Policy Updates

Your Generic Drug Label Doesn’t Tell You EVERYTHING

Publication Date: August 15, 2015

By: Cindy Pearson

Last week we attended a public meeting at the Food and Drug Administration (FDA) where we testified in front of supporters and opponents on behalf of the FDA’s proposed rule on Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products.

The proposed Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products by the Food and Drug Administration (FDA) grants generic drug manufacturers authority to independently initiate safety and efficacy label changes. The rule also requires brand and generic manufacturers to update their labels within 30 days after a label change request has been approved – great news for women and public health.

In 2011, the U.S. Supreme Court ruled that generic brand labels must match the labels of their brand counterpart. This ruling prevents generic manufacturers from updating their labels even when they know the information is outdated or incorrect. As it currently stands, a woman may have no idea that the generic drug she is taking could cause devastating complications. This is important because more than 80% of all prescriptions filled in the U.S. are for generic drugs. The medication you reach into your cabinet for every morning may have outdated safety, dosing, and efficacy information.

The National Women’s Health Network understands that women need updated safety and efficacy information to make informed decisions for themselves and their families — and that’s why we will continue urging the FDA to adopt this rule expeditiously.

If you have experienced a side effect or contraindication that was not listed on the label of your generic drug, we would love to hear from you! Please take a moment to share your story with us at [email protected] and help raise awareness on this important issue.

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.

Get Involved

New ways to empower health care consumers across the nation.