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Potential FDA Chief Pick, Califf, Has Focused On RWE, Trial Reforms, Digital Tech

News broke Thursday (Oct. 14) that President Joe Biden is planning to nominate former FDA chief Robert Califf to again lead the agency, which would bring a familiar face back to FDA at a critical juncture -- the agency’s independence and its staff morale reportedly are low due to infighting over the pandemic response, and FDA needs to figure out how to eventually adapt to a post-COVID-19 world, which will include advancing digital technologies and processes and rethinking how clinical trials are conducted.

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House Energy & Commerce health subcommittee Chair Anna Eshoo (D-CA) introduced legislation that would establish President Joe Biden’s proposed biomedical research agency, the Advanced Research Projects Agency for Health, as a separate agency within HHS -- rather than within the National Institutes of Health as Biden has proposed -- and direct the agency to coordinate with FDA and CMS to expedite development and coverage of high-need cures.

CMS Administrator Chiquita Brooks-LaSure recently told Inside Health Policy that Medicare’s current authority to provide dental care is limited and indicated the agency has no plans to expand the administration's interpretation of what could be considered medically necessary dental care, despite continued calls by beneficiary advocates and Sen. Ben Cardin (D-MD) for a broader interpretation.

Rep. Scott Peters, a Democrat pushing a watered-down Medicare drug price negotiation bill limited to Medicare Part B, on Tuesday (Oct. 14) said he is open to Medicare negotiating prices for drugs in Part D.

FDA recommends U.S. food manufacturers, chain restaurants and food service operators make gradual cuts to the amount of sodium in food products over the next two-and-a-half years with the goal of reducing the average individual sodium intake by 12%, from 3,400 milligrams per day to 3,000 milligrams per day, in a final guidance released Wednesday (Oct. 13).

FDA on Tuesday (Oct. 12) authorized the first electronic nicotine delivery system products -- R.J. Reynolds Vapor Company’s Vuse Solo products -- to be legally marketed in the United States under the agency’s premarket tobacco products application pathway, drawing protests from lawmakers and public health groups who say FDA missed an opportunity to address the youth vaping epidemic and “turned its back on the public health.”

FDA by Dec. 31 will officially withdraw three temporary policies that allowed certain businesses not regulated as drug manufacturers, including breweries and distilleries, to produce hand sanitizer during the COVID-19 pandemic, the agency announced Tuesday (Oct. 12), garnering praise from a key consumer health care organization that had raised concerns about product safety and with HHS’ decision to exempt facilities from FDA user fees.

Long-term care pharmacies are asking HHS to separate them from retail pharmacies when calculating Phase 4 provider relief distributions, calling the 10% cap on annual patient care revenue arbitrary and unfair when long-term care pharmacies’ average patient care revenues are 30% to 35% of their total revenues.