Plan B One-Step without age restriction

Excerpted from “Federal judge rules morning-after pill must be available for women of all ages,” Fox News, April 5, 2013 -- A federal judge ruled Friday that the morning-after pill known as Plan B must be made available over the counter for women of all ages. The decision Friday by U.S. District Judge Edward Korman ordered the FDA to make the pill, commonly referred to as the abortion pill, available for all ages. The decision means that unless the FDA appeals and is granted a stay, by this time next month a teenager 16 or under could walk into a local pharmacy and buy the pill off the shelf.

"This ruling places the health of young girls at risk," said Anna Higgins of the Family Research Council. "There is a real danger that Plan B may be given to young girls, under coercion or without their consent. The involvement of parents and medical professionals act as a safeguard for these young girls. However, today's ruling removes these commonsense protections."

The Center for Reproductive Rights, which filed suit against the age restriction, and other groups have argued that contraceptives are being held to a different and non-scientific standard than other drugs and that politics has played a role in decision-making. "I think this is a landmark decision in terms of providing women and girls in the United States access to a safe and effective form of birth control," said attorney Andrea Costello with the Partnership for Civil Justice Fund. Full story can be found here.

Commentary

Former Member of FDA Advisory Committee for Reproductive Health Drugs and CMDA Member W. David Hager, MD: “Plan B (levonorgestrel) has been available as an over-the-counter, 'emergency contraceptive pill' since 2003. This drug may inhibit ovulation if taken just before the time of ovulation, or, as stated in the package literature, it may inhibit implantation of a fertilized ovum. In the 27-4 vote by the Advisory Committee on Reproductive Health Drugs for Women to approve OTC availability for women 17 years of age and older, our opposition to its approval was based on: lack of data on repetitive use; lack of data on safety and efficacy among younger adolescents; and concern that this pill would be used in place of daily contraceptives by sexually-active women. The drug was not immediately made available as an OTC product.

"In 2011, Secretary of Health and Human Services Kathleen Sebelius overruled the FDA decision to make Plan B available to all females regardless of age without a prescription. She based her decision on the same concerns that we had in 2003. Concern had also been raised by data from a study by Glasier ⁱ which showed no effect on abortion rates with advanced provision of emergency contraceptives; and from a study by Raine ⁱⁱ which revealed no significant reduction in pregnancy rates with pharmacy access and advanced provision. Other studies have reported that subjects frequently do not take Plan B as prescribed in the package insert.

"Those of us who believe the science that supports life beginning at fertilization would be opposed to a medication that would inhibit implantation. Even if you did not believe such, however, a federal judge has now ordered that children may purchase Plan B without parental or healthcare professional knowledge. Since no prescription is required, these girls will not receive counseling to make them aware of the risks of sexually transmitted infections, pregnancy and the emotional consequences of non-marital sexual activity. They will be exposed knowingly or unknowingly to a drug that may act as an abortifacient.

"This is just another step in the calculated effort to minimize parental authority under the guise of 'decreasing unplanned pregnancies,' when the data does not support the contention that the medication decreases pregnancy or abortion rates. We have an even greater responsibility to encourage parents to inform their children of the risks that non-marital sexual activity incurs."

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i. Glasier A, Fairhurst K, Wyke S, et.al. Advanced provision of emergency contraception does not reduce abortion rates. Contraception 2004; 69:361-366.
ii. Raine TH, Harper CC, Rocca CH, et.al. Direct access to emergency contraception through pharmacies and effect on unintended pregnancy and STIs. JAMA 2005; 293:54-62.

CMDA Ethics Statement: Assisted Reproductive Technology
The Emotional Antecedent & Sequelae of Adolescent Sexual Activity by David Hager, MD (PDF)
The morning-after pill, abortion and informed consent, by Gene Rudd, MD (PDF)