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U.S. Food and Drug Administration v. Alliance for Hippocratic Medicine

FDA endangered women's health by removing key safeguards for high-risk abortion drugs

Dr. Donna Harrison, Dr. Shaun Jester, Dr. Tyler Johnson, and Dr. Christina Francis,doctors experienced in caring for pregnant and post-abortive women


Alliance Defending Freedom is representing four national medical associations, their members, and four individual doctors against the FDA for unlawfully removing crucial safety standards for pregnant women who use the abortion drugs mifepristone and misoprostol. Over the past eight years, the agency has removed nearly all of its originally required safety standards that ensured women and girls had ongoing medical care while taking these high-risk drugs. These safeguards included an initial in-person visit to screen for ectopic pregnancies and other serious conditions, and a follow-up visit to check for life-threatening complications like internal bleeding and infection.

The FDA’s job is to keep people safe, but the agency betrayed women and girls by ending these safety standards and encouraging at-home abortions without ongoing care from a doctor. What’s more, the FDA took these reckless actions while acknowledging that roughly one in 25 women who take these drugs will end up in the emergency room.

Women should have the ongoing care of a doctor when taking high-risk drugs, and the U.S. Supreme Court should affirm the 5th Circuit’s decision to hold the FDA accountable for unlawfully failing to protect the health and safety of women and girls.

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Erin Hawley, Senior Counsel, Vice President of Center for Life & Regulatory Practice
Erin Morrow Hawley
Senior Counsel, Vice President of Center for Life & Regulatory Practice
Erin Morrow Hawley serves as senior counsel and vice president of the Center for Life and regulatory practice at Alliance Defending Freedom.
Portrait of Erik Baptist
Erik Baptist
Senior Counsel
Erik Baptist serves as senior counsel at Alliance Defending Freedom, focusing on administrative litigation and regulatory advocacy.