Hundred dollar bills rolled up in a pill bottle

Reasonable Pricing Clauses: A First Step Toward Ensuring Taxpayers a Fair Return on their Public R&D Investment

By Nikhil Chaudhry and Reshma Ramachandran

Earlier this month, the Department of Health and Human Services announced that it had successfully included a reasonable pricing provision in a $326M investment contract with Regeneron for development of a next generation monoclonal antibody therapy for COVID-19. This was the first time the Biden Administration had included such a provision as part of its research funding agreements with the private sector, demonstrating that it is indeed possible for the federal government to negotiate deals with pharmaceutical companies that ensure that products developed with public dollars are priced comparably to the global market.

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BETHESDA, MD - JUNE 29, 2019: NIH NATIONAL INSTITUTES OF HEALTH sign emblem seal on gateway center entrance building at NIH campus. The NIH is the US's medical research agency.

Will NIH Learn from Myriad when Settling Its mRNA Inventorship Dispute with Moderna?

By Jorge L. Contreras

The National Institutes of Health (NIH) is currently embroiled in a dispute over the ownership of patent rights to Moderna’s flagship mRNA COVID-19 vaccine (mRNA-1273).

The NIH, which funded much of Moderna’s research on the COVID-19 vaccine, should be assertive in exerting control over the results of this taxpayer-funded research. Failing to do so would be a missed opportunity for the public sector to have a say in the distribution and pricing of this critical medical technology.

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A stethoscope tied around a pile of cash, with a pill bottle nearby. The pill bottle has cash and pills inside.

What Ever Happened to NIH’s “Fair Pricing” Clause?

By Jorge L. Contreras

In the midst of the COVID-19 pandemic, calls have been made for “fair” and “reasonable” pricing of the vaccines and therapeutics that will eventually be approved to address the virus. A range of proposals in this regard have been made by members of Congress, the Trump Administration, various states, academics and civil society.

Amid this current debate, it is worth remembering the brief period from 1989 to 1995 when the U.S. National Institutes of Health (NIH) did impose reasonable pricing constraints on drugs that were developed as part of cooperative R&D agreements (“CRADAs”) between federal agencies and private industry.

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