NWHN Statement on FDA’s Decision on Generic Drug Labels

The following statement can be attributed to Cynthia A. Pearson, Executive Director of the National Women’s Health Network.

Washington, D.C. — Today the U.S. Food and Drug Administration (FDA) announced their decision to withdraw the proposed rule on Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. As the FDA’s announcement makes clear, the agency is prioritizing corporate profits over women’s health.

Under current rules, generic drug manufacturers are not legally permitted to update drug product labels to accurately reflect known side effects or health risks because the label of generic drugs must match the label of their brand counterpart—even when there is no longer a branded equivalent on the market.

The National Women’s Health Network has advocated for the FDA to move forward with the proposed rule, which would have granted generic drug manufacturers authority to initiate safety and efficacy label changes on their own. The rule would have also required that brand and generic manufacturers update their label within 30 days after a label change request has been approved. Accurate, up-to-date generic drug labels are critical to ensuring the health and safety of women. As it currently stands, a woman may have no idea that the generic drug she is taking could cause devastating complications.

“Women deserve the same access to good information regardless of whether they’re prescribed generic or brand-name drugs,” said Cindy Pearson, Executive Director of the National Women’s Health Network. “By bowing to corporate pressure, the FDA has put women at risk.”

The National Women’s Health Network is supported by our members and by choice we do not accept financial support from drug companies or medical device manufacturers. We bring the voices, concerns and needs of women consumers to policy and regulatory tables.

Cindy Pearson was the NWHN’s Executive Director from 1996 to 2021. One of the nation's leading advocates for women's health, Cindy often testified before Congress,  NIH and the FDA and was frequently featured in the news as a consumer expert on women’s health issues. When she retired, Cindy received a Congressional Resolution in honor of her outstanding contributions to the health of women and girls.

Read more from Cindy Pearson.