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(Washington, DC) – United States Senator Dean Heller issued the following statement after becoming an original cosponsor of the Allowing Greater Access to Safe and Effective Contraception Act. The legislation, introduced by Senators Kelly Ayotte (R-NH) and Cory Gardner (R-CO), would help increase access to safe and effective contraceptives by encouraging manufacturers of routine-use contraceptives to file an application with the Food and Drug Administration (FDA) to sell their products over the counter (OTC).

“As a husband and father of two daughters, I don’t believe women should be restricted in their access to health care. That’s why I am pleased to join Senators Ayotte and Gardner in support of this legislation. Women should have greater access to safe, effective, and affordable contraception. Allowing routinely-used contraceptives to be available over-the-counter gives female patients more control over their health care decisions. And, that’s the way it should be,” said Senator Dean Heller.   

The Allowing Greater Access to Safe and Effective Contraception Act would incentivize manufacturers of routine-use contraceptives to file for a prescription-to-over-the-counter switch by allowing for priority review of the application and waiving the FDA filing fee. These incentives would be available for any contraceptive available to adults aged 18 and above and which was found by the FDA to be safe and effective for routine OTC use.

Further, the bill would repeal 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 FDA has found a number of contraceptives to be proven safe and effective at preventing pregnancies and managing certain health conditions. However, in order to access safe and effective contraceptives designed for routine use, currently a woman must visit her health care provider to receive a prescription. The Allowing Greater Access to Safe and Effective Contraception Act would encourage manufacturers of routine-use contraceptives to file an application with the FDA to switch their products from prescription to OTC. This legislation would not interfere with the FDA's current process for determining safety and efficacy, maintaining FDA scientists' and experts' authority to make the final decision on whether a contraceptive should be made available OTC. The bill is also cosponsored by Senators Joni Ernst (R-IA), Richard Burr (R-NC), Ron Johnson (R-WI), and Thom Tillis (R-NC).

KEY PROVISIONS OF THE LEGISLATION:

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
    • Allowing priority review for contraceptive Rx-to-OTC switch applications
    • Waiving the FDA filing fee for contraceptive Rx-to-OTC switch applications
  • Makes these incentives available to
    • 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 ability to save and make their own health care decisions by
    • 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
    • Repealing the ACA’s annual limits on FSA contributions

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