Prescription Drugs

Over-the-Counter Birth Control Bill Launched by Senate Republicans

It would fast-track FDA review of applications to free the pill from prescriptions and let people use health savings accounts for non-Rx drugs.



A new proposal in the U.S. Senate would help federal regulators fast-track the approval process for converting hormonal contraceptive pills from prescription to over-the-counter drug status. Known as the "Allowing Greater Access to Safe and Effective Contraception Act," it was introduced this week by Republican Sens. Joni Ernst (R–Iowa) and Cory Gardner (R–Colo.).

Only the Food and Drug Administration (FDA) can approve the conversion, upon request from a petitioning drug maker. That's why recent movements to "free the pill" in states such as California and Oregon have only been able to dismantle the requirement for a doctor to write the prescription. Now women in these states can theoretically get a prescription on the spot from pharmacists, but it's still not the over-the-counter sales situation that public health bodies recommend.

Congress can't change the status of birth control pills on its own. But the Ernst-Gardner bill would at least speed up the approval process by directing the secretary of Health and Human Services to "give priority review to any supplemental application" submitted "for a contraceptive drug" with respect to routine use. It would also waive the application fee for anyone submitting the application.

French pharmaceutical company HRA Pharma and research group Ibis Reproductive Health announced in late 2016 they were teaming up to "conduct the research needed" to apply for over-the-counter approval of an oral contraceptive pill. "A typical FDA process from the time a drug company begins an application process until a pill is available over the counter is approximately three to five years," Britt Wahlin, vice president for development and public affairs at Ibis, told me last December.

But with priority review possible, that time could be cut down.

The Ernst-Gardner bill also calls for a "repeal of tax on over-the-counter medications." It would accomplish this by allowing funds from health savings accounts to be used for the purchase of not just prescription drugs but over-the-counter medications, too.

Lastly, it would repeal limitations on contributions to flexible spending accounts.