Jeffrey A. Singer The New York Times reports today that two small oral contraceptive makers, Cadence and HRA Pharma, have been seeking to make their birth control pills over‐the‐counter since 2016. The Food and Drug Administration has taken five years “dialoguing” with the pharmaceutical firms but has yet to give them “clearance” to formally apply ...
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The New York Times reports today that two small oral contraceptive makers, Cadence and HRA Pharma, have been seeking to make their birth control pills over‐the‐counter since 2016. The Food and Drug Administration has taken five years “dialoguing” with the pharmaceutical firms but has yet to give them “clearance” to formally apply for the switch. The Times article cites an FDA spokesperson as saying the agency hopes to reach a decision within 10 months of the companies submitting a formal application.
As I have written here, birth control pills are available over‐the‐counter in over 102 countries. That includes countries like communist China and Cuba. The U.S. joins Saudi Arabia and most Western European countries in denying women access to birth control pills without a permission slip from another autonomous adult, i.e., a licensed health care practitioner.
This is not the first time the FDA has blocked or delayed access to safe and necessary drugs. These drugs range from non‐steroidal anti‐inflammatory agents like ibuprofen to non‐sedating antihistamines like Claritin (safer than over‐the‐counter alternatives like Benadryl).
The FDA has been infringing on the fundamental and sacred right to self‐medicate since at least 1951, when the Durham‐Humphrey Amendment to the Food, Drug, and Cosmetic Act of 1938 was enacted. Prior to that time, the manufacturers could decide whether their drug should be sold over‐the‐counter or prescription‐only. They would base their decisions on the complexity of the drug, the likelihood of adverse reactions, and the risk of liability. Sadly, that decision became centered in a government monopoly agency which unavoidably adds the precautionary principle, politics, and special interest pleading into the mix. Michael Cannon and I dive into this in great detail in our October 2020 white paper, “Drug Reformation: End Government’s Power to Require Prescriptions.”
In our white paper we offer several reform proposals, including intermediate ones. One intermediate proposal is for Congress to adopt a rule that would automatically assign over‐the‐counter status to drugs that are OTC in a group of designated countries. Returning to the antihistamine example, Claritin was available over the counter in Western Europe several years ahead of the U.S. Statin drugs and asthma inhalers are OTC in the UK today, as is insulin in Canada. The opioid overdose antidote naloxone is OTC in Australia, Italy, and France, but is still prescription‐only in the U.S. (Many states have come up with workarounds to this by having their state health directors, if they are licensed physicians, issue “standing orders” for naloxone.)
For more than a decade the American College of Obstetrics and Gynecology and the American Academy of Family Physicians has called on the FDA to make birth control pills available over‐the‐counter. Research shows making contraceptives over‐the‐counter leads to improved continuation. Research also shows women are quite diligent when they self‐screen for oral contraceptives. Physicians concur with 90 percent of their assessments, while the women are more conservative than the doctors for the remaining 10 percent.
Michael Cannon and I have pointed out that switching from prescription to over‐the‐counter usually causes the price of the drug to fall. Thus a switch would make oral contraceptives more affordable and accessible to women of all income strata. But more importantly, it would respect women’s autonomy and their right to self‐medicate.