Plan B still Behind the Counter; Dr. Realini weighs in
On December 7, U.S. Department of Health and Human Services (HHS) Secretary Kathleen Sebelius rejected the recommendation of the Food and Drug Administration (FDA) to make Plan B One-Step® available without a prescription without regard to age.
The FDA's imminent ruling would have allowed, for the first time, an emergency contraceptive to be stocked on grocery and drugstore shelves and sold over the counter. Instead, Sibelius' unprecedented overruling of an FDA recommendation means that this "morning-after pill" will remain behind the pharmacy counter, available without a prescription only to those age 17 and over. Because a prescription is required for those 16 and under, the product will remain behind the counter, so that age can be verified.
Background on Plan B
Plan B One-Step® is a single 1.5 mg dose of the progestin levonorgestrel, a synthetic progesterone-like medication. When taken within 72 hours of unprotected intercourse, this medication reduces the chance of pregnancy by up to 89%. It is actually effective for up to 5 days after unprotected sex, but the sooner it is taken, the more effective it is. This decreasing effectiveness with the passage of time is part of the rationale for easy access to the medication.
Levonorgestrel is not an abortion pill; unlike mifepristone (RU486), Plan B One-Step® does not disrupt a pregnancy that has implanted in the uterus. Progestin-only emergency contraception works mostly by preventing or delaying ovulation (the release of an egg by the ovary). There is little evidence of any effect at all once the egg has been fertilized by a sperm. However, as with other forms of hormonal birth control, the possibility of some post-fertilization action has not been conclusively ruled out.
Levonorgestrel is exceptionally safe, with no deaths or serious complications and no contraindications to its use. There is no evidence that its availability - or the availability of any form of contraception - encourages teens (or anyone) to have sex, or to take risks.
Advocates Dismayed
Prevention advocates are greatly disappointed at HHS's obstruction of over-the-counter availability of emergency contraception. This action keeps in place significant barriers to access for women of all ages. This ruling means that emergency contraception will continue to be available only during pharmacy hours, and only to those brave enough to ask for it.
Secretary Sibelius cited concerns about very young teens and pre-teens, in spite of the fact that FDA's scientific experts, after reviewing a great deal of data, determined that Plan B One-Step® meets the regulatory standard for nonprescription drugs and that it should be approved for all females of childbearing potential.
Over-the-counter access to emergency contraception has also been endorsed by the American Medical Association, the American Congress of Obstetricians and Gynecologists, the American Academy of Pediatrics, and the Society for Adolescent Health and Medicine.
Dr. Susan Wood, the former FDA official who resigned in 2005 to protest the Bush administration's handling of Plan B, pointed out that many over-the-counter drugs have not been studied in preadolescents and are more dangerous than levonorgestrel. Acetaminophen (Tylenol® and others), for example, can be fatal in overdose, but is sold over the counter.
Dr. Realini's Perspective
Dr. Janet Realini, President of Healthy Futures of Texas, expressed her frustration at the continued confusion of Plan B with abortion. "Emergency contraception is NOT the same as abortion," she says. "Plan B works by preventing fertilization. It does not interfere with a pregnancy that is already implanted, and it is unlikely that it has any effect at all after fertilization has occurred. In fact, by preventing unplanned pregnancy, emergency contraception can prevent abortions."
"Many people don't realize that conception (fertilization) does not happen at the time of sexual intercourse. Conception only occurs in the first 24 hours after ovulation, that is, when the ovary releases an egg. If sperm are in the Fallopian tube at that time, fertilization can occur. Since sperm can live up to 5 or 6 days in the female's reproductive tract, there is often lots of time between having unprotected sex and the fertilization of the egg by a sperm. This is the time when emergency contraception can work."
Dr. Realini, a family physician with 10 years' experience in a family planning program, points out that Plan B is a progestin, similar to medications that are used to prevent premature labor and that are sometimes used in attempts to prevent recurrent miscarriages. "Pro-" means "for", or "in favor of", and "-gestin" refers to pregnancy.
Dr. Realini cites the extraordinary safety of levonorgestrel. Progestins, even in high doses over long periods of time, are extremely safe. To emphasize the safety of Plan B, Dr. Realini has often said, "The only way I know of to hurt someone with this medication is to drop a case of it on their head from a third-story window."
Dr. Realini also points out that there is no evidence that contraceptives ("emergency" or otherwise) cause young people to have sex or to take risks. "Contraceptives are not the reason that young people have sex," she asserts. "I think it is misguided to focus on the contraceptives as the problem. We should instead be focusing helping young people make healthy decisions. With accurate information, effective programs, access to contraceptives, and the expectation of a bright future, more teens will delay becoming sexually active, and more will avoid unplanned pregnancy if they choose to have sex."
[Please pardon the spacing and fonts in today's message. Constant Contact's email site is particularly unstable today.]
