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PRESIDENT TRUMP SIGNS $8.3 BILLION CORONAVIRUS FUNDING BILL

March 6, 2020 in Life Sciences News Public Policy by admin

Today, President Trump sign a $8.3 billion emergency coronavirus funding measure, after it cleared both the House and Senate earlier in the week. View a summary of the legislation here. The bill would provide funding for diagnostics, treatments, and the purchase of medical supplies. Highlights include:

Food and Drug Administration – $61 million to facilitate the development and expedite review of medical devices, therapies, and vaccines to combat the coronavirus.

Department of Health and Human Services (HHS) – more than $3 billion for research and development of vaccines, therapeutics, and diagnostics – including more than $2 billion in funding for HHS’ Biomedical Advanced Research and Development Authority (BARDA) and more than $800 million for the National Institutes of Health (NIH).

Centers for Disease Control and Prevention – $2.2 billion to support federal, state, and local public health agencies; $950 million, of which $475 million will be available to States within 30 days to conduct public health activities. A state would receive a minimum of $4 million.

As reported in Politico, to address concerns about patient access and affordability, language was included requiring that vaccines, therapeutics, and diagnostics developed using taxpayer funds be available for purchase by the federal government at a “fair and reasonable price”. Authority is also given to the HHS Secretary to ensure similar affordability in the commercial market.

Some Democrat lawmakers had pushed for stronger pricing language, proposing to remove intellectual property protections for vaccines and therapies if the price was determined to be too high. The effort was ultimately sidelined over concerns that the language could impede critical research and development. However, Democrat progressives continued to push for stronger pricing constraints, holding a press conference, as reported in Stat News, shortly after House passage of the emergency spending bill. In addition to price controls, they called for “open licenses” for drugs developed by the NIH and creation of an independent committee to set the price for any drug created using federal research.

Unfortunately, lawmakers did not include a provision that would have provided liability protections for device manufacturers, including for medical mask manufacturers.