On this week’s episode of “The Readout LOUD”: a closer look at the NIH’s grant-cutting legal playbook, a not-so-transparent transparency push by the FDA commissioner, and another big biotech acquisition.
Our colleague Anil Oza joins us to unravel a previously unseen memo he obtained from HHS that lays out the legal framework being used to justify the termination of NIH grants. The disclosure comes as legal fights over the legitimacy of these funding cuts are being challenged in multiple courts.
But first, we raise some skeptical eyebrows about FDA Commissioner Marty Makary’s decision to publish hundreds of letters the agency sent to drugmakers when it rejected their medicines. Makary called the action another example of the FDA’s push to be radically transparent about drug reviews, but outsiders noted that these letters only pertained to drugs that were eventually approved, rendering the information they contained somewhat moot. And Makary has not yet committed fully to release so-called complete response letters for drugs rejected under his watch.
We also discuss this week’s announcement that Merck intends to acquire Verona Pharma for $10 billion — another sign that biotech M&A activity is heating up as large pharma companies search for new revenue sources.
For more on Anil Oza’s NIH coverage, click here and here. STAT’s coverage of the FDA can be found here, and a story discussing the Merck-Verona deal is here.
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