Rx Roundup | FDA & Beyond - 6/26

研报英文原文证据摘录

Rx Roundup | FDA & Beyond - 6/26

TD Cowen

Global Research June 26, 2026

June 11, but manufacturers have until July 17 to finalize a participation agreement. The

deadline for states to apply for access to the pricing is September 10. There has been

speculation that voluntary participation has been low given that the deadline had been

repeatedly extended, though the Trump admin maintains there has been high enthusiasm

for GENEROUS. “The government of the United States also expects that, if the GLOBE and

GUARD Models are finalized, companies will make use of the provisions in those models

to mitigate the risks of launching new medicines in lower priced countries.” CMS also

commits that demonstration projects that use international drug pricing benchmarks will

not “uniquely disadvantage” the United Kingdom under its current drug pricing system.

“The United States and the United Kingdom expect to work together so that pharmaceutical

companies do not delay the launch of their innovative medicines in the United Kingdom.”

■FDA Senate appropriations stalled. A mark-up of the Agriculture/FDA Appropriations

bill by the Senate Appropriations Committee was announced for June 25 and then

almost immediately postponed. With Sen. Mitch McConnell (R-KY) currently hospitalized,

Republicans on the committee lack a majority, and Democrats have not agreed to support

any pending bills. The FDA mark-up was first scheduled for June 4 but has been in limbo

ever since. The House cleared its version of the FDA/Ag bill at the start of June. There are no

plans to reschedule, and this could drag into the fall.

■FY 2027 National Defense Authorization Act (NDAA)/China. There are multiple

amendments championed by the National Security Commission on Emerging Biotechnology

(NSCEB, the bipartisan U.S.