April 24, 2019 | Access to Medicines


Trump Administration Calls for Regulation Change to Unilaterally Disarm Government’s Strongest Existing Tool to Curb High Drug Prices

Brittany Herrick (Health GAP): 347-263-8438| brittany@healthgap.org

Brook K. Baker, Professor of Law at Northeastern University School and Senior Policy Analyst at Health GAP, issued the following statement:

“The National Institute of Standards and Technology (NIST) of the Department of Commerce released a final ‘Green Paper’ called Return on Investment Initiative to Advance the President’s Management Agenda. This document proposes drastically narrowing the circumstances in which government can authorize generic competition to lower drug prices, showing the Trump Administration is more interested in appeasing pharmaceutical corporations than in using the strongest existing statutory authority to rein in high drug prices.  

“The two key recommendations in the final paper seek regulatory redefinitions that will limit government use licenses and eliminate ‘march-in rights’ in response to excessive pricing. This would undermine two existing policy tools that should be used to rein in high drug prices domestically.  These recommendations, if adopted, would result in regulations specifying (1) that the government has very narrow rights to issue non-commercial, public use licenses—in the instance of direct government use, consumption or provision only, for example for the Department of Veterans Affairs or for Department of Defense drug purchases, rather than use ‘by or for’ the government such as for Medicare or Medicaid programs and (2) that government-funded research should be transferred to private industry free of pricing condition, ensuring that governments and the public pay twice—first for foundational research and second for the bloated prices charged by the beneficiaries of these same government-funded inventions. The proposals in the Green Paper would be accomplished by regulation rather than by legislation, thus tying the government’s hands without Congressional action. Congress would be limited to possible legislative override in the distant future.

“Leaders in Congress on both sides of the aisle should undertake hearings to deter these harmful, price-escalating regulatory changes and to advance efforts that would increase the government’s power to use competitive licensing to combat unacceptably high drug prices.

“This policy move yet again reveals the hypocrisy of the White House on pharmaceutical pricing.  Presidential candidates should reject these drastic restrictions as the pharma giveaways that they are. Instead, they should respond to widespread public anger over high drug prices and to the grave harm they cause with real pricing reforms. Moreover, they should pledge to prevent the exportation of these harmful policies abroad, through trade deals or other means.”


Health GAP is an international advocacy organization dedicated to ensuring that all people living with HIV have access to affordable life-sustaining medicines. Our team pairs pragmatic policy work with audacious grassroots action to win equitable access to treatment, care and prevention for people living with and affected by HIV worldwide. We are dedicated to eliminating barriers to universal access to affordable life-sustaining medicines for people living with HIV/AIDS as key to a comprehensive strategy to confront and ultimately stop the AIDS pandemic. We believe that the human right to life and to health must prevail over the pharmaceutical industry’s excessive profits and expanding patent rights.