Misinformation tarnishes America’s favorite emergency contraception

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

At a moment when half of US states are poised to ban or severely restrict abortion services, the last pill for women trying to prevent unwanted pregnancy lies in the unlikely leadership of two private equity firms whose investment portfolios ranging from Italian food to vineyard management to cough medicine for children.

Kelso & Co. and Juggernaut Capital Partners bought Plan B One-Step from Teva for $675 million in 2017 when the Israel-based pharmaceutical giant sold its global women’s health business. In the years since, the drug has become America’s most widely used over-the-counter emergency contraceptive and — averaging $45 per dose — is one of the most expensive over-the-counter drugs sold in the United States

Foundation Consumer Healthcare, Kelso and Juggernaut’s company that sells Plan B, has managed to aggressively market the product while staying under the radar of abortion advocates and Republican lawmakers who denigrate it as another form of abortion.

But the company’s leadership and women’s continued access to Plan B have become pressing concerns as the religious belief that life begins before a fertilized egg implants in the uterus has increased among Republican lawmakers in state capitals and the United States Congress gains importance as a legitimate legal standard. If the Supreme Court issues a leaked draft decision overturning Roe v. Wade cements, without specifically citing the medical standard of beginning a pregnancy — that is, after implantation — that Republican-controlled lawmakers could declare Plan B and intrauterine devices, or IUDs, as abortifacients.

States that legislate to confer “personal rights” on fertilized eggs, embryos, and fetuses would create a new legal boundary that dictates the options available to women who are pregnant and those who are not. States considering such a move include Alabama, Missouri and Kansas.

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battle, women’s health advocates say, is that the Consumer Healthcare Foundation and the FDA have failed to correct outdated product label wording, leading to widespread misinformation about how Plan B works.

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

However, this packaging language has been used to justify regulations in at least nine states that exclude Plan B from state family planning programs and birth control requirements, or that allow pharmacists to refuse to sell Plan B on moral grounds.

The US Supreme Court’s 2014 decision in Burwell v. Hobby Lobby Stores cited the FDA’s Plan B website, which ruled that the obligation of family businesses with religious beliefs to pay for birth control health insurance coverage , violates a federal law protecting freedom of religion.

Similarly, a bill before Congress that would require Department of Veterans Affairs agencies to fund the cost of all forms of contraception for female veterans was blocked by opposition to Plan B’s inclusion. “The Plan B pill kills a baby in the womb once a woman is already pregnant,” US Rep. Marjorie Taylor Greene, R-Ga., erroneously declared during a debate. “The VA should not pay for abortions.”

European authorities demanded that the language be removed from Plan B packaging sold in those countries in 2015, and it was opposed by the International Federation of Gynecology and Obstetrics and American medical associations.

A similar label change in the US would require the Consumer Healthcare Foundation to file an application with 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 up with the data and request a label change,” said Susan Wood, professor of public health policy at George Washington University and former director of women’s health at the FDA. Updating the label would be “easy because there is human data showing it works before ovulation.”

“It’s the company’s responsibility,” she added.

Foundation Consumer Healthcare, in an email response to a list of questions from KHN, declined to be interviewed and said it would not comment on sales figures, discussions with the FDA, or investment plans.

“FCH’s mission is and always has been to increase the awareness and availability of Plan B One-Step® emergency contraception for women across the country,” the company wrote. “We are working with a variety of partners to ensure everyone understands how the product works and when it should be taken, and with retailers to ensure the product is available in all major retail locations.”

The FDA also declined to comment, citing regulations that protect “the confidentiality of commercial information.”

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

Plan B’s labeling problem dates back to its introduction as an over-the-counter pill in 2006. When the drug company that owned Plan B at the time, Barr Pharmaceuticals, applied for FDA over-the-counter sales permission, the effort met opposition from anti-abortion forces, according to historical accounts, as well as interviews with people involved. These forces included a member of the Scientific Advisory Board that reviewed the application. dr Joseph Stanford, a Mormon doctor who believed that life begins at fertilization, argued that there was a remote possibility that Plan B could prevent implantation of a fertilized egg.

Although there was no scientific evidence to support this claim, the company agreed to list the post-fertilization mechanism on the packaging in order to gain approval for use.

This seemingly harmless capitulation has paid off for anti-abortion advocates, 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, who documented the history of emergency contraception.

Foundation Consumer Healthcare’s investment in Plan B is difficult to assess: private equity firms are required to disclose limited information and to conceal their businesses and interests.

However, pharmaceutical industry analysts say the business is clearly profitable. Emergency contraception is relatively inexpensive to manufacture, said Samantha Miller, co-CEO of Cadence Health, a biopharmaceutical company developing over-the-counter birth control pills. And the customers are predominantly young women who buy the pill without a prescription, even if they – or their parents – have health insurance.

Between 2013 and 2015, 22% of women ages 15 to 44 who had ever had sex said they had used the emergency contraceptive pill at least once, up from 4% in 2002, according to a KFF analysis of the center’s survey data for Disease Control and Prevention.

Private equity firms typically raise funds from institutional investors, often with a focus on generating short-term revenue. When Kelso and Juggernaut Capital acquired Plan B in 2017, the campaign to end federal abortion laws, culminating after decades of legal challenges, would have made buying the nation’s most popular emergency contraception a tempting option. “Private equity sees an opportunity wherever vulnerable people are involved,” said Eileen Appelbaum, co-director of the Center for Economic and Policy Research.

Interestingly, one of the largest investors in two Kelso funds that have invested in Foundation Consumer products is the Teachers’ Retirement System of Louisiana, one of at least 13 states with trigger laws that would ban abortions if Roe falls.

Other investors from anti-abortion states include the University of Houston System Foundation and the Houston Police Officers’ Pension System.

“If clients buy Plan B, it could be very good for their investors, regardless of how comfortable they are with Plan B,” said Eileen O’Grady of the Private Equity Stakeholder Project, which studies the convoluted holdings of private equity firms.

Miller and other industry experts say Foundation is able to maintain its $45 median price for Plan B because of its market dominance. Cheaper generic emergency contraceptives are mostly available online, said Dima Qato, an associate professor of clinical pharmacy at the University of Southern California. But Plan B’s distribution deals with national pharmacies, Walmart, and Target have largely locked out competitors.

“People don’t use the generics, and not many places carry them,” Qato said. “They want to make sure it’s effective. There is a preference for the brand.”

However, should a Supreme Court decision allow states to criminalize abortion and certain contraceptives, Kelso and Juggernaut’s investment would certainly be at risk. States monitor pharmacy laws, leaving lawmakers plenty of leeway to allow pharmacies to refuse to dispense emergency contraceptives.

“Texas and other states will claim that this resembles an abortion pill,” Qato said, “and they will say you can’t sell it.”

Sarah Varney, Kaiser Health News. (KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism on health issues. Along with Policy Analysis and Polling, KHN is one of the three main operating programs at KFF (Kaiser Family Foundation). KFF is a non-profit foundation organization dedicated to the nation provides information on health issues.)

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