Speeding Up FDA Reviews for Over-the-Counter Contraceptives (H.R. 421)
Do you support or oppose this bill?
What is H.R. 421?
(Updated May 6, 2020)
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Provisions in the Affordable Care Act (ACA) would be repealed so that health savings accounts and health flexible spending accounts can be used to pay for medicine without a prescription.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. 421
A CBO cost estimate is unavailable.
Additional Info
In-Depth: Sponsoring Rep. Mia Love (R-UT) introduced this bill during the 114th Congressto “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.
The current version of this legislation has the support of four cosponsors in the House, all of whom are Republicans.
Media:
- Sponsoring Rep. Mia Love (R-UT) Press Release (Previous Version)
- Regulatory Affairs Professional Society (Previous Version)
- The National Campaign (Previous Version)
(Photo Credit: Ceridwen / Creative Commons)
The Latest
-
How To Help Civilians in UkraineHeavy shelling and fighting have caused widespread death, destruction of homes and businesses, and severely damaged read more... Public Safety
-
The Latest: Israel Evacuates Rafah, Palestinian Place of RefugeUpdated May 6, 2024, 12:00 p.m. EST The Israeli military is telling residents of Gaza who have sought shelter in Rafah to read more... Israel
-
Trump Hush Money Trial Enters Third Week, Strategy to ‘Deny, Deny, Deny’Updated May 6, 2024, 11:00 a.m. EST The criminal trial to determine whether Trump is guilty of falsifying records to cover up a read more... Law Enforcement
-
IT: Battles between students and police intensify, and... 💻 Should we regulate AI access to our private data?Welcome to Thursday, May 2nd, listeners... The battle between protesters and police intensifies on college campuses across the read more...