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Coronavirus Response

Eyes On FDA As Trump, Docs Press Agency To Reissue Hydroxychloroquine EUA

Stakeholders are closely watching to see whether FDA will cave to pressure from the White House and doctors and reinstate emergency use authorization for the anti-malarial drug hydroxychloroquine.

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Joe Biden would direct Medicare to negotiate prices of drugs that face little competition, using international prices as a reference, and the negotiated prices would be available to public and private insurers, according to the presumptive Democratic presidential nominee’s platform.

Republican lawmakers on the House Ways & Means Committee will soon introduce four bills aimed at providing additional incentives and tax benefits for pre-revenue companies, start-up businesses and partnerships that are focused on infectious disease drug development, committee staff members told reporters on a press call Wednesday (July 8).

The White House Office of Management and Budget last week completed its review of FDA’s draft guidance on quality considerations for clinical research on cannabis.

HHS’ lead COVID-19 testing official says social distancing, wearing a mask and good hygiene will do more to stop the pandemic in the United States than testing, coming as leading congressional Democrats allege a lack of administration leadership and faulty policies have caused tests to be rationed and prevented widespread testing of asymptomatic individuals.

The Association for Behavioral Health and Wellness called on CMS to continue to allow telehealth flexibilities for behavioral health services beyond the pandemic, but to also closely study the efficiency of such services, in a letter sent to CMS Administrator Seema Verma on Monday (July 6).

Novavax will receive $1.6 billion from HHS to make its COVID-19 vaccine candidate, and Regeneron Pharmaceuticals will receive $450 million to scale up production of its antibody candidate, HHS announced on Tuesday (June 7).

Federal guidance calls for nursing home staff to be tested for COVID-19 at least once a week, but most nursing homes are waiting so long for results that testing is not an effective way to control the coronavirus’ spread and facilities also can’t afford to test everyone, an American Health Care Association survey of its members found.

Dozens of House and Senate lawmakers from both parties are urging HHS to send additional CARES Act funding to children’s hospitals, which they say have not received the same financial support as other providers that are struggling due to the COVID-19 pandemic.

Trump administration officials told a Senate Appropriations panel that reported moves by several COVID-19 vaccine and drug developers to eliminate “march-in” language from their contracts with HHS should not lead to price gouging.

The House Appropriations agriculture subcommittee on Monday (July 6) agreed by voice vote to send a draft fiscal 2021 FDA funding bill to the full committee that would give FDA an increase of $40.8 million dollars over fiscal 2020 funding levels, for a total of $3.21 billion in discretionary funding, yet slightly less than the increase proposed by the White House.