In final rule describing the types of evidence the agency will consider in determining the ‘intended use’ of a product, FDA rejects industry requests to exclude ‘circumstances surrounding distribution’ and product design or composition.

Legislation to prevent pay-for-delay deals, product hopping and sham citizen petitions, and to require the FTC to study the role of pharmacy benefit managers in the drug supply chain get unanimous committee vote. They may have a good shot at passage given recent actions by President Biden and the FTC, and bipartisan interest in drug pricing.

They may have a good shot at passage given recent actions by President Biden and the Federal Trade Commission, and bipartisan interest in drug pricing. 

The shingles vaccine could potentially be used in about three million immunocompromised people, according to GSK, but CDC’s advisory committee will weigh in with recommendations.

Benefits of the one-shot vaccine outweigh risk, ACIP members agree. One member says he supports its availability but would personally recommend mRNA vaccines instead.

NY AG has ‘no comment’ on whether criminal charges will be pursued against company executives; NC AG predicts ‘north of 40 states’ expected to accept settlement and would then need to convince municipalities to come on board. States with ongoing litigation against manufacturers may opt for jury trial instead.