User Fee Bill Requires Sponsors To Submit Trial Diversity Plans To FDA

House lawmakers’ draft user fee legislation includes several measures aimed at increasing diversity in clinical trials, including a requirement that drug and device sponsors provide FDA with diversity action plans that lay out their trial enrollment goals and explain how they plan to meet those goals. The legislation also calls for FDA to issue draft guidance on trial diversity plans and decentralized clinical trials, provide a public report summarizing the diversity action plans, and hold a public meeting on trial...
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InsideHealthPolicy.com
FDA Issue: 
FDA Week - 05/06/2022
FDA Volume: 
Vol. 28, No. 18
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Antibiotic Incentives, LDT Reform Left Out Of E&C’s Draft User Fee Bill

The House Energy & Commerce Committee on Wednesday (May 4) unveiled a draft user fee reauthorization package that addresses several hot-button issues, including FDA’s accelerated approval pathway and inspection authorities , but missing from the legislation are measures to incentivize antimicrobial drug development and give FDA authority over laboratory-developed tests. Key lawmakers have introduced antimicrobial drug and LDT legislation and have indicated they would like to get them passed with a larger legislative vehicle. Both issues have been a key...
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Site Name: 
InsideHealthPolicy.com
FDA Issue: 
FDA Week - 05/06/2022
FDA Volume: 
Vol. 28, No. 18
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ASPE: COVID Vaccines Saved $2.6B By Cutting Medicare Hospital Stays

HHS’ Assistant Secretary for Planning and Evaluation released an analysis Wednesday (May 4) that found COVID-19 vaccinations saved $2.6 billion due to 107,000 fewer hospitalizations among Medicare beneficiaries during the first five months of 2021, and Medicare beneficiaries’ out-of-pocket costs were estimated to have dropped by $207 million. “The total hospitalization cost savings from this early vaccination period were nearly large enough to offset the cost for approximately 67.7 million single doses of J&J or 31.2 million two-dose series of...
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InsideHealthPolicy.com
CMS Issue: 
Inside CMS - 05/12/2022
CMS Volume: 
Vol. 25, No. 19
Author: 

House User Fee Bill Combines Dem, GOP Accelerated Approval Reforms

House lawmakers’ draft user fee reauthorization package, unveiled Wednesday (May 4), brings together proposals from Democrats, Republicans, FDA and industry to make changes to the agency’s accelerated approval pathway. The draft would give the agency authority to require sponsors of accelerated approval drugs begin conducting postmarket studies when drugs are approved, establish labeling requirements for the drugs, make clear that real-world evidence can be used to support postmarket studies, and require FDA to work with industry to identify endpoints that...
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Site Name: 
InsideHealthPolicy.com
FDA Issue: 
FDA Week - 05/06/2022
FDA Volume: 
Vol. 28, No. 18
Author: 

User Fee Reauthorization Package Boosts FDA Inspection Authority

FDA inspectors would gain additional authority, including the ability to use remote tools in place of some traditional inspections and increase unannounced foreign inspections, under the draft user fee reauthorization legislation unveiled by the House Energy & Commerce Committee Wednesday (May 4). E&C health subcommittee Chair Anna Eshoo (D-CA) and ranking Republican Brett Guthrie (KY) plan to formally introduce the legislation by Friday (May 6), and the health subcommittee will mark up the bill next week. The bill, the Food...
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Site Name: 
InsideHealthPolicy.com
FDA Issue: 
FDA Week - 05/06/2022
FDA Volume: 
Vol. 28, No. 18
Author: 

Insurers Ramp Up Lobbying On ARP Subsidies

Insurers and other stakeholders are ramping up pressure on Congress to extend the enhanced Affordable Care Act (ACA) subsidies enacted under the American Rescue Plan by July to stop millions of people from facing significant premium increases or lost coverage when the extra subsidies expire Jan. 1. Over the last week, insurance lobbies have released reports on the impact of not extending the credits, as surveys show wide-ranging support for making the subsidies permanent, joined other key health care lobbies...
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InsideHealthPolicy.com
CMS Issue: 
Inside CMS - 05/12/2022
CMS Volume: 
Vol. 25, No. 19
HEA Issue: 
Health Exchange Alert Weekly Report - 05/11/2022
HEA Volume: 
Vol. 10, No. 19
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