Published July 22, 2022
On the heels of last month’s Supreme Court Dobbs v. Jackson Women’s Health Organization, returning abortion policies back to individual states, Perrigo, an Ireland-based subsidiary of Allergan just applied to the FDA to for “over-the-counter” status for its oral contraceptives. This is a fool’s errand and a potential hazard for women’s health.
Existing clinical practice standards necessitate a number of important checks before a medical provider prescribes oral contraceptive therapy. Periodic provider visits and follow-ups are critical for achieving the appropriate dose and along with monitoring routine women’s health needs. Likewise in the late 1990s, it was shown that men visiting their prescribers for Viagra for erectile dysfunction was credited with an uptick in early diagnosing of non-erectile related health issues such as atherosclerosis, hypertension, and cancer.
It’s important to keep in mind that while many over-the-counter products exist, oral contraceptives may be made up of progesterone, with or without estrogen. These are not drugs, but synthetically produced hormones. Hormones are especially effective, potent, and far-reaching in their effect because they mirror chemical signals from the endocrine system and brain.
No other over-the-counter products contain hormones. Over-the-counter drugs are meant for the temporary, short-term relief of symptoms whereas oral contraceptives are meant as a chronic, long-term medicine that may very well be taken for decades.
Under current guidelines, the following critical prescriber assessments represent the standard of care for initiating or refilling oral contraceptive prescriptions in order to maintain America’s existing high public health standards. Should oral contraceptives be obtained without a prescription from a medical provider, these assessments will likely be overlooked.
The standard of care prior to prescribing oral contraception is to check blood pressure before beginning birth control pills. Hormones found in birth control pills can sometimes cause your blood pressure to rise. In extreme cases, the pills can cause secondary hypertension. High blood pressure is a very common disorder in the United States. An estimated 30 to 40 percent of Americans have high blood pressure, and this number is only increasing with rising levels of obesity.
Smoking and potentially even “vaping” is a high-risk factor when taking contraceptive pills. The risk of having a stroke, blood clot, or heart attack increases when a patient smokes and takes an oral contraceptive. Providers know to recommend alternatives to oral contraceptives for patients who use nicotine or have any other risk factor or family history related to smoking.
Family or Personal History of Blood Clots
Patients at risk for blood clots are also in the high-risk bracket when using oral contraceptives. The birth control pill is known to increase the possibility of blood clots. The hormones estrogen and progestin found in many oral contraceptives cause an increase in clotting factors. Doctors, therefore, have to check for a history of blood clotting as part of the birth control pill examination. Patients that are susceptible to blood clots in the past or are prone to blood clots, should choose a suitable alternate contraceptive.
Breast Cancer Screening
Studies from the National Cancer Institute have shown that contraceptives contain progesterone and estrogen either of which have the ability to increase the risk for or exacerbate existing breast cancer. Patients need to obtain breast screenings prior to taking contraceptive pills to detect early disease since progesterone or estrogen can potentially exacerbate underlying cancer.
Studies from the University of Houston have shown that contraceptives containing either progesterone or estrogen have the ability to increase the risk for or exacerbate existing cervical cancer. A pap smear using a brush of cells from the cervix is used to check for cervical cancer. These tests are also important for patients to receive once a year so that if cervical cancer does develop, it can be detected and treated early.
Alternatives or reversible options such as an IUD or subcutaneous implants as alternatives to oral contraceptives will also likely be considered during a prescription consultation, ensuring the woman is informed about all her options and can make the best choice for her in consultation with her provider.
Making contraceptives over the counter could lead to increases in morbidity and mortality in the forms of stroke, heart disease, blood clots, and cancer. Additionally, birth control interactions with existing over-the-counter and prescription drugs could lead to an increased incidence of unexpected pregnancies.
Oral contraceptives in particular ought to remain as prescription items, and allowing their over-the-counter access would be a barrier to well-patient visits and preventative medicine testing, something that even Planned Parenthood has loudly advocated for over many decades in fundraising plus on its own website.
The FDA should reject Perrigo’s request, but anyone who has followed the Biden White House FDA knows they more than likely going to approve it for political reasons. Under Biden, the FDA seems to ignore drug safety data as a matter of standard routine. Unfortunately, an FDA approval will debase the historical standard of monitoring women’s health and fertility.
David Gortler, Pharm.D. FCCP is a Fellow at the Ethics and Public Policy Center whose work focuses on FDA oversight and accountability. Dr. Gortler is a pharmacologist and pharmacist and a Yale-trained bench research scientist in molecular biology with a subspecialty in the field of vascular medicine. He was a professor of pharmacology and biotechnology at the Yale University School of Medicine, where he also served at Yale’s Center for Bioethics, and was an FDA Medical Officer who was later appointed by the White House to serve on the FDA’s Senior Executive Leadership Team as senior advisor to the FDA Commissioner.