All Thumbs Up for OTC Birth Control Pill at FDA Advisory Meeting

In a unanimous vote, advisors to the FDA recommended the agency approve what could become the first-ever over the counter (OTC) birth control pill.

All 17 members of the joint Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive, and Urologic Drugs Advisory Committee said the widespread benefits of switching daily norgestrel tablets 0.075 mg (Opill) to nonprescription status outweigh concerns raised by the FDA.

"The benefits are large, and the drug is incredibly effective," said panel chair Maria Coyle, PharmD, of the Ohio State University in Columbus.

Panelists largely overcame some hesitations about the proposed labeling and whether consumers would understand how to use the product correctly.

"I think it will be effective in the over-the-counter realm," Coyle said, "particularly given that there may be minimal education occurring currently even for prescription users of some of these medications."

Kathryn Curtis, PhD, of the CDC in Atlanta, said the large body of evidence on the effectiveness and safety since the prescription form was approved a half-century ago is "very reassuring."

She pointed out that all of the estimates on failure rates with norgestrel (2-4 per 100 person-years) presented over the course of the 2-day meeting were lower than other OTC birth control products (e.g., condoms, spermicides), and lower than other oral contraceptives in the prescription setting.

And she added that "these pills are safe, with very few contraindications and long-term safety concerns."

Other panelists argued that prescription norgestrel is safer than other common OTC medications such as diphenhydramine (Benadryl) or acetaminophen (Tylenol), which can have serious adverse health effects if taken in excess. Advisors also agreed that a yearly checkup with a doctor to get a birth control prescription is not a huge amount of guidance beyond clear instructions on an OTC drug.

The significance of an OTC birth control pill for populations that have high barriers to getting prescriptions also influenced the committee members. And during the public hearing section, several college students from Texas to Appalachia shared their own experiences trying to access birth control, saying an OTC birth control pill would have been a game-changer for their reproductive autonomy.

"Barriers and access to contraceptives are real and very harmful, and amplified in adolescents," said Elise Berlan, MD, MPH, an adolescent medicine pediatrician at the Ohio State University. "These inequities in access perpetuate inequities in communities for neonatal and obstetric morbidity and mortality, and also unfairly and unjustly distribute the benefits of contraceptive use."

"We should also keep in mind that the health risks of pregnancy, which is the condition that these products aim to prevent, is much greater than the use of any contraceptive product, and this is among the safest of the contraceptive products," Berlan added.

FDA staff raised the prospect that some patients with breast cancer or a history of the malignancy -- where norgestrel is contraindicated due to an increased risk of a recurrence -- might not appropriately avoid the OTC formulation.

But multiple panelists shared that providers are routinely on the lookout to guide breast cancer patients away from harmful drugs and supplements.

Panelist Leslie Walker-Harding, MD, of Seattle Children's Hospital at the University of Washington, pointed out that breast cancer is extremely rare for adolescents, and therefore this group has a low risk profile.

Other concerns raised by the agency included the possibility of people using concomitant products that could interact with or reduce the efficacy of norgestrel tablets, along with the likelihood that the general public, people with limited literacy, and adolescents would correctly and consistently take the pill without guidance from a healthcare professional.

"With the knowledge that adolescents, even young adolescents, make the same decisions that adults make with the medical information given to them, I see no reason to single them out," said Walker-Harding.

While the FDA is not required to follow the recommendations of its advisory committees, it typically does.

Comment