WASHINGTON, DC—The recent decision by Human Services Secretary Kathleen Sebelius to restrict the sale of the morning after pill Plan B One-Step, manufactured by Teva Health, has sparked heated controversy. On January 6, advocates for unrestricted access to the emergency contraceptive took their case to the President’s Council of Advisers on Science and Technology, asking them to determine the basis for the administration’s controversial decision last month to continue requiring that girls under age 17 must obtain a prescription to receive the morning after pill.
In brief presentations squeezed into a meeting of the President’s Council of Advisers on Science and Technology, five experts contested Secretary Sebelius’s rejection of the Food and Drug Administration’s (FDA) approval of over-the-counter-sale of the product. They were each allotted two minutes.
“We are asking you to work with us . . . to readdress this decision, find out how it was made and why,” Wayne C. Shields told John P. Holdren, the chairman of the council. Mr. Shields is president of the Association of Reproductive Health Professionals, a trade organization with offices in Washington. Francesca T. Grifo of the Union of Concerned Scientists quoted Secretary Sebelius’s December 7 letter, which rejected the Food and Drug Administration’s (FDA) plan to make Plan B One-Step available to girls younger than 17 without a prescription. She noted, “Secretary Sebelius used phrases like ‘based on my review’ and ‘my conclusion. This is exactly the situation which scientific integrity policies are created to prevent: namely, a non-scientist, political appointee overturning a decades-long process of scientific research and review both inside and outside of the FDA.”
Afterward, however, she and the other advocates said the issue did not involve “scientific integrity” as commonly understood. Mr. Shields said, “This not about fraud, not about misconduct, it is about standing up to the stated principles.”
As Obama’s adviser for science and technology, Mr. Holdren has no direct influence over either Secretary Sebelius or FDA Commissioner Margaret Hamburg. Thus, itis unclear how Sebelius’s decision regarding access to the morning after pill short of President Obama ordering her to reverse it. Shortly after Secretary Sebelius released her controversial decision, the president announced that he supported it. Mr. Holdren told the speakers: “I will communicate the concerns that were expressed here to my boss.” He also addressed the issue of scientific integrity: “What scientific integrity requires is that the clearest and most objective evidence be made available” to decision-makers. That does not necessarily guarantee that the scientific findings alone will determine the outcome.”
Secretary Sebelius claimed that only about 10% of girls are able to get pregnant at age 11. In a statement, Commissioner Sebelius said her action "reflects my conclusion that the data provided as part of the actual use study and the label comprehension study are not sufficient to support making Plan B One-Step available to all girls 16 and younger without talking to a healthcare professional."
The studies submitted to FDA, as published, included girls aged 12 to 17. The study reported that at least 79% of the youngest girls could understand the instructions. Administration of the single-dose pill must be taken within 72 hours of unprotected sex; thus, if a prescription is required that time limit is likely to be exceeded before a girl can obtain one.
"The sooner Plan B is taken, the better it works," said Amy Niemann, vice president of Teva Women's Health. She added, "That is the entire rationale for having widespread availability for this product." Nancy L. Stanwood, MD, MPH, section chief of family planning at Yale School of Medicine, noted that full over-the-counter (OTC) status would have made emergency contraception available to many more people who need it. She noted, “The irony of Plan B not being OTC for women of all ages is that it has not been available for the women who need it the most… "Teens may be sexually active for a while before they see a doctor to get a prescription for contraceptives. ... [With emergency contraceptives] they don't just have to hope the condom doesn't break. There is something they can do."
Another group of women that may be in need of the morning after pills are rape victims. Dr. Stanwood said, "Many women who have been raped do not come in for medical care, and many do not see a doctor in a timely manner… With over-the-counter sale of Plan B, at least they could do this. And young women are more likely to be raped. We want these women to get medical care, but most do not do it quickly."
Plan B One-Step facts:
- Plan B should be taken within 72 hours (three days) of unprotected intercourse. When taken within 72 hours, it decreases the chance of getting pregnant by 89% (from 8% without Plan B to 1% with Plan B).
- Plan B is even more effective when taken within 24 hours. Effectiveness decreases the longer a woman waits to take it.
- Plan B is not an abortion pill. It contains levonorgestrel, a synthetic version of the hormone progestin. The abortion pill RU-486 contains a completely different drug.
- Plan B works mainly by preventing release of eggs from a woman's ovary, although it may also prevent sperm from fertilizing the egg. However, if a fertilized egg already has been implanted, the pregnancy continues normally even if a woman takes Plan B.
- Plan B may cause side effects. The most common side effect is nausea, which occurs in about 25% of women after taking Plan B. Other side effects may include abdominal pain, fatigue, headache, and heavy menstrual bleeding.