FDA Must Make it Clear Abortion Pills are Dangerous for Women

FDA Commissioner Marty Makary has recently promised to undertake a new review of the “postmarketing safety data on mifepristone for the medical termination of early pregnancy.”

In an open letter to the Commissioner, Elliot Institute director David Reardon, has asked Makary to also direct the FDA to require the abortion pill makers to provide the post-abortion follow-up data necessary to develop evidence-based benefit-risk assessments.

Get the latest pro-life news and information on X (Twitter). Follow @LifeNewsHQ

“Everywhere else in medicine, doctors are expected to make benefit-risk assessments,” writes Reardon, the author of over 50 peer reviewed medical studies examining negative outcomes associated with abortion. “Such assessments are also a core mission for the FDA. It is tasked with approving only those drugs which directly contribute to health benefits that clearly exceed any associated health risks.”

But the “FDA’s regulatory approval of mifepristone in 2000 was driven by political considerations at the expense of women’s health, not by an evidence-based benefits-risks assessment,” says Reardon.

His letter further documents the undisputed fact, reported even by the American Psychological Association, that women who feel pressured into unwanted abortions, attribute more harm to their abortions than good.  In contrast, abortion providers have not yet shown which women, if any, have more measurable benefits than harm.

This has led to indiscriminate prescriptions of mifepristone even to women who are known to be at highest risk of negative outcomes.

Since the FDA is “tasked with approving only those drugs which directly contribute to health benefits that clearly exceed any associated health risks,” Reardon is asking Makary to ensure that any new evaluation of mifepristone must include requirements for “drug trial data that examines both near and long-term psychosocial outcomes associated with mifepristone induced abortions.”

The FDA’s previous evaluations of mifepristone have only examined the drugs efficacy in completing an abortion without serious physical complications. Psychological complications, and longer-term mortality rates, including deaths from suicide, have not yet been considered in FDA reviews.

“In brief, I encourage you to insist that the same standards for benefit-risk assessments that apply to other drugs should also be applied to mifepristone,” Reardon writes to Makary. “Evidence of benefit should not be presumed merely because women consent to an abortion…especially since this consent is often under duress.”

The post FDA Must Make it Clear Abortion Pills are Dangerous for Women appeared first on LifeNews.com.