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US politicians criticise cost of publicly supported antiviral drug

Democrats complain of ‘unconscionable’ prices for Covid-19 treatment, but drug maker emphasises its own investment

The US drugmaker Gilead has been criticised by two members of Congress over the price it is charging for an antiviral drug it developed, which has been authorised for the treatment of Covid-19 following clinical trials supported by public funding.

Senator Debbie Stabenow and representative Carolyn Maloney, who are both Democrats, asked the Government Accountability Office, a federal watchdog, to find out how much public money was spent on R&D for Remdesivir.

Both were critical of Gilead in their reactions to the GAO’s report, which said $162 million in federal funding supported preclinical studies and clinical trials of the drug.

In a 1 April statement that said Remdesivir costs $3,120 for a five-day course of treatment, Maloney said the GAO report provided “just the latest example of a drug company charging an unconscionable price for a drug developed with millions in taxpayer-funded research”.

Stabenow said US citizens were being “ripped off by drug companies” that “turn around and charge exorbitant prices” for drugs developed with public funding.

In addition to the $162m the GAO said federal agencies allocated between 2013 and 2020, a pre-print paper by researchers at Bentley University claimed that the National Institutes of Health spent $6.5 billion funding basic research used in developing Remdesivir.

The public funding did not result in government patent rights because it did not lead to new inventions, the GAO said.

“Gilead entered research collaborations with federal agencies and universities with a portfolio of existing patents and patent applications, including for the Remdesivir compound, which would have left little room for the agencies to generate their own patents,” the report said.

But Gilead told Research Professional News that its investment in the development of Remdesivir, marketed under the name Veklury, was much larger than the direct federal support.

“The GAO report concluded that Gilead alone funded the research that led to the company’s invention and initial synthesis of Veklury, as well as its identification of the drug’s antiviral activity against coronaviruses, prior to involvement of any external collaborations with federally funded researchers. The GAO further acknowledged Gilead’s significant investment in Veklury, which exceeded $1 billion in 2020 alone and far outweighed any limited contributions by federal agencies,” the company said.

It added that Veklury was the only antiviral medicine approved for the treatment of Covid-19 in hospitalised patients in the US, and said it was “proud of the benefits Veklury provides to patients, physicians and healthcare systems”.

The criticism came as five higher education associations—the Association of American Universities, the Association of Public and Land-grant Universities, the Council on Governmental Relations, the American Council on Education and the Association of American Medical Colleges—wrote to the National Institute of Standards and Technology (Nist) innovation agency on 5 April, asking it not to use the compulsory licensing of federally funded patents to lower drug prices.

While the associations said they “fully share the widespread public concerns about the high costs of prescription drugs”, they added that remedies to address the issue, such as the proposed broadened use of so-called ‘march-in rights’ for compulsory licensing, must not discourage “critical innovations and the ability of our institutions to transfer their discoveries to the private sector”.

Nist had requested feedback on a proposed change to rules under the Bayh-Dole Act, a 1980 US law designed to increase the licensing of patents from government-funded research.