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FTC Issues Controversial Breach Notification Rule Despite Two Commissioners’ Dissent

The Federal Trade Commission on Friday (April 26) finalized a controversial plan to extend the scope of its Health Breach Notification Rule to include personal health information collected by health apps and other technology that fall outside the Health Insurance Portability and Accountability Act, despite warnings from stakeholders the agency could be sued and dissenting opinions from two commissioners alleging FTC was overstepping its authority.

Bird Flu News

FDA, Industry Weigh Potential Pathway For Bird Flu Antigen Vaccine As Precaution

While still downplaying the potential risk to humans as testing continues after avian influenza was detected in 20% of milk sampled, administration officials Thursday (April 25) said FDA is working with industry on an appropriate regulatory pathway for rolling out vaccines made with that bulk antigen if necessary, and a vaccination prioritization plan based on responses to previous disease outbreaks is available if needed.

Latest News

Whitehouse Touts New CBO Findings On Primary Care ACOs

Senate Budget Chair Sheldon Whitehouse (D-RI) is calling to boost incentives to participate in primary care ACOs after a new CBO estimate indicated primary care ACOs, along with independently run ACOs and ACOs with higher baseline spending, are more likely to produce savings.

House Budget Committee Republicans Call For New CMMI Cost Evaluation

House Budget Committee Republicans are calling for an investigation into the Center for Medicare and Medicaid Innovation after a September Congressional Budget Office report highlighted high spending from CMMI in its first decade.

Menthol Rule Faces Indefinite Delay Despite FDA Promises

FDA’s proposed rule on banning menthol cigarettes will not be finalized in the near future, the White House confirmed Friday (April 26) after months of delays, in a decision likely tied to electoral concerns ahead of the pending 2024 presidential election, despite robust support from FDA leadership for the proposal.

Pfizer Offers Warranty Payment Approach For New Hemophilia Gene Therapy

Pfizer plans to allow payers to use a “warranty” approach to pay for its new costly gene therapy, the company announced after gaining FDA approval Friday (April 26) of Beqvez (fidanacogene elaparvovec-dzkt) for the treatment of adult patients with moderate to severe hemophilia B.