CAGW to HHS: Say No to State AGs Demands | Citizens Against Government Waste

CAGW to HHS: Say No to State AGs Demands

The WasteWatcher

On August 4, 2020, state attorneys general (AG) from 31 states, the District of Columbia and two U.S. territories, led by California Attorney General Xavier Becerra and Louisiana Attorney General Jeff Landry, wrote a letter to Health and Human Services (HHS) Secretary Alex Azar, National Institutes of Health (NIH) Director Francis Collins, M.D., and Food and Drug Administration (FDA) Commissioner Stephan Hahn, M.D., demanding that the government steal the patent for remdesivir from its inventor Gilead, a biopharmaceutical company.  Citizens Against Government Waste (CAGW) sent a letter today to Secretary Azar, Director Collins, and Commissioner Hahn asking them to reject the AGs proposal.

The law that the AGs are invoking, known as the Bayh-Dole Act, allows research entities that receive federal funding to own the patent and license the rights to a private sector collaborator that would take the risk and expense to commercialize them.  “March-in rights” could be used in only specific circumstances, like when the private sector collaborator had not commercialized the invention.

Not only has the government never used this power, Gilead created and developed the drug as an antiviral drug in 2009 at its own expense in an effort to fight hepatitis C.  It was not effective for that disease.  When Ebola was spreading in Africa in 2014, Gilead worked with NIH to see if remdesivir would be a potential treatment for that disease, but another therapy was found to be more effective.  Additional research was conducted to see if it would work against coronaviruses SARS and MERS, which showed promising results. 

When COVID-19 broke out across the world, Gilead worked with many countries and NIH to see if remdesivir would be an effective treatment for patients.   Results were promising, and the company received emergency use authority from the FDA, since it is not an approved drug, to treat only hospitalized patients.  It was found to be effective in reducing patients’ hospitals stays and hastening recovery from COVID-19.  The company is expecting to invest more than $1 billion this year in expanding its manufacturing capacity and researching to see if an inhaled solution, as opposed to its current intravenous administration, would be an effective treatment.

CAGW agrees with Gilead’s statement that the AGs have a “fundamental lack of understanding of how remdesivir is being used to treat patients” and that the “use of ‘march-in’ rights under the Bayh-Dole Act will do nothing to produce additional doses of remdesivir this year and will discourage other manufacturers from investing in the development of new therapies and vaccines that hold the potential to better treat and one day eliminate COVID-19, as well as meet the challenges of future pandemics.”

CAGW is particularly disturbed that nine Republican AGs also signed the letter, since one would presume they would respect intellectual property rights, reject socialist policies being proposed by Sens. Bernie Sanders (I-Vt.) and Elizabeth Warren (D-Mass.), and not adopt communist China’s or India’s modus operandi of stealing intellectual property, especially for pharmaceuticals.  Unfortunately, lately too many Republicans who claim they believe in capitalism, free markets and a private healthcare system are straying far from these beliefs by espousing government-run healthcare procedures.

The initial response from HHS to the AGs letter was a statement expressing opposition to the request to exercise march-in rights.  A strong, formal statement from HHS, NIH, and the FDA is necessary as soon as possible to both reject the request as inappropriate and illegal, and make it clear that any future effort to steal a company’s intellectual property under the Bayh-Dole Act would also be fruitless.

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