COVID-19 Evidence Accelerator: What We've Learned, Where We're Headed

In the midst of a global pandemic, the Reagan-Udall Foundation for the FDA, along with Friends of Cancer Research, created an unprecedented regulatory science collaborative to share real-world data and to generate innovative responses on how to deal with COVID-19. 

On October 20, 2022, we highlighted the accomplishments and shared learnings from more than 200 meetings, and 275 expert presentations, including how best to leverage real-world data and improve data interoperability to address current and future health challenges.

Henney, Silvis Tapped as Lead Evaluators

(August 17, 2022) The Reagan-Udall Foundation announced today that former Commissioner of Food and Drugs Jane E. Henney, MD, and former FDA Chief of Staff Lauren Silvis, JD, will lead the operational evaluation of the Food and Drug Administration’s human foods and tobacco work. Henney will lead the evaluation team focused on human foods while Silvis will lead the team focused on tobacco. The project was announced by Commissioner Robert Califf late last month. 

Announcements

Operational Evaluation of FDA's Human Foods & Tobacco Programs

As announced on July 19, 2022, the Reagan-Udall Foundation facilitated, via two Independent Expert Panels, operational evaluations of FDA’s human foods and tobacco programs. Each evaluation yielded a report with operational recommendations to the FDA: one for human foods and the other for tobacco. Each evaluation, and therefore report delivery, was on its own 60-business-day timeline. Both reports were delivered to the FDA Commissioner and made available to the public.

Inside FDA’s big food reboot - Food Fix

When FDA announced last month it had commissioned an outside evaluation of its foods program (as well as tobacco), it was seen by many as a formal, if somewhat tepid, admission that something had gone very wrong at the agency.

“Fundamental questions about the structure, function, funding and leadership need to be addressed,” FDA Commissioner Robert Califf said at the time. Read more

Coverage

Big shakeups under way in much-criticized U.S. health agencies - JD Supra

While most regular folks wouldn’t give a hill of beans about the organization of bureaucracies in Washington, D.C., frustrated taxpayers should be taking note of seismic rumblings about restructurings that are shaking some of the biggest, most powerful, and influential federal health agencies. Biden Administration officials, in one of their notable moves, have announced that responses to pandemics and other public health crises will be led now by a separate, independent division within the sprawling Health and Human Services agency.

Coverage
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