|Senators Joni Ernst (R-IA) and Cory Gardner (R-CO) re-introduced the Allowing Greater Access to Safe and Effective Contraception Act, paving the way for contraceptives to be sold over-the-counter without a prescription. Additionally, Congresswomen Mia Love (R-UT) and Barbara Comstock (R-VA) introduced the companion legislation in the U.S. House of Representatives.
The Allowing Greater Access to Safe and Effective Contraception Act incentivizes manufacturers of routine-use contraceptives to file an application with the Food and Drug Administration (FDA) to sell their products over the counter (OTC). These incentives apply to any contraceptive the FDA deems to be safe and effective for routine OTC use and available to adults over the age of 18. Additionally, the legislation repeals the Affordable Care Act’s restriction on the use of health, medical, and flexible savings accounts to purchase over-the-counter drugs without a prescription.
“The Allowing Greater Access to Safe and Effective Contraception Act is straightforward: it gives women the ability to purchase contraception over-the-counter,” said Senator Ernst. “Women wear many hats in their increasingly busy, daily lives; they should have the ability to access routine use contraception directly from their local pharmacy. This bill provides them with the opportunity to do just that.”
“It’s important that Congress adopt a modern and commonsense approach to contraception,” said Senator Gardner. “Selling safe and effective oral contraceptives over-the-counter to adults will inevitably drive down costs and afford women the convenience to access their medication on their time. Our legislation recognizes the need to make contraceptives affordable and accessible, and it’s time that Congress put politics aside to allow women the ability to make their own decisions about safe, effective, and long-established methods of contraception.”
“American women deserve to have safe, affordable, convenient and effective options for contraceptives available to them without the expense and hassle of government barriers,” said Congresswoman Love. “This bill would provide more options and better access. It’s time to put women in the driver’s seat of their own health care decisions.”
“I join Senators Ernst and Gardner and my House colleague Congresswoman Mia Love (R-UT), in support of legislation to make birth control pills available over-the-counter for adult women,” said Congresswoman Comstock. “Allowing over-the-counter sales of oral contraceptives would enhance women’s access, put decisions in their hands, modernize the health care system, and lower birth control costs. It is a common sense solution that could bring people together and help in ending birth control politics.”
Key provisions of the Allowing Greater Access to Safe and Effective Contraception Act:
· Incentivizes manufacturers of contraceptives to file an application for a prescription-to-over-the-counter switch (Rx-to-OTC switch) by:
o Allowing priority review for contraceptive Rx-to-OTC switch applications.
o Waiving the FDA filing fee for contraceptive Rx-to-OTC switch applications.
· Makes these incentives available to:
o Contraceptives intended for routine-use that, if found to be safe and effective for OTC use by the FDA, would be made available OTC to adults aged 18 and above.
· Allows women greater access and ability to save for their health care needs by:
o Repealing the Affordable Care Act’s (ACA) prohibition on the use of health savings accounts, medical savings accounts, and flexible spending accounts (FSAs) to purchase OTC drugs without a prescription.
o Repealing the ACA’s annual limits on FSA contributions.