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“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 …

Advocacy at a Glance

February 19, 2021

Top-Line: Senator Tammy Baldwin is the new Chairwoman of the Senate Ag/FDA appropriations subcommittee. Reconciliation is advancing and includes $500 million to support FDA’s COVID activities. Confirmation hearings will be held next week for Xavier Becerra, the President’s nominee to run HHS. Here in this week’s Advocacy at a Glance we also look at the breadth of FDA responsibilities covered in this week’s media. This week’s Analysis and Commentary is devoted to “FDA exceptionalism” based on the continuing growth of FDA’s mission. Supportive words are noted from House E&C Health Subcommittee Chairwoman Anna Eshoo.

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FDA-related Provision of House Reconciliation Bill

February 13, 2021

Q: What is contained in the FDA-related provision of the House Reconciliation bill?

A: There is a provision that would make $500 million in no-year funds available to support COVID-19 activities at FDA. The specific text follows, which is re-formatted for clarity:

SEC. 3004. FUNDING FOR COVID–19 VACCINE, THERAPEUTIC, AND DEVICE ACTIVITIES AT THE FOOD AND DRUG ADMINISTRATION. In addition to amounts otherwise available, there is appropriated to the Secretary for fiscal year 2021, out of any money in the Treasury not otherwise appropriated, $500,000,000, to remain available until expended, to be used for
  1. the evaluation of the continued performance, safety, and effectiveness, including with respect to emerging COVID–19 variants, of vaccines, therapeutics, and diagnostics approved, cleared, licensed, or authorized for use for the treatment, prevention, or diagnosis of COVID–19;
  2. facilitation of advanced continuous manufacturing activities related to production of vaccines and related materials;
  3. facilitation and conduct of inspections related to the manufacturing of vaccines, therapeutics, and devices delayed or cancelled for reasons related to COVID–19;
  4. review of devices authorized for use for the treatment, prevention, or diagnosis of COVID–19; and
  5. oversight of the supply chain and mitigation of shortages of vaccines, therapeutics, and devices approved, cleared, licensed, or authorized for use for the treatment, prevention, or diagnosis of COVID–19 by the Food and Drug Administration.

Q: What did the Alliance say about the FDA funding provision in the House reconciliation bill?

A: The Alliance’s statement on the FDA funding provisions in the House reconciliation bill:

The FDA stakeholder community appreciates and supports the House Energy and Commerce Committee’s decision to include $500 million in no-year money to support COVID-19 activities at FDA. This assures that FDA has the funds it needs as its workload grows and shifts in response to the pandemic. Neither the pandemic nor FDA responsibilities in this area can be neatly segmented by fiscal year, so the flexibility provided by these funds is enormously valuable.
Apart from its COVID-19 work, FDA’s mission and responsibilities have grown considerably in the last year and additional base funding will be needed in FY 22. We look forward to working with the Administration and the Appropriations committees to fully support the agency’s funding needs in areas such as food safety, cell and gene therapy, digital health, and advanced manufacturing.

Q: How was the $500 million for FDA determined?

A: During the reconciliation mark-up in the House Energy and Commerce Committee on February 11, Representative Eshoo, Chair of the Health Subcommittee, said that the $500 million was what FDA told her was needed to support its COVID-19 activities and assure the necessary flexibility to use the money when and where it would be needed to combat the pandemic.

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

Advocacy at a Glance

February 13, 2021

Top-Line: Under the House reconciliation bill, FDA would gain $500 million in no-year money to support its COVID-19 activities. The Alliance issued a statement of support for these funds. … READ MORE …

Alliance’s “Ask” for FY 22: Member Input Is Requested

February 5, 2021

As described in last week’s Analysis and Commentary, the Alliance usually develops its “ask” after the release of the President’s Budget. That doesn’t work in the first year of a new Administration, when the budget request is likely to be delayed for both substantive and political reasons. As a result, the Alliance is likely to be talking with Congress about FDA’s needs before President Biden releases either a “skinny” or full budget request. … READ MORE …

Advocacy at a Glance

February 5, 2021

Top-Line: The Senate has announced committee assignments. Senator Merkley will chair the Ag/FDA Appropriations Subcommittee and Senator Hoeven will be the Ranking Member. The FY 22 funding cycle has started at the staff level, but both House and Senate have other business to address before the process can get underway. The Alliance is soliciting input from its members about what they see as the FDA’s priority funding needs for FY 22. GAO has made a set of recommendations concerning FDA inspection practices.

Senate Power-Sharing Agreement Finalized; Democrats Become Majority Party. Senate assignments have now been finalized. Senator Merkley will chair the Ag/FDA Appropriations Subcommittee and Senator Hoeven will be the Ranking Member. Our congratulations to both of them. We look forward to working with them to make the FDA stronger and better resourced to assure that the agency can fulfill its mission and responsibilities.

FY 22 Funding Cycle: Multiple Distractions Before Congress Digs In. While staff have started work on FY 22 funding issues and the new Administration is putting its FY 22 budget request together, there will still be plenty to occupy Congress, especially the Senate. The House and Senate have just passed their FY 21 Budget Resolution and multiple committees are expected to quickly start to address the reconciliation instructions they have been given. The Senate has the impeachment trial next week and is also working through confirmation hearings/votes for President Biden’s nominees.

Alliance Begins Process of Formulating FY 22 “Ask;” Solicits Input from Its Members. This is going to be a difficult year for FDA to receive a significant increase in its budget. However, it is also a time (new administration, mid-pandemic, extraordinary pressures on the agency, accelerating growth in new science) in which it is essential that we lay out a bold agenda of FDA’s needs and opportunities for FY 22 and the years beyond that.

This week’s Analysis and Commentary looks at some possible themes and initiatives that the Alliance may want to consider advancing for FY 22. We hope this will stimulate Alliance members to tell us what they consider the most important FDA funding priorities — whether discussed below or derived from your own experiences and thinking. Alliance members are encouraged to send their thoughts, preferably by February 22, to Steven Grossman at the Alliance.
 
GAO Recommends Changes in FDA Inspection Practices. As reported by Regulatory Focus, GAO made two recommendations to FDA related to inspections during and beyond the pandemic. First, GAO calls on FDA to fully assess its alternative inspection tools and “consider whether these tools or others could provide the information needed to supplement regular inspection activities or help meet its drug oversight objectives when inspections are not possible in the future.” Second, GAO frets that a looming backlog of inspections could jeopardize the agency’s strategic goal of shifting more of its inspections to a risk-based model and instructs the agency to assess its inspection plans for the coming years.

Biden’s Budget Request for FY 22 and Related Issues

January 29, 2021

Presidents routinely send their budget requests to Congress in early February — except when it is a new administration.  In those instances, a “skinny budget” with top-line priorities usually comes in late February or early March, with the detailed budget request coming later. … READ MORE …

Advocacy at a Glance

January 29, 2021

Top-Line: Representatives Bishop and Fortenberry have been formally named as Chair and Ranking Member, respectively, on the House Appropriations Subcommittee on Ag/FDA. We expect Senators Merkley and Hoeven will be named Chair and Ranking Member on the Senate side, but assignments have not been formally made. This year’s appropriations process will be different than prior years, a topic that is discussed here in Advocacy at a Glance and in this week’s Analysis and Commentary. … READ MORE …