Family Law Prof Blog

Editor: Margaret Ryznar
Indiana University
Robert H. McKinney School of Law

Monday, January 17, 2022

Agency's Data Under Scrutiny: FDA Data on Chemical Abortions

From Fox News:

Last month, the Food and Drug Administration cited its adverse event (AE) reporting data in justifying its decision to remove the drug's in-person requirement. "FDA determined that the data support modification … to reduce burden on patient access and the health care delivery system and to ensure the benefits of the product outweigh the risks," the agency said.

But a group of anti-abortion physicians is claiming that available data shows a "significant discrepancy" between FDA data and reporting from sources that inform those numbers. Determining the FDA's accuracy is relatively difficult as it requires comparing the agency's own data with those of private entities like Planned Parenthood. The FDA relies on AE reporting from Danco Laboratories, which manufactures the abortion pill and uses AE's reported by Planned Parenthood. Danco did not respond to Fox News Digital's request for comment. 

This isn't the first time the agency's data has come under scrutiny. Critics of chemical or medicinal abortion contend that both U.S. data and the FDA's knowledge of so-called "adverse incidents" is woefully inadequate.

Read more here.

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