This piece originally ran on MedCityNews.
If a drug’s FDA approval could be overturned by any judge, anywhere, anytime the pharmaceutical industry would be severely impacted. While mifepristone is no blockbuster, a legal precedent allowing courts to overturn the FDA’s approval could be applied to other drugs like blockbuster drugs like Viagra, Humira, or the new diabetes, weight-loss drugs Ozempic or Wegovy.
Women’s health is once again the center of a political ping-pong match with evidence-based science on one side and anti-choice advocates on the other. The current match involves a Texas lawsuit aimed at overruling the FDA’s 2000 approval of one of the two drugs prescribed for medication abortion, mifepristone. The lawsuit claims, without evidence, that the FDA erred over 20 years ago in approving mifepristone as safe and effective. For the record, mifepristone has been used since by over 5 million women in the US to successfully end early pregnancies. The safety data on the drug is exceptional with far fewer deaths per million users than for penicillin or Viagra. The plaintiffs in the case, The Alliance for Hippocratic Medicine, convinced a Trump-appointed, anti-choice District judge with no medical or scientific training that his assessment of safety and effectiveness was superior to the Federal agency tasked with this responsibility.
Anti-choice advocates are no longer satisfied with the SCOTUS decision in June of 2022 that overturned constitutional protection for abortion and returned the issue to the states to decide. Rather, they want to see abortion banned throughout the United States and have gone after mifepristone to achieve this objective even in states where abortion is legal. Medication abortions now make up over 50% of all abortions in the US and US telehealth providers have increased access to medication abortion in states where abortion is still legal and international organizations allow women to access the drugs to self-manage abortions even in states where abortion is illegal or significantly restricted. This is why mifepristone is at the heart of this current legal and regulatory battle; it is difficult to control access to the drug, not that the drug is unsafe or ineffective.
Banning abortions disproportionately impacts poor women and women of color. Often, these marginalized groups are unable to receive basic health care, including maternity care. In states which have banned abortion, more programs should be developed to ensure that women have healthy pregnancies and births since they are denied the right to avoid pregnancy.
The investment community bears a significant responsibility to address the issue of limited reproductive choices for women. As an investor in the women’s health sector, I have witnessed firsthand the critical role that funding companies working on innovative solutions plays in advancing progress. Supporting these companies is crucial to ensure that women have access to a range of reproductive healthcare options and can make informed decisions about their bodies.
Women’s health has been historically underfunded, and more capital is needed to find investments in solutions to improve maternal health outcomes and to allow people to choose when and if to become parents.
More investment is needed in non-hormonal contraceptive options for both men and women. Most contraceptives on the market today are still hormonal based and many women cannot tolerate or prefer not to take hormones for long periods of time.
Today, current male options are limited to condoms and vasectomies and more innovations are needed to allow men to share the responsibility for managing fertility. With abortion access restricted these contraceptive and maternal health solutions are even more important than ever.
In April the Texas District Judge’s ruling was blocked by the Supreme Court for now and sent back to the appellate court for review by a panel of three judges who heard arguments on May 17. In that hearing, the judges sharply questioned the drugmaker and FDA’s authority. Their ruling could determine whether women have access to a drug that has become the most common method to end a pregnancy in the United States.
The Texas ruling did wake up the sleeping giant pharmaceutical industry who have not traditionally paid attention to women’s health issues particularly one as controversial as abortion. Recognizing the potential damage of allowing judges to overturn FDA regulations on pharmaceutical products, the industry submitted a brief supporting the FDA’s position to the Supreme Court highlighting the damage of this precedent to all regulated FDA products. If a drug’s FDA approval could be overturned by any judge, anywhere, anytime the pharmaceutical industry would be severely impacted. While mifepristone is no blockbuster, a legal precedent allowing courts to overturn the FDA’s approval could be applied to other drugs like blockbuster drugs like Viagra, Humira, or the new diabetes, weight-loss drugs Ozempic or Wegovy. Investors that fund new drug development already underwrite a significant amount of regulatory risk but once the drug is approved by the FDA that risk is eliminated. However, if the judiciary branch is allowed to overrule the FDA as this case requests, this will significantly increase risk to investors.
As the appeal makes its way through the District Appellate Court and, most likely back to the Supreme Court, we will continue to watch this match to see if scientific evidence and regulatory authority will win out over ideology and political views of judges.
