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Three Questions for NIH Nominee Bertagnolli

Washington, D.C. – On Wednesday, the U.S. Senate Committee on Health, Education, Labor and Pensions (HELP) will hold a hearing on President Biden’s nominee, Dr. Monica Bertagnolli, to head the National Institutes of Health (NIH). U.S. Senator Bernie Sanders (I-Vt.), chair of the HELP committee, had placed a several-month hold on the hearing pending commitments from the Biden administration to further lower drug prices. Sanders announced the confirmation hearings would proceed in response to the Biden administration including a clause limiting high prices in a recent funding agreement with Regeneron.

“NIH cannot avoid responsibility for the extraordinary prices of the medicines it supports,” says Peter Maybarduk, director of the Access to Medicines program at Public Citizen. “Currently, corporations largely enjoy the benefits of public research while gouging the public on the medicines subsequently developed, and perpetuating gross inequalities worldwide. The next NIH director must address the untethered monopoly power of corporations by putting more conditions on public research grants.”

While U.S taxpayers subsidize the innovation of drugs globally, Americans frequently pay some of the highest drug prices in the world, while publicly funded medicines can be inaccessible to people in low- and middle-income countries, as the world witnessed during the COVID-19 emergency. A recent study by HELP committee majority staff found that the median price of new treatments that NIH scientists helped invent over the past twenty years is $111,000.  The NIH is the largest public funder of biomedical research in the world, investing $45 billion in U.S. taxpayer dollars annually. Publicly supported research has proven critical to the late-stage development of 1 in 4drugs.

Public Citizen has outlined three questions  that senators should ask Dr. Bertagnolli to advance NIH accountability to taxpayers:

  1. Will you ensure that NIH collaborations with pharmaceutical companies protect the public by including reasonable pricing and access safeguards from their outset? Agreements between public funders and drug companies have provided billions of dollars to industry with few substantive conditions attached. The NIH must build on the Biden administration’s lastest conditioning of critical public support to industry on reasonable pricing and access to medicines, particularly for Project NextGen, which will provide a colossal $5 billion to industry to advance new vaccines and treatments.
  2. Will you support routinely licensing technologies invented by government scientists and through taxpayer funds to health and humanitarian organizations like the Medicines Patent Pool in order to promote access to life-saving medicines in low- and middle-income countries? Infectious diseases know no border, and failing to tackle access abroad gives rise to devastating consequences domestically. Last year, the Biden Administration entered an agreement with the MPP for several NIH-owned technologies related to COVID-19. But Moderna’s exclusive control of the vaccine NIH co-invented led to rationing and high prices.
  3. Will you protect and leverage march-in and royalty free rights to promote affordability and protect taxpayer investments in the development of drugs? The Bayh-Dole Act provides public funders of inventions certain rights to protect the public interest when taxpayers provide grants under which inventions are made. These safeguards include march-in rights, which allow agencies like the NIH to license patents on inventions made through a government grant to other manufacturers under certain conditions. Agencies also retain royalty-free rightson publicly funded inventions.

Read the full backgrounder, “Key Questions for the National Institutes of Health Director Nominee”.