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Drug Pricing Debate Surfaces at NIH Nominee's Confirmation Hearing

The continuing debate as to where to draw the line between encouraging innovation and lowering drug costs was front and center during a Senate HELP Committee confirmation hearing for NIH director nominee Monica Bertagnolli. For decades, NIH has funded and supported research and innovation that has been critical for the development of many pharmaceutical products and other therapies. But, as drug costs have continued to increase, certain policymakers, including HELP Committee Chair Bernie Sanders, have argued that NIH should aggressively use reasonable pricing contract clauses or march-in rights under the Bayh-Dole Act in order to undermine patents to lower drug prices for products that were developed with NIH's assistance.

During the hearing, Bertagnolli was pushed by both sides of the debate. Although Senator Sanders pushed for NIH to play an aggressive role to reduce drug prices, Senator Bill Cassidy pushed back, pointing to the removal of reasonable pricing contract clauses during the Clinton administration in response to concerns that such clauses were stifling innovation and collaboration. Senator Cassidy also asserted that march-in rights are not intended to be used to reduce drug costs. Throughout the hearing, Bertagnolli tried to walk a fine line by discussing the importance of reducing drug costs but not committing to specific actions that she would take at NIH.

We will see in the coming weeks whether Bertagnolli will be confirmed as the next director of NIH, but the debate over whether NIH should play a role in reducing drug costs is sure to continue.    

“I can say that I myself believe that the American people deserve a fair return on the investment that Congress has placed within the National Institutes of Health and the research that we do. And I will commit to working to make sure that the benefits of our research are affordable and available to all the American people. I cannot give specifics at this time about the execution of that plan,” Bertagnolli said when asked by Sanders if she would reinstate and expand the use of reasonable pricing clauses which NIH removed from its model Cooperation Research and Development Agreement (CRADA) in 1995.


intellectual property, pharma