Darian Rodriguez

CADENCE OTC: REVOLUTIONIZING ACCESS TO REPRODUCTIVE HEALTH AND JUSTICE

Darian Rodriguez Heyman

Cadence OTC: Revolutionizing Access to Reproductive Health and Justice

Cadence Health, a small, California-based, public benefit start-up, acquired original product rights to two popular and well-established birth control pill formulations in 2016 and have been quietly working behind the scenes with the FDA on the long process of OTC approval.

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Many people are curious why the birth control pill, the most commonly used form of reversible contraception for more than 50 years, is still only available by prescription in the USA. The main reason is that there is a widely held belief that birth control pill use requires medical supervision to be safe. The other reason is that no owner of an original patented* pill formulation has ever attempted to obtain such permission/approval from the FDA, until now.

There are many reasons why the timing may be right. We now have more than 50 years experience with the birth control pill and know more about the complications and side effects of this medication than most, and this product is one of the most extensively researched drugs in history. We have also learned from this research that by providing a simple checklist most women can determine whether this product is safe for them to use, or not, without medical supervision. This would make it eligible for sale over the counter (OTC) if the FDA approves the new labeling and if the label tests well with consumers.

Over the past decade, there has been growing scientific and medical support for OTC approval. Major medical consensus groups in the US have endorsed moving the pill OTC. These include the nations gynecologists, internists and family practitioners; the American College of Obstetricians and Gynecologists (ACOG), the American Medical Association, and the American Academy of Family Physicians (AAFP), as well as the American College of Clinical Pharmacy (ACCP), and the Association of Reproductive Health Professionals.

But there is also a public health benefit that we only recently began to appreciate. Despite the availability of prescription oral contraception, just less than half of all pregnancies (46%) conceived in the USA each year are unintended. Evidence suggests that access to health insurance or health insurance that covers contraception, leaves many people without access that guarantees continuous availability without breaks. And even for those with insurance the additional barriers of getting an appointment with a doctor, or taking time to go to a pharmacy, and the cost are large contributors to the gaps in coverage that lead to accidental pregnancies. The most egregious are the contraceptive deserts where access simply is elusive.

Cadence Health, a small, California-based, public benefit start-up, acquired original product rights to two popular and well-established birth control pill formulations in 2016 and have been quietly working behind the scenes with the FDA on the long process of OTC approval. The team includes leading medical, public health, regulatory, and manufacturing experts with deep understanding of contraceptive manufacturing and marketing took on the mission to provide affordable, equitable access to these oral contraceptives and are working closely with the FDA to develop labeling that will achieve that approval. Their investors include social impact investors, foundations, and family offices that support OTC access to birth control. Opening up access to the oral contraceptive pill to consumers in the same way that Tylenol or Claritin is available is predicted to make it much easier for users already using the Pill and effectively dismantle the barriers to the millions of potential users who want to use a more reliable method than the next most popular OTC contraceptive, the condom.

*technically the original rights to an FDA-approved drug formulation (NDA)

Addenda

While making a birth control pill available OTC would add an important option for access and continuous use, it does not change the availability of other prescription birth control pill formulations available today. An OTC option would bring access to the millions of potential users who do not have health insurance and the many more millions who have interruptions in their health care coverage or delays in obtaining refills.
Cadence’s birth control pill products are already FDA approved, safe and effective oral contraceptive formulations available by prescription in the USA and worldwide.