Major drug pricing regulation moves forward
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A regulation with potentially major implications for the pharmaceutical industry has cleared its review, teeing it up for imminent proposal should the Trump administration decide to move forward.
Why it matters: The regulation, which appears to tie what the U.S. pays for some drugs to the prices in other countries, would be the administration's most aggressive step yet to lower U.S. drug prices.
- The so-called most-favored-nation regulation would also have enormous financial implications for manufacturers.
Driving the news: The proposed regulation, titled the "Global Benchmark for Efficient Drug Pricing (GLOBE) Model," completed review on Wednesday, according to OMB's website.
- The listing notes the proposal is "economically significant."
Details: It's unclear what exactly the proposal would do, but there has been widespread speculation by lobbyists and analysts that it could resemble the first Trump administration's attempt to tie prices in Medicare Part B to foreign prices through a Centers for Medicare and Medicaid demonstration model.
The big picture: The White House announced a series of pricing deals with individual pharmaceutical companies throughout the fall.
- Those deals featured pricing concessions within Medicaid, commitments that future U.S. launch prices will be on par with those in other countries, and participation in a government platform for selling drugs directly to consumers.
- The duel threats of regulation and tariffs were the background to those deals, but the administration has never said most-favored-nation regulations for the whole industry were off the table.
What we're watching: Whether CMS announces it is indeed moving forward with the rule.
