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Alliance Statement on Confirmation of HHS Secretary Becerra

March 19, 2021

Yesterday, the Alliance for a Stronger FDA congratulated Secretary Becerra on his confirmation and urged him to swiftly nominate and seek prompt confirmation of a permanent Commissioner to lead the FDA. … READ MORE …

DMAP: Focusing on a Fundamental Challenge

March 13, 2021

The FDA’s new Data Modernization Action Plan (DMAP) (here) is the focal point for one of FDA’s greatest challenges: its myriad databases don’t communicate with each other, even within the same Center. Countless inefficiencies result. … READ MORE …

Advocacy at a Glance

March 13, 2021

Top Line: COVID relief legislation becomes law, providing $500 million in no-year money to support FDA’s work on COVID and related items. HHS Secretary-Designate Xavier Becerra is likely to be confirmed next week. Senator Baldwin received positive back-home press. GAO’s report highlights the need for FDA to ramp up inspections once the pandemic threat has receded. FDA releases its Data Modernization Action Plan (DMAP), a critical foundation for FDA’s growing challenges and opportunities. This week’s Analysis and Commentary explores DMAP.

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Critical Supply Chains and the FDA

March 6, 2021

FDA has a portfolio of responsibilities that relate to our nation’s supply chain for food and medical products, as well as OTC, cosmetics, and dietary supplements. Some of that work focuses on quality and security, other parts on intentional and unintentional adulteration. Addressing drug shortages is yet another way FDA is involved because the supply chain is often a critical part of the problem. … READ MORE …

Advocacy at a Glance

March 6, 2021

Top-Line: The Senate has taken up the COVID relief reconciliation bill and is expected to be done before March 8, assuming the Senate will work this weekend if necessary. At stake is $500 million in no-year money to support FDA’s COVID-19 related work. These monies will not cover the costs of non-COVID programs at FDA that continue to grow. HHS Secretary-designate Becerra’s nomination advanced out of committee and a floor vote is expected either the week of March 8 or 15. The President announced a new government-wide initiative to strengthen critical supply chains, including a number of areas under FDA’s jurisdictions. Details and impact on FDA are discussed in this week’s Analysis and Commentary. … READ MORE …

Questions (and Answers) About Current Political Issues

February 28, 2021

Q: If the reconciliation bill becomes law, are FDA’s funding needs taken care of?
 
A: Not at all. Having the agency’s COVID-related resource needs covered by reconciliation — which is extremely important — does not lessen the budget and personnel needed to fulfill the agency’s mission and carry out its responsibilities. COVID apart, FDA’s mandate in FY 22 will be larger than it was in FY 20 or FY 21.  
 
Why this is so ,,, was covered at length in last week’s Analysis and Commentary (here). To recap the major points:

  • No federal agency has a broader range of responsibilities than the FDA;
  • No federal agency’s mission and responsibilities are more affected by changes in science, technology, innovation, and social trends than the FDA.

For example, FDA has approved 19 cell and gene therapies (here), but now must manage more than 900 INDs in this segment. A large portion of those INDs involve cutting-edge science. For another example, FDA’s  New Era of Smarter Food Safety (here) is premised on the prediction that the food system will see more changes “over the next 10 years than we have in decades.”
 
Q: At Secretary-Designate Becerra’s confirmation hearings, it was pointed out that he does not have a healthcare or science background. Should this concern FDA or the other Public Health Service agencies?
 
A: Since the creation of the Department of Health, Education and Welfare in 1953 (and its successor the Department of Health and Human Services in 1980), the Department has been led by individuals with medical, public health, or scientific training only three times. Dr. Otis Bowen (physician, also a former governor) was Secretary from 1985 to 1989 and was succeeded by Dr. Louis Sullivan (physician, also a senior leader of an academic institution) from 1989 to 1993. Dr. Tom Price (physician, also a former Member of Congress) served briefly in 2017. Perhaps not surprisingly, almost all other Secretaries of the Department had similar backgrounds but without medical degrees: governors, senior leaders of academic institutions, members of Congress, and veterans of the Executive Branch.
 
That is to say that FDA (and the other Public Health Service agencies) can expect to have the same range of experiences — good and bad, smooth and frustrating — with the new Secretary as they have had with prior Secretaries. Secretaries turn to their agency heads for advice and leadership. There are also individuals with medical and life sciences backgrounds in the Secretary’s staff offices.
 
To be clear: this is not commentary on the nomination of Secretary-Designate or a prediction of likely relationships. It is merely an answer to the question: Is there an issue for FDA because the Secretary-Designate lacks medical or scientific training. Historically, the answer is “No.”

Editorial Note: The Analysis and Commentary section is written by Steven Grossman, Executive Director of the Alliance for a Stronger FDA.

Advocacy at a Glance

February 28, 2021

Top-Line: The reconciliation legislation, with substantial money to support FDA’s COVID activities, is advancing, but slowly. HHS Secretary-Designate Becerra faced confirmation hearings this week, but there were only a couple of questions involving FDA, none of them major. A panel and a great infographic on COVID-19 therapies is described. CDRH reached milestones in 2020 in its support of innovation in medical devices. … READ MORE …

“FDA Exceptionalism,” Redux (Again)

February 19, 2021

In a town full of special interests, it takes a certain moxie to claim that your interest represents needs that are uniquely important. I am going to do it, anyway. I believe in FDA exceptionalism and you should too. … READ MORE …