[Bayh-dole-regulations] First 100: The Day One Agenda Has Stalled Out - The American Prospect

James Love james.love at keionline.org
Sat Apr 3 20:40:47 PDT 2021



Another really powerful option for a president is to use “march-in rights”
on prescription drugs that were developed with public support. The
Bayh-Dole Act of 1980 allows the Health and Human Services Department to
“march in” if those drugs aren’t being offered to the public on “reasonable
terms,” with affordability being one of those terms, and then seize the
patents, redistributing them to companies who will lower the prices for

As Lee Fang writes today, the Trump administration engaged in an effort at
the National Institute of Standards and Technology (NIST) to modify the
Bayh-Dole Act’s rules in a way that would eliminate march-in rights based
on high drug prices. Incredibly, this rulemaking was not frozen when the
Trump administration ended, and it’s still open for public comment, which
means it’s moving toward being finalized.

Drug company lobbying has routinely blocked the use of march-in rights, but
this obviously represents an escalation, by preventing such use ever in the
future. Lobbyists have been working hard to get the NIST rule across the
finish line, even in a Democratic administration. House and Senate
Democrats have called on the White House to revoke the rule.

Not only did current Health and Human Services Secretary Xavier Becerra
call for using march-in rights just last year to lower the cost of
coronavirus drug remdesivir, Vice President Kamala Harris made march-in
rights a major policy feature of her campaign. Presumably she would be
interested in the fact that the administration she serves in is about to
wipe this option out.

So not only is Biden not using the Day One Agenda to anything approaching
its fullest potential, on one key piece he’s poised to roll it back. People
should express their displeasure at this.

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