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States vs FDA: When Can They Go It Alone On COVID Shots, Treatments?

 
• By Sarah Karlin-Smith

Two GOP governors are talking about using COVID products in ways not authorized by the US government. But the different paths they are taking could lead to different enforcement approaches by the feds – as well as different political outcomes for the governors.

covid us map
States interest in administering additional COVID shots present a maze of legal questions. • Source: Alamy

Gov. Larry Hogan, R-Md., said 20 January that his state was working on a study to see if nursing home residents and adults living in other congregate facilities needed an additional or fourth booster dose of COVID-19 vaccines and that he was willing to administer them without the US Food and Drug Administration or the Centers for Disease Control and Preventions endorsement.

“I think the federal government is talking about those things now, and we hope they will make a decision on it,” said Hogan

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What The EMA Can Teach HTA Bodies About Joint Clinical Assessments

 
• By Francesca Bruce

EU-level joint clinical assessments conducted under the Health Technology Assessment Regulation need to be more flexible when it comes to evidence requirements, according to experts speaking at a gene and cell therapy conference.

Moderna Pivots To Increase Focus On Cancer Amid US Vaccine Policy Changes

 
• By Joseph Haas

During its first quarter earnings call, Moderna avoided criticizing vaccine policy changes, but de-emphasized its flu/COVID-19 vaccine for those under age 50 and prioritized cancer programs.

What MAHA Means For US FDA: Prevention Is Not What You Think

 
• By Michael McCaughan

US HHS Advisor Calley Means said new pathways for root-cause treatments are part of the HHS Secretary Robert F. Kennedy Jr.’s vision for the FDA. But what most biopharma companies consider preventative medicines are not what he has in mind, nor does he seem to see those companies as part of the solution.