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Analysis and Commentary

June 14, 2021

Acting FDA Commissioner Woodcock’s testimony before the Senate Ag/FDA Appropriations Subcommittee was well-received and reflected a lot of goodwill on the subcommittee toward FDA.



What did Dr. Woodcock Tell the Subcommittee?

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Advocacy at a Glance

June 14, 2021

Top-Line: Acting Commissioner Woodcock testifies on FY 22 Budget. The Alliance applauds the President’s FY 22 Budget Request for a $343 million increase in Budget Authority (BA) Funding. A webinar with FDA’s food and animal health leadership will be held on June 16. A webinar with Associate Commissioner for Regulatory Affairs (ACRA) Judy McMeekin will be held on July 14 and a webinar with CDRH Director Jeff Shuren will be held on July 22. The annual report from FDA’s Office of Surveillance and Epidemiology shows 2.2 million Adverse Events Reports sent to FDA in 2020.
 

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President’s Budget Request Confirmed for FY 22

June 4, 2021

After further review, we can confirm that the President’s request is for $343 million in additional budget authority (BA) (taxpayer) funding. The Alliance is committed to advocating for this number and will amplify this message to Congressional offices over the next ten days. … READ MORE …

Advocacy at a Glance

June 4, 2021

Top-Line: The Alliance applauds the President’s proposed increase of $343 million in FDA’s BA budget. The Senate Agriculture-FDA Appropriations Subcommittee set its FDA budget hearing for June 10. Macro budget concerns will impact the ultimate level of funding provided to FDA. The Alliance’s webinar with FDA’s Food and Animal Health Leadership set for June 8 has been rescheduled to June 16. Other upcoming webinars include CDRH Director Dr. Jeff Shuren on July 22. Dr. Eric Lander has been confirmed by the Senate as the President’s Chief Science Advisor and Director of the White House Office of Science and Technology Policy.

Alliance Applauds President’s Budget Request for $343 million Increase in BA Funding. The Alliance is pleased with the President’s Budget Request and will urge Congress to adopt its increase of $343 million in Budget Authority (BA) appropriations for FDA in FY 22. Consistent with this, the Alliance submitted testimony for the record on June 1 (see here). The basics are:

  • $185 million in additional investments in FDA’s Critical Public Health Infrastructure. This includes monies for data modernization, as well as for improvement and expansion of FDA buildings and facilities, notably laboratory capacity.
  • $97 million in additional investments in Core FDA Safety Programs. This includes monies to enhance core food and medical product safety programs, such as human and animal food safety, maternal and infant nutrition, medical product supply chain surveillance, and animal drug safety.
  • $61 million in additional investments in Public Health Issues Confronting the U.S. This includes monies for increased inspections, promotion of health equity, and addressing the opioid crisis.

More details are examined in this week’s Analysis and Commentary and we have provided the Alliance’s chart showing proposed increases by center and function, with FDA’s description of program increases. For those who want the original without abridgment, the 400-page Congressional Justification (CJ) document is here.

First Congressional Hearing on FY 22 FDA Budget Set for June 10. Acting Commissioner Janet Woodcock will testify on June 10 at 10:00 a.m. ET before the Senate Appropriations Committee’s Subcommittee on Agriculture, Rural Development, FDA, and Related Agencies. She will review the President’s FY 22 budget request with the subcommittee. Details and a video feed for the hearing can be found here.

Macro Budget Concerns Affect FDA’s Ability to Receive a Large Increase in FY 22. For the first time in a decade, there are no defense and non-defense spending ceilings set out in law. That means no threat of sequestration, but also that there is no starting point for negotiations on total FY 22 spending. The President’s ambitious budget may not fit under whatever spending ceilings Congress ultimately agrees to. If that became the case, then many or most federal agencies would likely receive less than the President requested. However, House Budget Committee Chairman John Yarmuth has indicated that his committee will advance spending levels consistent with the President’s request. This is good news, but just the beginning of what could be a protracted debate about FY 22 spending levels. This is described by Roll Call here.

Upcoming Alliance Webinars. We continue to invite FDA leadership to address the Alliance membership and media. Note that the date and time for next week’s webinar with FDA’s food safety and animal health leadership team has been rescheduled so that it will be after Dr. Woodcock testifies before Congress.

  • FDA’s Food and Animal Health Leadership (will now be on June 16 from 11:30 a.m. to 12:30 p.m. ET). For Alliance members and media: Please join us for a virtual presentation on June 16 from 11:30 a.m. to 12:30 p.m. ET by Deputy Commissioner Frank Yiannas, CFSAN Director Susan Mayne, and CVM Director Steven Solomon. To sign up, please register here.
  • CDRH Director Jeff Shuren (July 22). For Alliance members and media: Please join us for a virtual presentation by CDRH Director Dr. Jeff Shuren on July 22 from 10:00 to 11:00 a.m. ET. To sign up, please register here.

Dr. Eric Lander Confirmed as President’s Chief Science Advisor. Dr. Eric Lander has been confirmed by the Senate as the President’s Chief Science Advisor and Director of the White House Office of Science and Technology Policy. As part of President Biden’s commitment to science and innovation, he has designated the post to be part of his cabinet. We have tracked his nomination and confirmation as relevant to FDA because Dr. Lander would be the first life scientist to hold this position.

President’s Budget Request: Preliminary Analysis

May 30, 2021

The President’s Budget Request was released on Friday afternoon and we have begun to unpack the content. Expect a more detailed analysis from the Alliance early next week. … READ MORE …

President to Release FY 22 Budget Request Today

May 28, 2021

The President is going to release his Fiscal Year (FY) 2022 budget request today (Friday, May 28, 2021). … READ MORE …

Advocacy at a Glance

May 28, 2021

Top-Line: The President’s FY 22 Budget is being released on May 28. An analysis of the FDA request will be provided to Alliance members following our internal review. Thus far the Alliance is recommending an increase of at least $200 million over FY 21, and will make further recommendations based on the submitted budget. Two successful Hill Days with Senate staff were completed this week. Two upcoming webinars — FDA’s Food and Animal Health Leadership (June 8) and CDRH Director Jeff Shuren (July 22). … READ MORE …

Messaging for Upcoming Senate Hill Days

May 21, 2021

The FDA’s “broad, complex, and growing responsibilities” is the core message of all Alliance Hill meetings. However, the reality of this statement can be hard to convey in a short meeting. … READ MORE …