CR and User Fees Next Week; Alliance participating in Reagan-Udall Review; ARPA-H Director Announced

Top-Line

  • Senate Sets Procedural Vote on FY 23 Continuing Resolution (CR) Next Week.

  • User Fee Extension Expected as Part of CR.

  • Alliance to Participate in Reagan-Udall Foundation Review of Human Food Programs.

  • Dr. Renee Wegrzyn Named Inaugural Director of ARPA-H.

  • FDA Boosted by Executive Order on Biotechnology and Biomanufacturing.

  • Upcoming Alliance Webinars:

    • September 27 at 11:30 a.m. “FDA and One Health.” with Dr. Steven Solomon, Director of the Center for Veterinary Medicine, and Dr. Namandjé N. Bumpus, FDA’s new Chief Scientist.

    • October 20 at 1:30 p.m. “Digital Health and Cyber Security" with Dr. Suzanne Schwartz, Directors of CDRH’s Office of Strategic Partnerships & Technology Innovation (OST).

Senate Sets Procedural Vote on FY 23 Continuing Resolution (CR) Next Week. Senate Majority Leader Schumer has filed a cloture motion setting a vote for next Tuesday or Wednesday that would allow the Senate to initiate action on the CR. However, the text of the CR has not yet been released and details on Senator Manchin’s proposal to set two-year targets for permitting provisions under the National Environmental Policy Act (NEPA) have not been revealed. Given that Senator Bernie Sanders has said he will oppose the Manchin effort, the passage of a CR will need eleven Republicans in support. If the Senate does not act, it is possible that the House will initiate a CR without the energy provisions.

As reported in previous Friday Updates, FDA’s resources are capped under a CR, limited to the level of funds available in the prior fiscal year. There are also restrictions on the start of new programs, though modest efforts in prior fiscal years have, on occasion, served as predicates for new activities under CRs.

User Fee Extension Expected to be Part of the CR. It has also been announced that the leadership of the Senate HELP Committee and the House Energy and Commerce Committee have reached an agreement to reauthorize FDA user fees for five years and to add this extension to the CR. Some policy riders will also be included, but as this report is being prepared those riders have not been identified nor has specific bill language been released.

Other policy riders including how FDA regulates diagnostics, dietary supplements, and cosmetics continue to be negotiated and could be included as part of the omnibus measure that is possible in December. As we suggested last week, some provisions could slip into the 118th Congress.

Alliance to Participate in Reagan-Udall Foundation Review of Human Food Programs. The Reagan-Udall Foundation, as part of its human food review requested by Commissioner Califf, will be holding two days of information gathering next week—on September 29 and 30. Our earlier story on the Independent Expert Panel is here.

The Alliance has been asked to present a short tutorial on how FDA and its human foods programs are funded. Alliance Executive Director, Steven Grossman, will be chairing the session on Resources, and also present the Alliance’s comments.

Dr. Renee Wegrzyn Named Inaugural Director of ARPA-H. The White House on Sept. 12 announced that President Joe Biden intends to appoint Renee Wegrzyn, PhD, as the inaugural director of the Advanced Research Projects Agency for Health (ARPA-H). She is currently engaged in the private sector working on applied synthetic biology to outpace infectious diseases – including COVID-19 – through biomanufacturing, vaccine innovation, and biosurveillance of pathogens at scale.

Among prior roles, she was a program director at the Defense Advanced Research Projects Agency (DARPA) and worked with the federal Intelligence Advanced Research Projects Activity (IARPA). She holds a Ph.D. in applied biology.

The Alliance has been interested in the creation of ARPA-H—neither for nor against it (outside our mission) but concerned that the new agency fully includes FDA and enter into reimbursable agreements for the FDA effort.

FDA Boosted by Executive Order on Biotechnology and Biomanufacturing. On September 12, 2022, President Biden signed an order entitled: “Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy.” This is a whole-government effort with specific focus on projects at the Department of Defense and the Department of Health and Human Services. Details are covered in last week’s Analysis and Commentary (here).

Upcoming Alliance Webinars-

September 27 at 11:30 a.m - “FDA and One Health.” Our guests will include Dr. Steven Solomon, Director of the Center for Veterinary Medicine, and Dr. Namandjé N. Bumpus, FDA’s new Chief Scientist. REGISTER HERE.

“One Health” is an approach to solving health problems by recognizing the interconnection of people, animals, plants, and the environment. FDA is one of many federal agencies that support this approach and encourages its use. The webinar will explain the concept in more detail and feature presentations on how FDA’s work utilizes One Health.

October 20 at 1:30 p.m. - “Digital Health and Cyber Security" with Dr. Suzanne Schwartz, Directors of CDRH’s Office of Strategic Partnerships & Technology Innovation (OST). REGISTER HERE.

The Center for Devices and Radiological Health's Office of Strategic Partnerships and Technological Innovation is a key leader for all scientific collaborative and emerging technology. The Office is an innovative leader in digital collaborates with patient organizations, healthcare professional organizations, industry, scientific and other external organizations to address unmet public health needs with emerging technology. On top of their partnership goals, the Office also manages CDRH's medical device cybersecurity, software, and digital health standards. We look forward to talking with Dr. Schwartz about her experience and needs in this innovative area.

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FDA Boosted by President Biden’s Executive Order on Biotechnology and Biomanufacturing