Access to reproductive healthcare is about to get harder for millions of Americans in the wake of the Supreme Court's decision to overturn Roe v. Wade, and women's healthcare companies in the Bay Area are bracing for whatever comes next.
The Supreme Court's 6-3 ruling effectively sends the issue of abortion back to the states, and will likely lead to a patchwork of inconsistent laws about whether people who can get pregnant have access to safe and affordable abortions where they live or have to travel long distances.
The ruling also raises questions about the future of birth control and emergency contraception, which many telehealth companies currently provide to patients nationwide. Fears were heightened by written comments by Justice Clarence Thomas that the court should seek opportunities to reconsider rights beyond abortion that were established by previous rulings rather than explicitly by the U.S. Constitution.
In the Bay Area, these companies include Nurx (recently acquired by Thirty Madison), Favor (formerly known as The Pill Club) and Pandia Health. In addition to birth control, Choix also offers patients access to abortion pills. And another startup called Cadence is trying to bring birth control pills to the market as an over-the-counter, non-prescription option.
"In light of today’s news, Cadence is more determined than ever to cross any hurdles necessary to bring the birth control pill over-the-counter — this is a potential avenue to make oral contraceptives more accessible and affordable throughout every state in the US,” Cadence co-founder and co-CEO Samantha Miller told the Business Times in an emailed statement.
Cadence is based in Oakland and was founded in 2014 by Miller and co-CEO Nap Hosang. It's one of at least two companies pushing to make hormonal birth control available without a prescription. The other is Paris-based HRA Pharma. Both companies have been in discussions with the U.S. F.D.A. since 2016, as previously reported by the NYT. It's unclear how long it might take to clear regulatory hurdles.
Birth control
Birth control pills have been on the market in the U.S. since 1960 when the pharmaceutical company G.D. Searle won FDA approval for its oral contraceptive, Enovid. Other non-permanent contraceptives include cervical rings and dermal patches.
Nurx, Favor and Pandia Health provide their patients with hormonal birth control options and emergency contraception.
Since Politico published a leaked draft of the Supreme Court's decision in early May, Nurx says it has seen a 300% increase in requests for emergency contraception. The San Francisco company was acquired by Thirty Madison in February.
And Favor is already fielding questions from its members about the ruling. The San Mateo company sent patients an email this morning reassuring them that their products are still legal in all 50 states and D.C., and that emergency contraception is not abortion.
“Today’s Supreme Court ruling on abortion access poses an immediate threat to public health and personal freedom. As a reproductive care provider, we know firsthand how many hoops women and people who menstruate have to jump through to get basic care. We stand with our patients in the face of this outrageous decision and remain as committed as ever to expanding their access to health care — particularly in contraceptive deserts, where many of our patients live,” Favor's CEO Liz Meyerdirk said in a statement via email.
Favor has also compiled a list of resources for people seeking abortion services and information and launched an online campaign calling on people to send their legislators messages asking them to enact mandatory vasectomies.
Intrauterine devices were developed as far back as the early 1900s and are available in hormonal and non-hormonal options today. Medicines360, which has partnered with AbbVie Inc.-owned by Allergan since 2013, won Food and Drug Administration for its affordable hormonal IUD that can be used for up to six years.
On Friday, the San Francisco nonprofit said it was making its hormonal IUD available free of charge to patients in the U.S. via clinics that work with Santa Barbara-based charity Direct Relief.
Medicines360's leadership warned of barriers to contraception when the Trump Administration proposed rule changes to a federal program called Title X to limit the availability of and access to IUDs.
Title X, administered by the Department of Health and Human Services, provides grants for family planning, counseling and services. It focuses on low-income people at more than 3,500 sites, such as public health departments and nonprofit community health centers.
The Trump Administration's rule change eliminated a requirement that grant awardees offer all 18 FDA-approved contraceptive methods for women, which would allow organizations to offer family-planning products that hadn't gone through the FDA's rigorous, evidence-based testing.
The Biden Administration has proposed overruling the changes.
"In 1965, the Supreme Court majority based their decision in Griswold v. Connecticut around the right to privacy — a landmark decision that provided the first constitutional protection for birth control," Medicines360 CEO Dr. Tina Raine-Bennett said in a statement. "In the wake of today's decision, further rights are at risk, including the right to contraception."
Medication abortions
Abortion pills may be the most controversial, and legally tricky, of all women's telehealth services.
Choix currently provides abortion pills to eligible patients who are within 10 weeks of pregnancy in California, Colorado and Illinois — three of the nearly dozen states that the Guttmacher Institute has identified as safe havens for abortion access in the U.S. — and the San Rafael company wants to expand to every state where it's legal by 2023.
"The decision to reverse a hard-fought constitutional right to abortion care is devastating and today, we are grieving," Choix co-founder and CEO Cindy Adam told me via email. "Abortion rights is an economic, health and human rights issue. The chilling effects of today’s ruling disproportionately impact people of color and underserved communities – heightening broader healthcare inequities."
The company says that although they can only prescribe abortion pills to people in these three states at the moment, patients don't have to legally reside in those states to receive care.
Which raises the reality that patients could cross state lines to receive abortion care of all sorts, including through telemedicine.
Sunnyvale-based Pandia Health currently offers services in 14 states: California, Colorado, Arizona, Florida, Texas, Arizona, Georgia, Illinois, Michigan, Nevada, New York, Tennessee, Washington and Wyoming.
CEO and founder Sophia Yen wants to expand to more states but "we also encourage birth control tourism," she told me. In other words, if a telehealth service isn't available in your state, it may be accessible simply by crossing state borders.
Pandia Health doesn't offer abortion pills, though, and doesn't plan on adding it as a service for the time being due to legal concerns.
"We are not doing medication abortion because if I lose my (medical) license, then we lose all 14 states," Yen, who's a doctor, told me.
Biosciences R&D
The ruling has little to no impact on the California Institute for Regenerative Medicine, the state taxpayer-backed agency that funds research and development of stem cell therapies. CIRM, initially approved by voters who passed a $3 billion bond measure in 2004, was a reaction to President George W. Bush's limitation on federal funding of research using embryonic cell lines for basic research and, eventually, therapies for a broad range of diseases.
Cell lines are cell cultures derived from a single cell from aborted fetuses.
CIRM's funding, renewed by voters in a $5.5 billion bond measure in 2020, is separate from federal funding.
Embryonic cells are golden for researchers because they are pluripotent, meaning they can be prodded to develop into heart cells, liver cells or the cells of any other organ. But the research of Nobel Prize winner Dr. Shinya Yamanaka, now a senior investigator at the Gladstone Institutes in San Francisco, and others showed that mature stem cells also could be engineered to a pluripotent state.
"Most of the places seem to have enough cell lines already," CIRM spokesman Kevin McCormack said, noting that the mRNA vaccines for Covid-19 were developed in part from fetal tissue from the 1970s. "People have this supply already. There's no real need for more."
South San Francisco-based cell therapy developer Nkarta Inc. CEO Paul Hastings, who in May called on biotech companies to pay the travel expenses of employees in states blocking access to reproductive care, called the Supreme Court decision "pathetic and incompetent."
"I am embarrassed to live in a country whose Supreme Court conservative judges consider women as second-class citizens," Hastings texted.
Hastings said he was speaking as the CEO of Nkarta and not as the board chair of the Biotechnology Innovation Organization, the biotech industry trade group that interacts with legislators in lobbying on various measures.
