E&C Panel Clears FDA User Fee Bill As Lawmakers Continue Negotiations

Members of the House Energy & Commerce health subcommittee on Wednesday (May 11) voted 30-0 to send their comprehensive user fee legislation to the full committee with no amendments, though lawmakers did raise concerns they hope to resolve before the full committee markup next week. Subcommittee Chair Anna Eshoo (D-CA) took issue with provisions that clarify FDA’s authority over certain medical devices and contrast agents, and lawmakers made clear they still haven’t reached an agreement on whether to include legislation...
Article Type: 
Site Name: 
InsideHealthPolicy.com
FDA Issue: 
FDA Week - 05/13/2022
FDA Volume: 
Vol. 28, No. 19
Author: 


HHS Tells Govs To Step Up Post-PHE Plans But Mum On End Date

The Biden administration on Tuesday (May 10) pressed governors to get serious about planning for the end of the public health emergency -- including the restart of Medicaid enrollment determinations and decisions on which state pandemic flexibilities to continue -- but said the administration has yet to decide whether to extend the PHE beyond mid-July. The letter, sent just days before HHS would need to give its promised 60 days’ advance notice of a PHE end , sparked mixed reactions...
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Tags: 
Site Name: 
InsideHealthPolicy.com
CMS Issue: 
Inside CMS - 05/19/2022
CMS Volume: 
Vol. 25, No. 20
HEA Issue: 
Health Exchange Alert Weekly Report - 05/18/2022
HEA Volume: 
Vol. 10, No. 20

Advocates Urge HHS To Renew Public Health Emergency

Hospitals, providers, nursing homes and children’s health advocates are begging the Biden administration to extend the public health emergency though October, arguing COVID-19 variants will run rampant without the flexibilities made available during the PHE, including the Medicaid renewals freeze and FDA’s emergency use authorizations for new vaccines, tests and treatments. HHS Secretary Xavier Becerra extended HHS’ public health emergency on April 12 through mid-July . The administration has promised to give states and stakeholders 60 days’ notice before letting...
Article Type: 
Site Name: 
InsideHealthPolicy.com
CMS Issue: 
Inside CMS - 05/19/2022
CMS Volume: 
Vol. 25, No. 20
HEA Issue: 
Health Exchange Alert Weekly Report - 05/18/2022
HEA Volume: 
Vol. 10, No. 20










Moderna, Consumers Rely On Same Patent Law For Cross Purposes

Moderna is relying on the same patent law provision to fend off an infringement lawsuit that consumer lobbyists recommend the government use to authorize production of generic versions of six brand drugs. Arbutus Biopharma and Genevant Sciences filed a lawsuit ( case no.: 1:22-cv-00252 ) that alleges Moderna used an Arbutus-patented component in Moderna’s coronavirus vaccine without permission. Arbutus developed and patented lipid nanoparticles that Moderna uses to protect and help deliver the messenger RNA in its vaccine, the complaint...
Article Type: 
Site Name: 
InsideHealthPolicy.com
IDP Issue: 
Inside Drug Pricing - 05/16/2022
IDP Volume: 
Vol. 5, No. 20
Author: 

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