Handouts

 

The Pill Over the Counter: Increasing Access

People may soon have another accessible option for preventing pregnancy - the contraceptive pill being available on pharmacy shelves, without a prescription. This major breakthrough is nearing its final stages of FDA approval.

Another Safe Over-the-Counter Contraceptive Option

  • People may soon have another accessible option for preventing pregnancy.

  • The FDA will have the opportunity to approve access to birth control pills without a prescription.

  • The pill has a 60 year safety record, with decades of research about its safety. 

Widespread Support for Over-the-Counter Access

  • Major medical associations have studied the evidence and support the effort to achieve over-the-counter access. 

  • A large majority — 70% — of reproductive-aged women support making the contraceptive pill available over the counter without a prescription.

Reducing Barriers

  • People who may benefit the most from the pill on-the-shelf are those in rural areas, people who can’t afford doctor visits, hourly workers who cannot easily get time off of work, people in between insurance plans, and those who want a more convenient option.

  • An affordable pill over-the-counter without restrictions would make it easier for people to physically and logistically access birth control in their communities.

  • Access to safe and effective birth control over the counter will reduce unintended pregnancies.

  • The contraceptive pill is the most common form of reversible contraception in the United States.

  • One in three women currently using a less effective birth control method report they would start using the pill if it were available over the counter.

The Pill Over the Counter: A Safe Option

Increasing Access

Soon, people may have more kinds of birth control options over the counter on pharmacy shelves. 

The FDA has set a path forward to bring oral contraception over the counter.  Two pharmaceutical companies are in the final stages of approval, which could occur within the next few years.

Over-the-counter safety

The pill has a 50+-year safety record.  It is not toxic, not addictive and has no risk of overdose, thus meeting the FDA criteria for OTC access.  Other OTC drugs carry more serious risks, such as NSAIDs, Sudafed, Tylenol, antihistamines, and diet pills.

  • Research has shown that people can accurately identify if the pill is a safe option for them. These facts are consistent with over-the-counter safety standards.

  • The pill meets over-the-counter health criteria.  The risks associated with hormonal birth control (i.e., VTE) are very small compared with the risks of unintended pregnancy.

  • Major medical groups — including ACOG and American Academy of Pediatrics — have urged the FDA to consider making the pill over-the-counter available to all ages. 

Reducing Unintended Pregnancy

Increasing access by making the pill available over the counter would make it easier for people to physically and logistically access birth control in their communities.

Almost half of pregnancies in the U.S. are unintended. Modeling suggests that removing financial and prescription barriers could reduce unintended pregnancies in the U.S. by up to 25 percent.

Eighty percent of the global population already has access to the pill over the counter. Some countries such as the U.K. and the U.S. have been expanding access via pharmacists and the U.S. may soon consider full over-the-counter status.

Medical Endorsements

“Providing patients with OTC access to the birth control pill is an easy call from a public health perspective as the health risks of pregnancy vastly outweigh those of oral contraceptive use.”  

- AMA Board Member David Aizuss, M.D

Questions for the FDA Commissioner Nominee: Women’s Health

The next FDA commissioner will play a pivotal leadership role in addressing health inequities, advancing science and increasing access to the healthcare that women are seeking.

The FDA commissioner nominee must address three questions:

  1. Access
    How will you ensure that access to medications and devices that have been proven to be safe for people capable of reproduction are not stymied due to undue political influence?  For example, will the upcoming FDA approval process for over-the-counter access to the contraceptive pill be evidence-based and conducted in a timely manner?
    Background: Women’s medications have been stymied in the FDA process by social bias and political interference, such as the major delay in over-the-counter approval of emergency contraception. Soon the FDA may rule on applications for oral contraception over-the-counter. Major medical groups have endorsed the prospect of over-the-counter access to the contraceptive pill and studies show it is safe and effective. 70% of women of reproductive age favor being able to access the pill on the store shelf.

  2. Equity
    What is your definition of health equity and, if confirmed, what role will the FDA—and you, as commissioner— play in achieving health equity?
    Background: Women often encounter disparate treatment regarding reproductive health care. For example, the FDA has subjected mifepristone to outdated medically unnecessary restrictions for over 20 years that obstruct timely access to essential, sensitive health care for pregnant women.  

  3. Inclusion
    How will the FDA improve and modernize drug and medical device trials—including equitable inclusion of people of color and women?
    Background: Historically women of reproductive age were often excluded or underrepresented in clinical trials (e.g., diabetes, heart disease). This impedes the ability of women and health care providers to make safe, informed decisions--resulting in lower quality and less access to healthcare. The problem persists.