The unprecedented case that could change FDA approval forever
By Planned Parenthood of the St. Louis Region and Southwest Missouri | March 15, 2023, 6 p.m.
Category: Health Services, PP News, Sexual Health
UPDATE from April 13, 2023: Medication abortion is available in Illinois despite an anti-science decision in Texas.
Anti-abortion operatives challenged the FDA’s more than two-decades-old approval of mifepristone, a medication used in combination with misoprostol for medication abortion. On April 7, a federal judge in Texas paused the FDA’s approval of the drug, essentially meaning that the 2000 FDA approval never happened. Minutes later, a federal judge in Washington State ordered the FDA to maintain its approval of mifepristone. Illinois is one of the 17 states (plus DC) covered by the Washington decision that ordered the FDA to not change its approval of mifepristone. Reproductive Health Services of Planned Parenthood of the St. Louis Region will continue to provide medication abortion using mifepristone and misoprostol in Fairview Heights, Illinois. Patients can make an appointment by calling 618-277-6668 or book online.
Overturning Roe v. Wade wasn’t enough for anti-abortion groups. Now — they’re trying to use the court to impede access to sexual and reproductive health care nationwide.
Less than five months after the constitutional right to abortion ended, a group of anti-abortion activists and organizations sued the U.S. Food and Drug Administration (FDA) over its 23 year-old approval of mifepristone, one of two medications most commonly used in medication abortion in the United States. The case, Alliance for Hippocratic Medicine et al v. U.S. Food and Drug Administration et al, was deliberately filed in the Amarillo division of the Northern District of Texas — a division with just one Trump-appointed judge who worked for anti-abortion organization. The Alliance for Hippocratic Medicine is one of many sham organizations that have actively worked to undermine sexual and reproductive health care including involvement in Dobbs v. Jackson Women’s Health Organization,the case that overturned Roe v. Wade.
This case has national implications that impact all people seeking abortion care. Any additional restrictions or judicial overreach related to abortion access will worsen the public health crisis in a post-Roe reality..
Medication abortion allows people to manage their abortions on their own terms, expands access to abortion care, and reduces abortion stigma. As more states ban or severely restrict abortion, it’s more important than ever for people to have more options to access care in critical access states.
Mifepristone is a proven safe and effective method of abortion. According to Advancing New Standards in Reproductive Health, medication abortion has a safety record of 99 percent. In addition to being used for terminating a pregnancy, mifepristone is used for miscarriage management and diabetes treatments.
Public support for medication abortion is clear. A February 2023 Ipsos poll shows the overwhelming majority of people believe medication abortion should remain legal.
Ideological operatives should have no place in the FDA’s thorough and stringent approval process. The devastating implications of this case go beyond abortion access. This case threatens the FDA’s authority over medication approval and could have far-reaching consequences for patients’ access to other FDA-approved medications.
To understand the baseless claims and truly unprecedented nature of the case, the Washington Post breaks it down.
- “Legal experts said that such a ruling, if upheld, could lead to a highly politicized regulatory environment, with approvals for controversial treatments facing court challenges and being thrust into the middle of culture wars. Coronavirus vaccines or hormone treatments for transgender people, they said, could be endangered by judges with no scientific background.”
- “Critics say the legal theories in the lawsuit are specious, but they acknowledge that Kacsmaryk’s ruling could sow confusion over FDA regulations, weakening an agency at a time when scientific and medical expertise are under attack, possibly inviting lawsuits over any number of previously approved medications.”
- “The FDA is virtually never reversed by a court on scientific decisions because courts invariably recognize that they don’t have the expertise to make scientific decisions,” said Scott Lassman, a D.C. attorney who specializes in FDA regulatory issues. “And it is even more rare — I’d say unheard of — for this type of scientific challenge to be made in court 20 years after FDA’s decision.”
According to policy experts, possible outcomes for the case include:
- “Kacsmaryk could determine that the agency did not apply a lawful review process for its initial approval of mifepristone, which “would be unprecedented for a Court to rule that the FDA did not properly approve a drug,” Kaiser Family Foundation researchers wrote.”
- “Another option: a more limited ruling that would get rid of prior rules that eliminated the in-person dispensing requirement and allowed for telehealth abortions.”
- “He could toss the lawsuit, embracing the Justice Department argument that the groups don’t have standing to sue.”
Planned Parenthood of the St. Louis Region and Southwest Missouri will always be here for patients. Learn more about abortion options at our health center in Fairview Heights, Illinois.
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What’s MO got to do with the FDA Mifepristone case?
Tags: Abortion, Roe v. Wade, reproductive health, AbortionProviders, mifepristone, MIFE
