> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# WLF Again Rejects Unilateral Label Changes
- URL: https://www.fdaweb.com/wlf-again-rejects-unilateral-label-changes/
- Published: 2016-04-26T12:00:00.000Z
- Updated: 2026-09-14T20:57:21.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135502

Believing from media reports that FDA is nearing a decision on its proposal to amend regulations governing procedures for application holders of an approved drug or biologic product to make unilateral changes in the product labeling, Washington Legal Foundation has [reiterated](https://www.regulations.gov/contentStreamer?documentId=FDA-2013-N-0500-0138&attachmentNumber=1&disposition=attachment&contentType=pdf&ref=fdaweb.com) its objection to the proposal and its support for an alternative suggested by the Generic Pharmaceutical Association and Pharmaceutical Research and Manufacturers of America. The alternative would make FDA the source of uniform labeling across the industry.

WLF says that the FDA proposal violates a fundamental principle of the Waxman-Hatch Act that because generic drugs are identical to the referenced branded drug in every pertinent respect, generic drug companies are permitted to rely on safety and effectiveness data developed by innovator companies in their original NDA filings and need not compile their own data. Congress, WLF says, has determined that if the “sameness” principle were not in effect and generic drug manufacturers were permitted to make unilateral changes in product labeling, there would not be any justification for excusing the generic manufacturers from conducting the extensive product testing needed to verify labeling information.

Also, WLF says, FDA’s authority under the Federal Food, Drug, and Cosmetic Act does not include the power to issue regulations that countermand an explicit provision of the law. The interest group predicts that the proposal as it stands would be unlikely to survive a court challenge. It also says that the proposal is likely to lead to unnecessary confusion and uncertainty for doctors who must decide whether a drug is appropriate for their patients, and will expose generic manufacturers to product liability litigation.

The letter says that WLF supports the alternative proposal because it would accomplish the agency’s stated goals, would have no negative market effects, and falls comfortably within FDA’s statutory authority.