Published June 9, 2023
On the heels of the Dobbs decision returning abortion policies to the democratic process, Biden’s FDA is proposing to eliminate the prescription requirement for oral contraceptives and make them available over-the-counter (OTC). This proposal is driven more by politics than science, and risks the potential to inflict serious health harms on women and girls.
Historical Standards for OTC Approval
Unlike most drugs, oral contraceptives are especially powerful physiologically because they are hormones (not simply a drug). Administered hormones mirror natural chemical signals from one’s own endocrine system and brain. The oral contraceptive drug proposed for OTC distribution contains synthetic progestins which mimic endogenous progesterone activity but have additional pharmacological effects.
Modern OTC approvals typically have overwhelmingly positive safety records and are generally (but not always) meant for the temporary, short-term relief of symptoms or conditions. Think Ben-Gay, simethicone, bisacodyl, Chloraseptic and Neosporin. They are typically self-administered and the few safety concerns are contained in the labels and inserts, usually in tiny print.
In contrast, oral contraceptives are meant as a long-term hormonal product taken daily – potentially for years or decades – and have been directly correlated with serious medical risks that require oversight by a licensed prescriber. Indeed, no prescription-grade hormone has ever been proposed as a long-term daily OTC product.
The list of progestin-associated risks is extensive, and according to Medline includes weight gain, migraine headaches, excessive bleeding, depression, acne, hirsutism (unwanted hair growth), and loss of vision. Other medical risks are cancer, psychiatric, and STD-related.
If the FDA makes oral contraceptives available without a prescription, clinicians will be excluded from warning, monitoring or evaluating patients about these risks.
Breast Cancer Screenings
Breast cancer is currently the most common non-cutaneous cancer worldwide — surpassing lung cancer for the first time in 2020 — and is already the second leading cause of cancer death in American women. Studies from the National Cancer Institute have shown that long-term use of progestins may increase the risk and/or exacerbate existing breast cancer. Why wasn’t the FDA advisory committee concerned with potentially aggravating already worrisome epidemiology with OTC oral contraceptives? Every prescription refill appointment serves as a medical visit where clinicians can conduct exams, order mammograms, and make other medical assessments.
Cervical Cancers and STDs
A pap smear (an examination of cells from the cervix) and a physical exam are vital for discovering cervical cancer and sexually transmitted diseases. Studies from the University of Houston have shown that contraceptives containing progestins have the ability to increase the risk for, or worsen existing cervical cancer. Other studies show that women who have used oral contraceptives over five years have as much as a 60 percent higher risk of cervical cancer than women who have never used them, according to the National Cancer Institute, based on a 2003 publication from The International Agency for Research on Cancer in France involving 12,531 patients.
Pap smears are taken regularly when patients visit their OB-GYNs for oral contraceptive prescriptions or refills and if abnormal findings are detected immediate action can be taken. There are already more than 20 million estimated new STD cases reported each year in the USA. According to the Centers for Disease Control and Prevention, HPV (human papilloma virus)is the most common STD in the United States and is silently spread by sexual contact, with symptoms not emerging until later. HPV can progress into cervical cancer. HPV, like other viral STDs such as herpes and HIV, do not have pharmacological cures.
Progesterone Use is Associated with Depression and Mood Disorders
Mood and anxiety disorders are vastly overrepresented in women, with major depressive disorder and most anxiety disorders twice as common in women as in men. One important contributor to these differences could potentially be the administration of progestin in OTC oral contraceptives.
There is evidence showing that progesterone administration can lead to depression and other negative mood symptoms. Progesterone products can also worsen existing mood symptoms. When investigators looked at the effects of estrogen alone versus combined treatment with estrogens and progesterone on mood, some found a beneficial effect.
However, when studies separate out the effect of progesterone without estrogen, a negative effect on mood is observed. This is an important distinction because unlike most oral contraceptives, the proposed OTC product is progestin-only. In fact, a 2022 study stated that “one of the most common reasons given for [a prescriber’s] discontinuation of oral contraception is changes in mood or an increase in depressive symptoms.”
To that end: Does the FDA really expect young girls and women using OTC oral contraceptives to potentially self-monitor multiple kinds of cancer, STDs, psychological changes, and other serious adverse effects while using this product?
Endangering Children and Disempowering Parents
Aside from direct health consequences, policymakers must consider potential unintended consequences. If oral contraceptives are made available to everyone at any time, this would include minor children, sex traffickers, and sex abusers.
Despite these clear hazards, a spokeswoman representing the American College of Gynecology (ACOG) went on record in a briefing regarding the FDA advisory committee meeting to not only promote OTC oral contraceptives, but additionally to echo its official website recommendation advocating “…over-the-counter access to (oral) hormonal contraception without age restrictions” (emphasis added)
Does the FDA agree with ACOG? Will they support OTC oral contraceptive distribution “without age restriction?” Will they allow OTC sales to include vending machines, as is done for Plan B where they would putatively be placed in America’s public high schools?
…What about public middle schools?
…What about public elementary schools?
It quickly becomes problematic because kids have limited understanding of microbiology, the signs or symptoms of STDs or the permanence or lethality of some STDs. Simultaneously, having widespread availability of OTC oral contraceptives in targeted smartphone and online advertisements would more than likely encourage more and riskier sexual behavior among youth.
Additionally, because oral contraceptives require careful and disciplined compliance to be effective in preventing pregnancy, America’s youth pregnancy rate could actually increase due to non-medically supervised administration.
Promoting Sexual “Autonomy” for Children?
Making oral contraceptives OTC not only cuts clinicians out of the picture, but parents of minor children as well. Parents are the best protectors of our children’s physical, moral, and psychological well-being and have the right to know if their minor kids are taking these drugs so they can better protect them. Of note, existing Plan B emergency contraception vending machines accept cash or credit cards which deceptively show charges as “vending and snacks” on mailed statements. The same could certainly occur with OTC oral contraceptive pills.
Meanwhile, advocates for OTC oral contraceptives like ACOG prefer to focus on eliminating every clinical or regulatory checksum in an exuberant rush to remove perceived “barriers” in order to endorse “sexual independence and autonomy of minors.” I wonder how most parents would feel about their children having “sexual independence.”
Risks Outweigh Benefits
Existing data indicates that making oral contraceptives available OTC could lead to a deluge of negative public health outcomes. Additionally, oral contraceptive interactions with existing prescription drugs could lead to an increased incidence of unexpected pregnancies and serious adverse events in mothers, babies, and kids.
There are other important hormonal alterations hypothetically associated with oral contraceptive use in women needing further research, in addition to effects on a developing fetus when administration continues during early pregnancy (when girls or women continue taking pills because they don’t realize they are already pregnant).
Historical Standards and FDA’s Mission
Oral contraceptives have been prescription-only for over seven decades, and for good reason. In this case, the FDA’s role is to make data-driven decisions based on public health and drug safety, not address social concerns, a child’s “sexual independence and autonomy” or perceived “barriers” to access to “reproductive health.” The burden is on the FDA to assert beyond doubt that something has been fundamentally established with respect to oral contraceptives being safe enough to be used OTC.
During the advisory committee’s discussion, panelists acknowledged some of the limitations of the data but ultimately concluded that enough evidence exists that show that benefits of having an over-the-counter contraceptive pill outweighs risks. One FDA committee member was quoted saying:
“Do I think that we’ve got perfect data? No. Do I think it was a perfect study? No. Do I think it was adequate to feel [emphasis added] reassured that a large number of people can use this drug as intended? Yes.”
Of course, that is not the way the FDA or any public health scientist is supposed to think. It should wait for proven, conclusive evidence and consider the full spectrum of risks and benefits as their primary objective, instead of relying on how they “feel.” Furthermore, just “us[ing] the drug as intended” is not the only matter needing consideration. Especially because FDA panelists acknowledged an important shortcoming of the submitted data by the sponsor, who obviously has a financial stake in the matter. While no study is ever “perfect” it is unclear if any of the above-mentioned dangers were considered or if the FDA panelists just relied on what the sponsor provided or did their own independent research.
It’s illustrative how these FDA advisory committee members justified their decision. Under normal circumstances, any one of the above mentioned adverse events or public health risks would be compelling enough to give cause for committee rejection – or at least a non-unanimous recommendation. …Then again, it’s the FDA that selects its own outside advisory committee members.
An OTC oral contraceptive approval would be another example of America’s public health agencies and advisors placing subjective, non-FDA priorities above what should be hard, validated scientific evidence of safety and public health benefit. Unfortunately, today there are too many examples of that at America’s federal agencies, especially when it came to expedited mRNA product approvals, lockdowns plus various mandates, on top of a host of recent, misguided, non-covid FDA drug approvals and HHS’s advocacy of transgenderism in children. It’s so scandalous that even the British Medical Journal is publishing pieces from ex-FDA scientists mocking other, recent, unscientific FDA decisions and approvals.
Anyone who has followed the FDA knows that under Biden, many (but not all) FDA divisions have become pliant regarding its “safe and effective” standards. Unfortunately, Biden’s FDA would be responsible for the potential deluge of negative outcomes if oral contraceptives become OTC.
Based on medical and epidemiological risks, oral contraceptives should remain prescription-only. Requiring professional medical screenings, follow-up visits, education, tests, and examinations are not “barriers” to good health in women and girls, but the best protection. With the case so clear for the status quo, will the FDA commissioner make access or patient safety his ultimate priority?
We will know that answer very soon.
Dr. David Gortler, a 2023 Brownstone Fellow, is a pharmacologist, pharmacist, research scientist and a former member of the FDA Senior Executive Leadership Team who served as senior advisor to the FDA Commissioner on matters of: FDA regulatory affairs, drug safety and FDA science policy. He is a former Yale University and Georgetown University didactic professor of pharmacology and biotechnology, with over a decade of academic pedagogy and bench research, as part of his nearly two decades of experience in drug development. He also serves as a scholar at the Ethics and Public Policy Center