Bayh-Dole Act March-In Rights Part of White House Plan to Lower Drug Prices

Following enactment of the Inflation Reduction Act, which provides for Medicare drug price negotiations, the White House has announced new actions to lower drug costs, including the release of a proposed framework for agencies to exercise march-in rights under the Bayh-Dole Act to promote public accessibility to tax-payer-funded drugs. If adopted, the framework would make it easier for the government to exercise march-in rights and would impact the value of license rights to government-funded inventions.

Read the full Alert on the Duane Morris LLP website.

PBMs Must Say Goodbye to Manufacturer Rebates

Pharmacy benefit managers (PBMs) play a significant role in U.S. drug pricing, yet their existence is little known to those outside of the pharmaceutical and insurance arenas. In an effort to modify one of the largest drivers in increasing drug costs―rebates paid to PBMs by drug manufacturers―the U.S. Department of Health and Human Services on November 20, 2020, published three final rules that, most notably, declared that these rebates are no longer protected by the safe harbors to the anti-kickback statute.

To read the full text of this Duane Morris Alert, please visit the firm website.

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The opinions expressed on this blog are those of the author and are not to be construed as legal advice.

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