The proposed rule grants generic drug manufacturers authority to initiate safety and efficacy label changes on their own. The rule also requires that brand and generic manufacturers update their label within 30 days after a label change request has been approved – great news for women and for public health.
In 2011, the U.S. Supreme Court ruled that generic brand labels must match the label of their brand counterpart. This ruling prevents generic manufacturers from updating their labels even when they know the information to be out of date or incorrect.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 The medication you reach into your cabinet for every morning may have outdated safety, dosing, and efficacy information.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 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.
Click here to read the testimony the Network’s Program Director, Coco Jervis submitted to the FDA last week or learn more about the proposed rule by checking out our generic drug labeling consumer health information. 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 ShareYourStory@nwhn.org 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.