G2G Bio Bulletin – October 19, 2026
Updates from Washington
Congress: Both chambers are out of session until after the election, and activity is limited.
- Senate Finance Committee Democrats released a request for information (RFI) to gather advice on policy improvements in aged care.
Administration & Agencies:
- FDA
- The agency has announced the Rare Disease Framework Initiative which aims to accelerate approvals of drugs addressing rare conditions. Notably, the framework seeks to incorporate patient input prior to the conclusion of clinical trials and facilitate more tailored approaches to regulatory review. A hybrid meeting to seek public input on the plan is scheduled for October 28.
- CMS:
- The agency has issued a proposed rule, with a comment period open until December 15, that would:
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Require Medicare Advantage plans to verify and update provider directories every 90 days.
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Eliminate copays for generic drugs for seniors who are at or below 100% of the Federal Poverty Level from January 2028.
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Require pharmacy benefit managers (PBMs) to report on their compensation, cost performance, and other data.
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Five Democratic governors have written to HHS Secretary Kennedy asking for more time to implement OBBBA Medicaid work requirements that are required go into effect January 1, citing the limited runway following the release of the CMS implementation rule in June.
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- The agency has issued a proposed rule, with a comment period open until December 15, that would:
- White House, Other HHS Agencies & Departments:
- ACA: HHS is being sued by a group representing insurance brokers, to reverse a ban, announced last month, on new brokers from registering on ACA exchanges.
- Federal Rulemaking: Following recent setbacks in court, the Administration has asked the Supreme Court to weigh in on the validity of lower courts citing violations of the Administrative Procedure Act to nullify federal rules.
Reminder
Don’t miss the monthly GBG Report call every third Thursday of the month at 12 pm ET where the G2G team discusses the latest federal life sciences funding opportunities. G2G has raised $624M and is eager to share our expertise to help companies grow and accelerate bringing innovations to patients.