WASHINGTON — An advisory panel of the Food and Drug Administration voted unanimously on May 10 to recommend that a birth control pill be sold in the U.S. without a doctor’s prescription.
The panel’s 17-0 decision is not binding, and the FDA is expected to make a final decision in the upcoming months. But if the recommendation gains final FDA approval, it will be the first time a birth control drug will be sold over the counter in the United States.
The request to sell the contraceptive pill was brought to the FDA by the drug manufacturer Perrigo and would only apply to its product, Opill.
An initial FDA review of Perrigo’s application to sell Opill without a doctor’s prescription raised some concerns over whether those taking the daily pill would be able to follow the labeling directions correctly and if they would realize when they should not take it without consulting a doctor, particularly if they had certain health concerns, such as breast cancer.
Members of the advisory panel said they thought most women would be able to determine if the pill was appropriate for them to use.
Kathryn Curtis, a scientist at the Centers for Disease Control and Prevention who was part of the panel, told reporters that selling Opill over the counter has the “potential to have a huge public health impact,” adding that “the large body of evidence on the safety and effectiveness is very reassuring.”
She said the benefits of making this drug available without a prescription include “reduction in unintended pregnancy and associated risks, and improved reproductive autonomy and improved equitable access to contraception.”
Opill, which is said to be more than 90% effective in preventing pregnancy, was approved by the FDA in 1973.
Although most birth control pills contain a combination of progestin and estrogen hormones, Opill only contains progestin and is said to cause fewer side effects and health risks but can also be less effective if not taken around the same time daily.
The Associated Press reported that several major U.S. medical groups, including the American Medical Association, support making the birth control pill available over the counter. It also said the U.S. Conference of Catholic Bishops opposed this action, saying that women should be evaluated by a doctor before getting the medication.
The U.S. bishops have been vocal against the contraceptive mandate put in place in the Affordable Care Act since this legislation went into effect more than a decade ago. The mandate requires contraceptive and abortion-inducing drugs and devices to be covered by employee health insurance plans with exceptions for religious employers.
Earlier this year, Cardinal Timothy Dolan of New York, chairman of the USCCB’s Committee for Religious Liberty, criticized a proposal by the Biden administration that said employers would no longer be able to refuse contraceptive coverage in their health plans based on moral grounds.
The Catholic Church’s position against artificial birth control is outlined in Pope Paul VI’s 1968 encyclical “Humanae Vitae,” which affirmed church teaching on married love and said the use of artificial contraception was wrong.
The Ethical and Religious Directives for Catholic Health Care Services, developed by the USCCB’s Doctrine Committee, states that “Catholic health institutions may not promote or condone contraceptive practices.”
The National Catholic Bioethics Center in Philadelphia specifically addressed over-the-counter birth control on its website a decade ago when the governor of Louisiana suggested that if birth control was available without prescriptions it would no longer be reimbursable by health insurance and could end some of the political controversy over this issue.
The center, in response, said: “Contraception can never be pro-life. It regularly serves as a gateway to abortion, with abortion functioning as the ‘backup’ to failed contraception for countless women and their partners. Abortion and contraception are two fruits of the same tree, being anti-child and therefore anti-life at the root.”
It also said government leaders “should not be minimizing the medical and moral risks associated with promoting contraceptive use, nor lessening social vigilance by promoting over-the-counter availability.”