stated concerns about teenagers' abilities to use the pills safely without a doctor's guidance, citing the small numbers of women under the age of sixteen involved in Plan B studies.
For several months now, the controversy surrounding the pending FDA decision about Plan B has hinged on young people and what's best for their health. Beginning in 2003, advocates on both sides of the contraception debate have closely monitored the FDA's decision-making process regarding emergency contraception, with a particular focus on teen access to the drug. Last Thursday's official rejection of over-the-counter sales of Plan B came as something of a surprise, since the decision contradicted overwhelmingly strong recommendations from two FDA scientific advisory panels that determined the drug could be safely sold without a doctor's prescription. This rare repudiation of advisory panel findings has raised widespread concerns among public health officials that politics may have gotten in the way of medical science.
Emergency Contraception: A refresher course
Emergency contraception, also known as the morning after pill, is essentially a highly concentrated dose of regular oral hormonal contraception (i.e. birth control pills). In the event of contraceptive failure or unprotected sex, the morning after pill can prevent a pregnancy from occurring. It's important to note that the morning after pill does not interrupt a pregnancy that's already in progress. Its slang name, "the morning after pill," refers to the fact that in order to be effective the pills must be taken quickly after an episode of unprotected sex - and the sooner the better. Taken within 72 hours of intercourse, the pills cut a woman's chances of getting pregnant by up to 89%.
Because of the time pressure associated with emergency contraception use, being forced to wait for a doctor's prescription can severely compromise the effectiveness of EC. As the prescription-only guidelines currently stand, weekends and holidays can make EC hard to come by for women who need swift prescriptions, and every hour counts. Studies on college campuses have shown a decline in pregnancy and abortion with wider availability of the morning after pill. Additionally, a study conducted by the Alan Guttmacher Institute estimated that emergency contraception could have prevented 51,000 abortions in 2000, and contraceptive advocates estimate that easier access to EC could have cut the nation's three million unintended pregnancies each year by as much as 50%.
December 2003: FDA Advisory Panels Vote 27-0 and 24-3
To understand what's surprising in last week's FDA decision, it's important to trace the decision back several months. In December 2003, a joint meeting of two FDA advisory panels of doctors and scientists made national news by voting 23-4 to recommend that Plan B be available for purchase without a prescription. The panels also voted 27-0 that the drug could be sold safely without a doctor's prescription. These nearly unanimous recommendations called easier access to emergency contraception a safe way to prevent unintended pregnancies and thousands of abortions, and noted that emergency contraception is sold without a prescription in numerous other countries, including England and Canada.
Although the FDA was originally supposed to follow up on the advisory panel's December vote with a decision on Plan B by February 20, 2004, the agency announced in early February that it would postpone its decision for 90 days, citing a need for more information on the drug and its use by teens.
May 2004: FDA Rejects Advisory Panel Recommendations
Last February, after the advisory panels submitted their recommendations for over-the-counter sales of EC, the FDA sent several follow-up questions to Barr Laboratories about Plan B. Many of the follow-up questions focused on issues raised in a letter signed by 49 Republicans in the House of Representatives which urged the FDA not to allow emergency contraception to be sold without a doctor's prescription. Of specific concern to House Republicans was young people's direct access to emergency contraception, which conservatives feared might encourage sexual activity among teenagers.
In last week's rejection letter to Barr Laboratories, the FDA said the over-the-counter application for Plan B was not approvable because the number of women under age 16 in Plan B studies was too small a sample size to "assess safety." The FDA also pointed out that no women under age 14 were included in the study. Pleased with the decision, Republican Representative Dave Weldon of Florida lauded the FDA for "siding with the nation's teens and their health."
The FDA Decision: Politics or Science?
Last week, almost as soon as the FDA had issued their formal rejection of Plan B's proposed over-the-counter sales, contraceptive advocates accused the agency of caving to conservative political pressure rather than the available medical research. Kirsten Moore, President of the Reproductive Health Technologies Project, criticized the FDA's reversal of its own advisory committee's findings, noting that "The FDA is supposed to make risk-benefit decisions about the public health, and it was absolutely clear that women would be best served by easier access to emergency contraception." Democratic Presidential nominee John Kerry also criticized the FDA's decision through spokesman Phil Singer, who issued a statement saying, "The White House is putting its own political interests ahead of sound medical policies that have broad support."
Support for the FDA rejection was widespread among social conservatives, including Republican members of Congress who lobbied President Bush on the issue and who encouraged the FDA to overrule the findings of their advisory panels. Christian Medical Association Executive Director Dr. David Stevens released a statement of approval, crediting the FDA: "FDA is wise to have carefully weighed the dangers of over-the-counter distribution [of Plan B] in the interest of women's health, and especially the health of younger women."
Plan B for Plan B
Within their rejection of over-the-counter sales of Plan B, regulators at the FDA left room for Barr Laboratories to modify their application and resubmit it in the future, either by providing new supplemental data to show that young teenagers can indeed use Plan B safely without a prescription, or by honing a proposal for a mixed-marketing approach. This approach would allow women over the age of 16 to buy Plan B without a prescription, while still requiring a prescription for women under the age of 16. Such a strategy would presumably require drugstores to check customers' ages.
Bruce Downey, Chief Executive Officer of Barr Laboratories, said that the company is "disappointed" by the FDA's decision, and that they would definitely pursue one or both options for resubmission. He was optimistic that the company could meet these new hurdles within months, possibly weeks: "Clearly…the door's open, and we plan to go through it." If Barr resubmits, the FDA will have an opportunity to revisit their decision and the accumulated medical evidence. In the meantime, women of all ages continue to need a prescription in order to access emergency contraception.
How to Get More Information
To find out more about EC, call the confidential toll-free hotline: 1-888-NOT-2-LATE (English) or 1-866-EN-TRES-DIAS (Spanish). You can also visit the Emergency Contraception Website at www.not-2-late.com.
To learn more about the Back Up Your Birth Control Campaign, you can visit the campaign website at www.backupyourbirthcontrol.org.
Read another Kaiser news piece about EC from earlier in the year.
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