Federal Bill Aims to Speed OTC Birth Control Efforts


by Allison Gilchrist

Source Pharmacy Times

A new federal bill would compel the FDA to review contraceptive drug applications more quickly and make them available OTC.

The Over-the-Counter Contraceptives Act (HR 5138) was referred to both the House Committee on Ways and Means and the Committee on Energy and Commerce in late April.

Under the act, the FDA would be required to grant a 6-month priority review to supplemental applications for contraceptives and, if approved, make them available without a prescription to all women aged 18 years and older. However, the current text of the bill doesn’t specify whether the act would apply to all contraceptives or only to oral formulations.

The concept of allowing contraceptives to be sold OTC nationally has wide-scale support. A May 2015 survey by Ibis Reproductive Health found that more than 50% of respondents, including health care providers and academic researchers, were “strongly in favor” of OTC birth control, while 86% were either “strongly in favor” or “somewhat in favor.”

In terms of costs, the National Center for Policy Analysis previously argued that transitioning birth control to OTC would lower prices precipitously and result in dramatic savings, similarly to when proton pump inhibitors made the jump from prescription-only to OTC. Additionally, estimates from the Consumer Healthcare Products Association suggest that consumers save between $6 and $7 in prescription costs in unnecessary physician visits for every $1 spent on an OTC product.

However, the Guttmacher Institute, a research organization focused on women’s health, asserted that age restrictions like the one seen in HR 5138 are just additional means of restricting access to birth control.

“Many experts fear that in response to conservative demands, the FDA or other policymakers might impose an age restriction on an [OTC] product, which would limit access for adolescent and young women. These age-groups face a greater risk of unintended pregnancy and more barriers to accessing contraceptives than older women, and therefore have the most to gain from an OTC switch,” the group argued in a policy paper.

HR 5138 is just the latest in a serious of legislative developments to expand birth control access.

Presently, pharmacists in California and Oregon have full authority to prescribe hormonal contraception such as the pill, patch, ring, and shot. New Jersey, Tennessee, Washington, and several other states are currently considering similar legislation.

Meanwhile, a first-of-its-kind law in Maryland now requires health insurers to completely cover the cost of emergency contraception.

Relatedly, HR 5138 also would repeal section 9003 of the Affordable Care Act, which requires patients to present a prescription in order to be reimbursed for certain OTC medications through flexible spending accounts and health reimbursement arrangements.

Original Article