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 Among these actions, the most significant was the issuance of a revised draft guidance on citizen petitions subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act (“FDCA”), published on the same day.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 ...
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Recent Updates
- Federal Embryo Adoption Program Raises Potential Legal Questions for Reproductive Health
- Vermont’s H. 583 Restricts Private Equity and Hedge Funds with Ownership and Controlling Interests from Interfering with Clinical Judgment of Health Care Providers
- DOJ’s Second National Health Care Fraud Takedown of the Second Trump Administration Heavily Targets Medicaid Fraud
- FDA Regulations to Establish Minimum CGMP Requirements for Manufacturing, Packaging, Labeling, and Holding of Dietary Supplements
- OIG Advisory Opinion 26-14 Offers Another Favorable Path for Patient Access Through Sponsored Testing