HHS Secretary Kathleen Sebelius overruled FDA's decision to approve the OTC sale of emergency contraceptives to teenagers younger than 17.
Federal officials ruled last week that the emergency contraceptive Plan B One-Step will stay exactly where it is—behind the counter.
In what some argue was a purely political move, US Health and Human Services (HHS) Secretary Kathleen Sebelius rejected FDA’s plan to lift the age restriction that prevents pharmacies from selling the drug on OTC shelves. The decision does not impact access to Plan B for women aged 17 years and older, who can already buy it without a prescription.
Sebelius said her objection to the plan stems from concerns about label comprehension—a problem pharmacists confront daily when dispensing complex medications to patients of all ages. Specifically, she questions whether girls aged 11 to 16 are capable of understanding a medicine label that explains how to use Plan B safely.
WEIGH IN: Should Plan B be available to women younger than 17 without a prescription? Does it belong behind the counter or in the OTC aisle? Share your thoughts in the comments or cast your vote in our news poll.
The health secretary explained her reasoning: “The switch from prescription to over the counter for this product requires that we have enough evidence to show that those who use this medicine can understand the label and use the product appropriately,” she wrote in a statement
issued last Wednesday. “I do not believe that Teva’s application met that standard.”
Regulators at the FDA’s Center for Drug Evaluation and Research disagree. They approved a February 2011 request submitted by Teva Women’s Health to make the drug available to younger women.
In its review of the evidence, CDER determined that adolescent girls “understood the product was not for routine use” and that it doesn’t protect against sexually transmitted diseases. The data also showed that girls could use Plan B One-Step properly without the guidance of a physician, according to FDA Commissioner Margaret Hamburg, MD.
“I reviewed and thoughtfully considered the data, clinical information, and analysis provided by CDER,” said Dr. Hamburg, “and I agree with the Center that there is adequate and reasonable, well-supported, and science-based evidence that Plan B One-Step is safe and effective and should be approved for nonprescription use for all females of child-bearing potential.”
Pharmacists, physicians weigh in
By and large, physicians and other primary care providers support CDER’s assertion that Plan B should be accessible without a prescription to women of all ages. Robert Block, MD, FAAP, president of the American Academy of Pediatrics, called HHS’ decision to uphold the age restriction for emergency contraceptives “medically inexplicable.”
“The AAP strongly encourages the use of contraception—including emergency contraception—by adolescents who choose sexual activity,” he wrote in joint statement by the American Academy of Pediatrics, the American College of Obstetricians and Gynecologists, and the Society of Adolescent Health and Medicine.
But many pharmacists share Sebelius’ doubts about whether teens are capable of using emergency contraception safely and appropriately without a professional’s guidance. Among the small number of pharmacists who responded to Pharmacy Times’
request for comment on the issue, most supported limiting access to Plan B:
“It’s already used as a regular form of birth control, which it’s not intended for. Going OTC will only result in further misuse and adverse effects from misuse.”
“It should not be OTC or BTC [behind the counter]. It should require a prescription. It is much stronger than regular contraceptive products, yet those are prescription only. The only reason Plan B is BTC/OTC is purely political. If Plan B is to be OTC, then so should all oral contraceptives.”
“I believe it should be available to minors at the age of consent. But it should still be behind pharmacy counters because it will be stolen so fast and the HIPPA factors will be really dangerous by allowing a teenage cashier to ring it up.”
Other experts—including Kathleen Hill-Besinque, PharmD, MSEd, an assistant dean at the University of Southern California School of Pharmacy—say the drug’s risks are minimal. She told the New York Times
that “very few medications are this simple, convenient, and safe."
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