05.21.15

Ayotte, Gardner Introduce Bill Aimed at Increasing Availability of Safe and Effective Over-the-Counter Contraceptives

Washington, DC – U.S. Senators Kelly Ayotte (R-NH) and Cory Gardner (R-CO) announced today that they have introduced legislation that 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).

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.

“Our legislation will help increase women’s access to safe and effective contraceptives and further empower women to make their own health care decisions,” said Ayotte. “In addition, our bill restores the ability of Health Savings Accounts and Flexible Spending Accounts to be used to purchase over-the-counter medications, giving women more purchasing power.”

“It’s time to allow women the ability to make their own decisions about safe, effective, and long-established methods of contraception,” Gardner said. “Most other drugs with such a long history of safe and routine use are available for purchase over the counter, and contraception should join them. Making this medication available over the counter would increase access in rural and underserved areas, save consumers money by increasing competition and availability, and save women time by increasing the ease of getting the safe contraception they need.”

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 being cosponsored by Senators Dean Heller (R-NV), Joni Ernst (R-IA), Richard Burr (R-NC), Ron Johnson (R-WI), and Thom Tillis (R-NC).

KEY PROVISIONS:

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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