On February 1, 2023, the FTC announced a proposed $1.5 million settlement with GoodRx Holdings, based on alleged violations of the Federal Trade Commission Act (“FTC Act”) and Health Breach Notification Rule (“HBNR”) for using advertising technologies on its websites and mobile app that resulted in the unauthorized disclosure of consumers’ personal and health information to advertisers and other third parties. On the same day, the U.S. Department of Justice, acting on behalf of the FTC, filed a Complaint and Proposed Stipulated Order detailing the FTC’s allegations and the terms of the proposed settlement.
On October 2, 2018, FDA Commissioner Scott Gottlieb released a statement announcing new agency actions to further deter “gaming” of the generic drug approval process through the use of citizen petitions. Among these actions, the most significant was the issuance of a revised draft guidance on citizen petitions subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act (“FDCA”), published on the same day. The stated goal of this revision was to create a more efficient approach to 505(q) petitions and to allow the Agency to focus reviewer resources on scientific ...
Recent Updates
- DOJ, HHS Announce One-Stop Shop for Companies Voluntarily Disclosing Potential Health Care Fraud
- DOJ, HHS, CMS Launch an FCA Self-Disclosure Program for Health Care: Who Can Participate, How, and Why
- Psychedelics Move Toward the Mainstream: Lawyers’ Bird’s-Eye View from the Horizons Conference
- CMS Receives Its Exclusion Authority: What Happens Now?
- GLOBE Model Final Rule Drops — but Will It Work on a Smaller Scale?