New Bill Redefines Pregnancy, Threatens FDA Approval of Abortion Drugs Like Mifepristone

The "Pregnancy Is Not an Illness Act of 2025" aims to fundamentally change how the FDA regulates abortion drugs. The bill prohibits the Department of Health and Human Services (HHS), including the Food and Drug Administration (FDA), from classifying pregnancy as an illness when approving abortion drugs or setting safety protocols (risk evaluation and mitigation strategies) for their use. It gets more drastic: It also nullifies any prior approval of an abortion drug if that approval treated pregnancy as an illness—specifically calling out the approval of mifepristone, effective immediately upon the bill becoming law.

Rewriting the Rules

The core of this bill (SEC. 2) is a direct challenge to the FDA's existing regulatory framework. By stating that pregnancy cannot be considered an illness in the context of abortion drug approval, the bill limits the FDA's ability to assess and mitigate risks associated with these medications. For example, if a woman experiences complications during a medication abortion, the FDA, under this bill, might be restricted in how it can respond, since the underlying condition (pregnancy) can't be classified as an 'illness' in this specific scenario. The bill could also be interpreted to nullify the approval of other abortion drugs in the future if this is part of the FDA's consideration.

Real-World Impact: Access and Safety

This isn't just about semantics. If this bill becomes law, access to mifepristone, a widely used abortion drug, could be immediately jeopardized. Imagine a pharmacy chain that currently stocks mifepristone. If the drug's approval is nullified, they'd likely have to pull it from their shelves, leaving people in many areas with significantly reduced access to medication abortion. This could hit people in rural areas or those with limited transportation options the hardest. Beyond access, there's the safety angle. If the FDA can't consider the risks of abortion drugs in the context of pregnancy, their ability to ensure patient safety is compromised.

The Big Picture: Precedent and Power

This bill raises some serious questions. It sets a precedent for redefining medical conditions through legislation, which could open the door to further political interference in healthcare decisions. The language of the bill is also very broad. The definition of 'illness' could be open to various interpretations, potentially restricting access to a range of reproductive health services. While those who believe pregnancy should not be classified as an illness may view this as a positive, the potential consequences for women's health and the FDA's regulatory authority are significant. The bill also challenges the FDA's power to determine what constitutes a condition requiring medical oversight, a power the agency has historically held.