FAQs

Which version of the Pill is Cadence Health seeking to take over-the-counter?

Cadence Health owns the exclusive rights to Lo/Ovral and Alesse. Both of these products are oral contraceptive tablets that contain estrogen and progesterone. Millions of women have safely used both products for more than 2 decades. When approved by the FDA, they can be bought without a doctor’s prescription.

What is the difference between Lo/Ovral and Alesse?

Both products contain the same active ingredients at slightly different doses. Both options safely and effectively prevent pregnancy when used as directed.

Is the Pill available over-the-counter today?

Not in the US – not yet. Cadence Health is the first health care company seeking to obtain OTC status for a combined oral contraceptive in the US.

Why should the Pill be available over-the-counter?

Many women who see their doctors regularly would still benefit from the convenience of OTC access for refills or lost Pills. Also, having a regular insurance or a health care provider is not an option for many women. It is important that women have access to safe and effective oral contraceptives whether or not they have a regular health care provider.

Millions of women do not have continuous health insurance or a regular health care provider and face significant obstacles getting access to the Pill. An OTC Pill will add an option for women who face these obstacles. It will create a level playing field for women who do not have health insurance or contraceptive coverage in their health insurance plans.

Why is the Pill not available over-the-counter?

The U.S. Food and Drug Administration (FDA) decides whether any product, including contraceptives, can be made available without a prescription. Before Cadence Health, no other pharmaceutical company had applied to switch the birth control pill to OTC status.

Is it safe for a woman to take the birth control Pill?

The Pill has been used safely by more than 20 million women in the US over decades. It is safe for most women.

Citations:

  • Mortality among contraceptive pill users: cohort evidence from Royal College of General Practitioners’ Oral Contraception Study
  • Oral contraceptive use and cancer: final report from the Oxford–Family Planning Association contraceptive study
  • Oral Contraceptive Pills as Primary Prevention for Ovarian Cancer
  • Oral contraceptive use and risk of breast cancer: A meta-analysis of prospective cohort studies
  • Unintended Pregnancy in the United States
  • Hormonal Contraception
  • Should Oral Contraceptives Be Available without Prescription
  • Past oral contraceptive use and self-reported high blood pressure in postmenopausal women
  • An overview of oral contraceptives
  • Thrombotic risks of oral contraceptives
  • States Lead Effort to Let Pharmacists Prescribe Birth Control
  • Accuracy of Self-Screening for Contraindications to Combined Oral Contraceptive Use
  • Interest in over-the-counter access to oral contraceptives among women in the United States
  • A Survey of Teenagers’ Attitudes Toward Moving Oral Contraceptives
  • Over-the-Counter Access to Oral Contraceptives
  • Over-the-Counter Oral Contraceptives
  • D-75.995 Over-the-Counter Access to Oral Contraceptives
  • Changing Oral Contraceptives from Prescription to Over-the-Counter Status: An Opinion Statement of the Women’s Health Practice and Research Network of the American College of Clinical Pharmacy
  • Maternal use of oral contraceptives and risk of birth defects in Denmark: prospective, nationwide cohort study
  • Unintended Pregnancy in the United States
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