How Contraception is Regulated and Obtained in the United States
Birth Control Access and Regulation in the United States
The R Street Institute has worked for years on reducing barriers for consumers to obtain hormonal contraception across the United States. However, the federal government and state governments both regulate access to birth control and it is critical policymakers and consumers understand how this system of regulations is designed. This is a brief overview of how hormonal contraception is regulated to provide a better understanding of how and if contraceptive access in the United States could change. Please contact the author for additional information on any of these access questions.
What is the purpose of hormonal birth control?
Hormonal birth control is used to prevent or to time pregnancy, as well as to treat a number of other health conditions like dysmenorrhea, menorrhagia, acne prevention, endometriosis and more. These methods include birth control pills, patches, injections and vaginal rings, as well as long-acting reversible contraception like intrauterine devices and implants. The widespread use of hormonal contraception is vast, with 82 percent of sexually active women in the United States having used the pill at some point in their reproductive years.
Is birth control regulated by the federal government or state governments?
Both. Hormonal birth control is regulated in a number of ways at both the federal and state levels.
How is birth control regulated by the federal government?
The federal government is primarily responsible for determining which birth control products can enter the market, whether they require a prescription or can be available over the counter, and various aspects around access as they relate to health insurance coverage.
When birth control products are entering the market, the Food and Drug Administration (FDA) is tasked with ensuring their safety and efficacy before they are available to consumers. Approval for drugs goes through the FDA, not through the legislative or judicial branches of government. Drug manufacturers are responsible for producing all required clinical trial data and other medical evidence to the FDA, and must apply for each drug they intend to offer, whether it’s by prescription or over the counter. The only exception to this is if a manufacturer is bringing a drug to market that includes ingredients already established as safe for over-the-counter use in an FDA Over-the-Counter (OTC) Monograph.
The FDA also determines prescription status. Based on the process of approval, the FDA determines whether a drug is safe for OTC status or requires a prescription. This decision is based on general guidelines established by the FDA.
Additionally, federal law mandates that health insurance plans—with a few exceptions—cover the full range of available contraceptives without cost-sharing. These exceptions include religious institutions and organizations (both for-profit and non-profit organizations) with moral exceptions.
If the FDA determines prescription status, have they allowed any hormonal birth control to be available completely over the counter?
Yes. Emergency hormonal contraception, most commonly known as Plan B, is available over the counter, regardless of patient age. This decision to make emergency contraception available over the counter, even as a hormonal method, was based on FDA review of the medical evidence available on emergency contraception’s use, risks and mechanism of preventing pregnancy. This method is not intended as a routine contraceptive, so all regular methods of hormonal contraception are still behind a prescription barrier.
It is important to note that, while the FDA approved emergency contraception for OTC status, states still determine some aspects of insurance coverage for emergency contraception and pharmacists’ right of refusal to provide it. However, overall, emergency hormonal contraception is available without a prescription and without proof of age in every state.
How is birth control access regulated by the states?
State laws and regulations determine who can prescribe regular methods of hormonal contraception within state borders, which is known as the scope of practice for healthcare professionals.
Who can prescribe regular methods of hormonal contraception?
Physicians are permitted to prescribe hormonal contraception in every state. But in many cases, so are advanced practice nurses—such as nurse practitioners, and other nurses with advanced degrees beyond Registered Nurse (RN) requirements. In a few cases, like in some state clinics, RNs can dispense contraception directly to patients.
Outside of medical offices, in roughly half of all states, pharmacists are also able to prescribe or directly furnish hormonal contraception to qualified patients.
The ability of non-physicians to prescribe hormonal contraceptives is achieved in one of three main ways. First, state legislatures can pass laws that give pharmacists the ability to prescribe contraceptives. Second, state agencies, such as a state board of medicine or state board of pharmacy, can make changes to regulations that may expand the scope of practice for pharmacists to include some prescribing abilities without the legislature’s approval. Third, some states employ existing collaborative practice agreements (CPAs) that allow pharmacies and physicians to determine prescription abilities. Under existing state laws, CPAs create a supervisory relationship between a physician and pharmacist. In establishing this formal relationship, some duties can be delegated to pharmacists, including the prescription of birth control.
For more on where pharmacists can prescribe birth control, see Birth Control Pharmacies.
What are the implications of the Supreme Court’s decision to overturn Roe v. Wade on contraception?
In the longer term, it is unclear whether the overturning of Roe v. Wade will lead directly to a similar legal challenge for contraception that rises to the Supreme Court.
However, on page 119 of the opinion in Dobbs v. Jackson Women’s Health Organization, Justice Clarence Thomas wrote in his concurrence,
. . . in future cases, we should reconsider all of this Court’s substantive due process precedents, including Griswold, Lawrence, and Obergefell. Because any substantive due process decision is “demonstrably erroneous” . . .
Griswold v. Connecticut was the decision in 1965 that established the right to privacy for married couples to use contraception should they so choose without state restrictions. Given Justice Thomas’s reference to Griswold, the Roe decision could have downstream effects for a potential challenge to the Griswold decision. However, the overturning of Roe does not automatically mean that contraception is also banned in some states.
Additionally, the political reality is that the overwhelming majority of Americans support using birth control. This is true of Americans regardless of religious beliefs, political affiliation, marital status and age. In the 2022 Gallup Values and Beliefs poll, which takes an annual measure of Americans’ attitudes toward a list of issues, birth control continued to be the most morally acceptable.
What can Congress do to change the landscape of contraceptive prescribing?
Congress oversees the FDA, and while Congress cannot make medical decisions for them, they can require the FDA to prioritize certain cases. In the last few congressional sessions, Sen. Joni Ernst (R-Iowa) has introduced a bill that urges the FDA to fast track applications from existing birth control manufacturers to issue a birth control pill with OTC status. It also would require the FDA to waive the application fees, making the process less burdensome to manufacturers. This bill has not passed the Senate since its first introduction, largely due to concerns over a lack of insurance coverage if birth control were to become over the counter.
