First Steps Toward Bringing an OTC Pill to Market
International drug manufacturer HRA Pharma is partnering with advocates and experts from Ibis Reproductive Health, a U.S.-based nonprofit research organization for reproductive health, to start the process of bringing an over-the-counter (OTC) oral contraceptive to the U.S. market.
- It may take several years before the FDA actually approves a pill for use without a prescription. However, the first steps of the process are underway.
- Proponents plan to seek FDA approval for a progestin-only pill. Progestin-only pills, which do not contain estrogen, have even fewer contraindications and complications than combined oral contraceptives, making them an excellent candidate for the first OTC birth control pill.
International drug manufacturer HRA Pharma in Paris is partnering with advocates and experts from Ibis Reproductive Health, a Cambridge, MA-based international nonprofit research organization for reproductive health, to start the process of bringing an over-the-counter (OTC) oral contraceptive to the U.S. market.
While it may take several years before the FDA actually approves a pill for use without a prescription, the first steps of the process are underway.
“It’s past time we had an FDA-approved over-the-counter birth control pill, which would give people greater control over their lives and reproductive health regardless [of] their insurance status, age, or access to a clinic, and we’re excited about this progress,” says Britt Wahlin, vice president for development and public affairs at Ibis Reproductive Health. “We’ve built a broad coalition of healthcare providers and activists who are spearheading the effort to move a birth control pill over the counter, and we’ll be working in the next several months and years to educate and raise awareness of the benefits of expanding access to birth control.”
Teens and women in the United States are interested in using an OTC progestin-only pill (POP) if it were available.1 In the first national survey to include teen perspectives and the first to explore interest in using an OTC POP, 39% of adults and 29% of teens reported likely POP use, with higher likelihood of use (46% of adults, 40% of teens) if the pill were fully covered by insurance. The median highest amount women were willing to pay per month was $15 among adults and $10 among teens.1
Support for OTC access has been voiced by medical groups such as the American Academy of Family Physicians and the American College of Obstetricians and Gynecologists. (To see more on the subject, read “Should oral contraceptives move over the counter? Readers speak out” in the February 2016 issue of Contraceptive Technology Update at: http://bit.ly/2cMLmsN.) Ibis convened the OCs (Oral Contraceptives) OTC Working Group, which was formed in 2004 by researchers, advocates, and healthcare providers to work toward moving a pill over the counter to improve access to safe and highly effective contraception.
HRA Pharma and Ibis plan to seek FDA approval for a POP. This medication, which does not contain estrogen, exhibits even fewer contraindications than combined oral contraceptives, making it an excellent candidate for the first OTC birth control pill in the United States. A very small proportion of women present with health conditions that would make use of a POP harmful.2
“We’ll continue to work closely with HRA Pharma to submit the necessary research to the FDA over the course of the approval process,” Wahlin says.
Wahlin notes that a number of states are taking up legislation that would increase access and ensure that all birth control, including OTC methods, is covered by insurance and affordable for more women.
Currently, pharmacists in California, Oregon, and Washington are allowed to prescribe the pill and other hormonal methods, including the birth control patch, the vaginal ring, and/or the shot.
“Medicaid reimburses pharmacists for their prescribing, too, so there is no out-of-pocket cost for those women,” notes Anita Nelson, MD, professor and chair of the obstetrics and gynecology department at Western University of Health Sciences in Pomona, CA. “That is an important issue for OTC pills: Will insurance cover their cost?”
According to the OCs OTC Working Group, U.S. Sens. Joni Ernst, R-IA, and Cory Gardner, R-CO, and Reps. Barbara Comstock, R-VA, and Mia Love, R-UT, have reintroduced the Allowing Greater Access to Safe and Effective Contraception Act in the Senate and the House. This bill, originally introduced in 2015, would push forward the process for FDA review of an application for an OTC OC and provide incentives for manufacturers who are pursuing an OTC switch for an OC product. However, this bill does not address the need for insurance coverage for contraceptives and would provide incentives to manufacturers only if their products are available for women 18 years of age and older.
The OCs OTC Working Group also reports it has yet to learn of any reintroduction of the Affordability Is Access Act, which also was introduced in the House and Senate in 2015. This bill would guarantee insurance coverage of a future OTC OC.3
In state legislative action, New Hampshire lawmakers are considering allowing women 18 years of age or older to obtain pills without a prescription.
Legislation is pending in both the Senate and the House. A House committee recommended the formation of a study commission to consider the proposed policy and questions about protocols and implementation. The Senate bill would allow pharmacies, including mail-order pharmacies, to dispense oral contraceptives without a prescription after an initial consultation with a licensed or certified healthcare provider.4
- Grindlay K, Grossman D. Interest in over-the-counter access to a progestin-only pill among women in the United States. Contraception 2016:94:406.
- OCs OTC Working Group. Moving the birth control pill over the counter in the United States. Fact sheet. July 2015. Available at: http://bit.ly/2lk8VzA. Accessed on Feb. 20, 2017.
- OCs OTC Working Group. OCs OTC bill reintroduced in Congress. OCs OTC Working Group 2017. Jan. 23, 2017. Available at: http://bit.ly/2k2Xebh. Accessed on Feb. 20, 2017.
- Tuohy D. Bill would dispense with prescription requirement for birth control pills. New Hampshire Union Leader, Feb. 2, 2017. Available at: http://bit.ly/2lkhgDs. Accessed on Feb. 20, 2017.
Pharma company partners with nonprofit group to offer contraceptive in the United States.
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