Future of America's most popular emergency contraception is complicated by misinformation

(KHN)特製モッツァレラチーズのブラン​​ド. 天然ガス貯蔵ターミナルのコレクション. And America’s top-selling emergency contraception.

At a moment when half of US 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 varied investment portfolios include Italian foods, vineyard management and children’s cough medicine.
Kelso & Co. そして Juggernaut Capital Partners bought Plan B One-Step from Teva Pharmaceutical Industries Ltd. にとって $ 675 百万 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 US.
    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 anti-abortion 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 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.
          States that enact legislation to conferpersonhood rightsto 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battle, women’s health advocates say, is that Foundation Consumer Healthcare and the FDA have failed to correct outdated wording on the product’s label that has led to rampant misinformation about how Plan B works.
          The language in question, stated as part of Plan B’sdrug facts,” warns that the pill could preventattachment 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 US Supreme Court’s 2014 decision in Burwell v. Hobby Lobby Stores cited the FDA’s web page 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.
          同様に, 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,” 米国の担当者. マージョリーテイラーグリーン (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, and it has been rejected by the International Federation of Gynecology and Obstetrics and American medical associations.
          Making a similar label change in the US 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 professor of health policy at George Washington University and former director of women’s health at the FDA. A label update would bestraightforward because there is human data that shows that it works prior to ovulation.
          It’s the company’s responsibility,” 彼女は付け加えた.
          Foundation Consumer Healthcare, in an emailed response to a list of questions from KHN, declined an interview and said it would not comment on sales figures, discussions with the FDA or investment plans.
          The mission of FCH is and always has been increasing the education and availability of Plan B One-Step® emergency contraception for women across the country,” the company wrote. “We work with a variety of partners to ensure 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 protectthe confidentiality of commercial information.
          Emboldened by the Supreme Court’s leaked draft decision on Roe and its earlier decision to allow Texassix-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 anti-abortion forces, による historical accounts, as well as interviews with people involved. Those forces included a member of the scientific advisory panel reviewing the application. 博士. 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 post-fertilization 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, 前記 Christopher ChoGlueck, an assistant professor of ethics at New Mexico Tech who has 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 only limited information, obscuring their operations and holdings.
          But drug industry analysts say the business is clearly profitable. Emergency contraception is relatively inexpensive to make, 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 over the counter even if they — or their parents — have health insurance.
          の間に 2013 そして 2015, 22% of women ages 15 に 44 who had ever had sex reported having used emergency contraception pills at least once, an increase from 4% に 2002, によると KFF analysis of US Centers for Disease Control and Prevention survey data.
          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 rights, cresting after decades of legal challenges, would have made the purchase of the nation’s most popular emergency contraception a tantalizing option. “Private equity senses a possibility wherever vulnerable people are involved,” said Eileen Appelbaum, co-director of the Center for Economic and Policy Research.
          興味深いことに, one of the biggest investors in two Kelso funds invested in Foundation Consumer products is the 教師’ Retirement System of Louisiana, の一つ 14 states with trigger laws that would ban abortion if Roe falls.
          Other investors from anti-abortion states include the University of Houston System endowment and the Houston Police OfficersPension System.
          With customers buying up Plan B, this could be very good for their investors regardless of their level of comfort profiting off of Plan B,” said Eileen O’Grady, of the Private Equity Stakeholder Project, who researches the tangled holdings of private equity firms.
          Miller and other industry experts say Foundation can maintain its $ 45 average price tag for Plan B because of its market dominance. Lower-priced 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 arrangements with national pharmacies, ウォルマート, and Target have largely locked out competitors.
          People don’t use the generics, and not many places carry them,” Qato said. “You want to make sure it’s effective. There is a preference for the brand.
          CNNHealthの週刊ニュースレターを入手する

          こちらからサインアップして入手してください 結果は博士と一緒にあります. サンジェイグプタ CNNヘルスチームから毎週火曜日.

            それでも, if a Supreme Court decision permits states to criminalize abortion and certain contraceptives, Kelso and Juggernaut’s investment would certainly be imperiled. States oversee pharmacy laws, leaving ample room for legislatures to allow pharmacies to refuse to dispense emergency contraception.
            Texas and other states will claim this is similar to an abortion pill,” Qato said, “and they will say you can’t sell it.

            コメントは締め切りました.