FDA delays OTC status for ‘morning after’ pill
FDA delays OTC status for morning after’ pill
Advocates want pill sold to those older than 16
The U.S. Food and Drug Administration (FDA) might have avoided one kind of controversy over the so-called "morning-after" contraceptive, but it created another by indefinitely delaying approval for the pill known as Plan B to be sold over the counter (OTC).
The FDA’s decision to withhold approval came more than two years after an FDA advisory panel first overwhelmingly approved OTC status for Plan B.
Lester Crawford, DVM, PhD, acting commissioner of the FDA, announced in September that the novelty of the drug manufacturer’s application, which would make Plan B (Barr Pharmaceuticals Inc.) available OTC to girls and women older than 16 but prescription-only for girls younger than 16, posed regulatory and policy questions that the FDA felt necessary to resolve before approving OTC status for the drug.
In delaying its decision on whether to approve OTC status for the emergency oral contraceptive, the FDA overruled a recommendation by one of its own advisory bodies, the Center for Drug Evaluation and Research, which voted in August that Plan B be made available OTC for women 17 and older and by prescription to girls younger than 17.
It also apparently resulted in the departure of one of the FDA’s senior women’s health officials, the FDA’s assistant commissioner for women’s health, Susan Wood, PhD, who resigned following the announcement to delay OTC status, to protest the agency’s overruling staff scientists and refusing to approve OTC sales of Plan B. The indefinite delay by the FDA, she said, "is contrary to my core commitment to improving and advancing women’s health."
The decision by the FDA to delay approval for OTC status for Plan B while it works on what it says are regulatory obstacles is the latest holdup in the manufacturer’s two-year battle to gain OTC approval. But many states already have passed laws pertaining to emergency contraception (EC).
EC supporters say easier access to the drug is needed to make sure women get the pills in time. Emergency contraceptive pills are concentrated doses of the hormones found in regular oral contraceptives, and should be taken within 72 hours of unprotected intercourse to be effective, most experts say.
Opponents, who include some conservative lawmakers and advocacy groups, say wider availability could increase promiscuity and sexually transmitted diseases, especially among minors. Some Democrats and women’s groups have charged the FDA with letting conservative politics interfere with scientific data.
The Alan Guttmacher Institute (www.agi-usa.org), a not-for-profit organization conducting sexual and reproductive health research, policy analysis, and public education, finds that state-level lawmakers nationwide have addressed EC from two approaches — writing laws requiring hospitals to make EC available to victims of sexual assault, or letting pharmacies provide EC without prescriptions under collaborative practice agreements with physicians or in accordance with other state protocols.
Three states have adopted restrictions on EC ranging from excluding EC from Medicaid coverage to excluding EC from mandates that compel coverage for contraception.
Eight states require hospitals to provide EC-related services to victims of sexual assault. Seven states require hospital emergency departments to provide information about EC, and one state requires health care providers who personally object to EC to refer patients to other providers. Six states require emergency departments to dispense EC upon request by victims of sexual assault.
Seven states already allow pharmacists to dispense EC without a doctor’s prescription, under certain conditions, five states let pharmacists distribute EC under collaborative practice agreements with physicians, and three permit pharmacists to distribute EC under state-approved protocols.
Medical associations are divided over EC, particularly for minors. The American Association of Pro-Life Obstetricians and Gynecologists praised the FDA for delaying OTC approval of Plan B; in a statement at the time of the decision, the organization stated that EC obtained over the counter not only could encourage unprotected sex, but also would keep girls from seeking physician care.
The American Medical Association, on the other hand, condemned the FDA more than a year ago for not approving OTC status for Plan B.
Those on both sides of the OTC argument agree, however, that the FDA’s decision to delay approval of OTC status for Plan B likely means the drug will be prescription-only indefinitely.
The U.S. Food and Drug Administration (FDA) might have avoided one kind of controversy over the so-called morning-after contraceptive, but it created another by indefinitely delaying approval for the pill known as Plan B to be sold over the counter (OTC).Subscribe Now for Access
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