Misinformation clouds America’s most popular emergency contraception

A brand of specialty mozzarella cheeses. A collection of natural-gas storage terminals. And America’s top-selling emergency contraception.

At a moment when half of U.S. states stand poised to outlaw or sharply curtail abortion services, the last-ditch pill for women aiming to stave off an unwanted pregnancy rests in the unlikely stewardship of two private equity firms whose investment portfolios range from Italian foods to vineyard management to children’s cough medicine.

Kelso & Co. and Juggernaut Capital Partners bought Plan B One-Step from Teva for $675 million in 2017 as the Israeli-based pharmaceutical giant was selling off its global women’s health business. In the years since, the drug has become America’s most widely used over-the-counter emergency contraception and — at an average cost of $45 per dose — one of the highest-priced over-the-counter medications sold in the U.S.

Foundation Consumer Healthcare, the company owned by Kelso and Juggernaut that sells Plan B, has managed to aggressively market the product while staying under the radar of antiabortion activists and Republican lawmakers who vilify it as another form of abortion.

But the company’s stewardship and women’s continued access to Plan B have become matters of urgent concern as the religious belief that life begins before a fertilized egg implants in the uterus gains currency as a legitimate legal standard among Republican lawmakers in state capitals and in Congress. If the U.S. Supreme Court cements a leaked draft decision to overturn Roe v. Wade without explicitly deferring to the medical standard of when a pregnancy begins — which is after implantation — Republican-controlled legislatures could declare Plan B and intrauterine devices, or IUDs, to be abortifacients, or agents that induce abortions.

States that enact legislation to confer “personhood rights” to fertilized eggs, embryos, and fetuses would open a new frontier in laws that dictate the options available for women who are pregnant and those who seek not to become pregnant. The states considering such a move include Alabama, Missouri, and Kansas.

Complicating that political battle, women’s health advocates say, is that Foundation Consumer Healthcare and the FDA have failed to correct outdated wording on the product’s label, which has led to rampant misinformation about how Plan B works.

The language in question, stated as part of Plan B’s “drug facts,” warns that the pill could prevent “attachment of a fertilized egg to the uterus.” But numerous studies have shown that is not the mechanism of action for Plan B, a hormonal medication that delays ovulation and can prevent sperm from fertilizing an egg. Research also shows Plan B does not harm an existing pregnancy, according to the American College of Obstetricians and Gynecologists.

That packaging language has been cited, nonetheless, to justify regulations in at least nine states that exclude Plan B from government family planning programs and contraception coverage mandates or that allow pharmacists to refuse to sell Plan B on moral grounds.

The Supreme Court’s 2014 decision in Burwell v. Hobby Lobby Stores cited the FDA’s webpage about Plan B in ruling that requiring family-owned corporations with religious convictions to pay for health insurance coverage for contraception violated a federal law protecting religious freedom.

Similarly, a bill before Congress that would require Department of Veterans Affairs facilities to cover the cost of all forms of contraception for female veterans has been stalled by opposition to the inclusion of Plan B. “The Plan B pill kills a baby in the womb once a woman is already pregnant,” U.S. Rep. Marjorie Taylor Greene (R., Ga.) erroneously stated during a floor debate. “The VA should not be paying for abortion.”

European authorities required the language be dropped from Plan B packaging sold in those countries in 2015.

Making a similar label change in the U.S. would require Foundation Consumer Healthcare to petition the FDA — an action that women’s health advocates say is long overdue.

“The FDA isn’t going to change it unless the companies come in with the data and ask for a label change,” said Susan Wood, a health policy professor at George Washington University and former director of women’s health at the FDA. A label update would be “straightforward because there is human data that shows that it works prior to ovulation.”

Foundation Consumer Healthcare, in an emailed response to a list of questions from Kaiser Health News (KHN), declined an interview and said it would not comment on sales figures, discussions with the FDA, or investment plans.

Emboldened by the Supreme Court’s leaked draft decision on Roe and its earlier decision to allow Texas’ six-week abortion ban to take effect, lawmakers in multiple Republican-led states already are openly considering bans on emergency contraception and IUDs.

Plan B’s labeling issue dates to its inception as an over-the-counter pill in 2006. When the drug company that owned Plan B at the time, Barr Pharmaceuticals, sought FDA permission to sell it over the counter, the effort faced opposition from antiabortion forces, according to historical accounts, as well as interviews with people involved. Those forces included a member of the scientific advisory panel reviewing the application. Joseph Stanford, a Mormon physician who believed life begins at fertilization, argued that a remote possibility existed that Plan B could prevent implantation of a fertilized egg.

Despite having no scientific evidence to support that claim, the company agreed to list the postfertilization mechanism on the packaging as a way of getting the application approved.

That seemingly innocuous capitulation has paid dividends for abortion opponents, codifying in official government documents a mechanism of action that would be used to blur the line between contraception and abortion, said Christopher ChoGlueck, an assistant professor of ethics at New Mexico Tech.

Kaiser Health News (KHN) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at Kaiser Family Foundation (KFF). KFF is an endowed nonprofit organization providing information on health issues to the nation.