Misinformation Obscures America’s Most Popular Emergency Contraception

A brand of specialty mozzarella cheeses. A set of natural gas storage terminals. And the best-selling emergency contraception in the United States.

At a time when half of America’s states are on the verge of banning or drastically reducing abortion services, the latest pill for women to avoid an unwanted pregnancy hinges on the unlikely management of two private equity firms. investment whose investment portfolios range from vineyard-managed Italian foods 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 Israel-based pharmaceutical giant sold its global women’s health business. In the years that followed, the drug became the most widely used over-the-counter emergency contraception in the United States and, at an average cost of $45 per dose, one of the most expensive over-the-counter drugs. sold in the United States.

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

But the running of the business 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 womb becomes a legitimate legal standard among Republican lawmakers in state capitols and in Congress. If the Supreme Court cements a leaked draft decision to overturn Roe vs. Wade without explicitly deferring to the medical standard of the onset of a pregnancy—that is, after implantation—Republican-controlled legislatures could declare that Plan B and intrauterine devices, or IUDs , are abortive.

States that enact legislation granting “human rights” to fertilized eggs, embryos and fetuses would open a new frontier in laws that dictate the options available to pregnant women and those trying not to become pregnant. States considering such a move include Alabama, Missouri and Kansas.

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political battle, women’s health advocates say the Consumer Healthcare Foundation and the FDA have failed to correct outdated wording on the product’s label, leading to widespread misinformation about how it works.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

The language in question, set out as part of Plan B’s “drug facts”, warns that the pill could prevent “a fertilized egg from attaching to the uterus”. But 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 does not harm an existing pregnancy, according to the American College of Obstetricians and Gynecologists.

This packaging language has nevertheless been cited to justify regulations in at least nine states that exclude Plan B from government family planning programs and birth control coverage mandates or allow pharmacists to refuse to sell Plan B. for moral reasons.

The 2014 U.S. Supreme Court decision in Burwell v. Hobby Lobby Stores cited the FDA’s Plan B webpage in a ruling that requiring family businesses with religious beliefs 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.” plan B pill kills a baby in the womb once a woman is already pregnant,” U.S. Rep. Marjorie Taylor Greene (R-Ga.) erroneously said during a floor debate. “The VA shouldn’t pay for abortion.”

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

Making a similar label change in the United States 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 up with the data and ask for a label change,” said Susan Wood, a professor of health policy at George Washington University and former director of patient health. women at the FDA. A label update would be “simple because there is human data that shows it works before ovulation.”

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

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

“FCH’s mission is and always has been to increase education 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 make sure everyone understands how the product works and when it should be taken, and with retailers to make sure the product is available in all major retail stores.”

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

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

Plan B’s labeling problem dates back to its creation as an over-the-counter pill in 2006. When the pharmaceutical company that owned Plan B at the time, Barr Pharmaceuticals, applied to the FDA for permission to sell it in over-the-counter, the effort was met with opposition. anti-abortion forces, according to historical accounts, as well as interviews with those involved. These forces included a member of the scientific advisory committee responsible for reviewing the application. Dr. Joseph Stanford, a Mormon physician who believed that life begins at fertilization, argued that there was a remote possibility that Plan B could prevent the implantation of a fertilized egg.

Despite the lack of scientific evidence to support this claim, the company agreed to list the post-fertilization mechanism on the packaging as a means of gaining approval for the claim.

This seemingly innocuous capitulation paid off 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 assistant professor Christopher ChoGlueck. 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 only required to disclose limited information, which obscures their operations and holdings.

But pharmaceutical industry analysts say the company 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 largely 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 aged 15-44 who had ever had sex said they had used emergency contraceptive pills at least once, up from 4% in 2002, analysis shows KFF from Centers for Disease Control and Prevention survey data. .

Private equity firms typically raise funds from institutional investors, often with an emphasis on generating short-term income. When Kelso and Juggernaut Capital acquired Plan B in 2017, the campaign to end federal abortion rights, after decades of legal challenges, reportedly made buying the nation’s most popular emergency contraceptive a tempting option. “Private equity feels a possibility wherever vulnerable people are involved,” said Eileen Appelbaum, co-director of the Center for Economics and Policy Research.

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

Other anti-abortion state investors include the University of Houston System Endowment and the Houston Police Officer Retirement System.

“With clients buying Plan B, it could be very good for their investors, regardless of their comfort level with taking advantage of Plan B,” said Eileen O’Grady of the Private Equity Stakeholder Project, which studies holdings. tangles of private equity. businesses.

Miller and other industry experts say Foundation can maintain its $45 average price for Plan B because of its market dominance. Low-cost generic emergency contraception is available, largely online, said Dima Qato, 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 shut out competitors.

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

Still, if a Supreme Court ruling allows states to criminalize abortion and certain contraceptives, Kelso and Juggernaut’s investment would certainly be in jeopardy. States oversee pharmacy laws, giving legislatures wide leeway to allow pharmacies to refuse to dispense emergency contraception.

“Texas and other states will claim it looks like an abortion pill,” Qato said, “and they’ll say you can’t sell it.”

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