Speeding Up FDA Reviews for Over-the-Counter Contraceptives (H.R. 5138)

What is H.R. 5138?

(Updated July 19, 2017)

This bill would require the Food and Drug Administration (FDA) to prioritize review of over-the-counter contraceptives that would be available to individuals age 18 or older without a prescription. It would apply to supplemental drug applications, which are used to change the approved use of a drug.

The FDA would also waive user fees for related supplemental drug applications, and any drug that’s eligible for priority review must be available as a prescription drug for individuals under age 18.

Provisions in the Affordable Care Act (ACA) would be repealed so that health savings accounts and health flexible spending accounts can be used to pay for medicine without a prescription. Additionally, the limit on salary reduction contributions under a cafeteria plan would be eliminated. Both reforms would be effective as if the provisions had never been enacted in the first place.

Argument in favor

The FDA should prioritize these applications so that more safe, affordable contraception can be available to consumers over-the-counter without the need for a prescription.

Argument opposed

The FDA shouldn’t prioritize applications for contraceptives that would be available over-the-counter over more critical medications that have fewer alternatives.

Impact

Individuals over age 18 who would like to buy a contraceptive over-the-counter and under age 18 who would get them as prescription drugs; and the FDA.

Cost of H.R. 5138

A CBO cost estimate is unavailable.

Additional Info

In-Depth: Sponsoring Rep. Mia Love (R-UT) introduced this bill to “incentivize contraceptive manufacturers to apply to make their routine use contraceptives over-the-counter for women 18 and older by waiving the filing fee they would normally pay.” She says that “we have a “plan B” over-the-counter, but we don’t have a plan A” and her bill would expand access to contraceptives so that plan B emergency contraception isn’t required as often.

This legislation has the support of six cosponsors in the House, all of whom are Republicans.

Media:

• Sponsoring Rep. Mia Love (R-UT) Press Release
• Regulatory Affairs Professional Society
• The National Campaign