Q&A on what happens if a CR isn’t passed; FDA’s role is ARPA-H is created
FDA if a CR is not adopted; FDA and ARPA-H
Q: What happens on October 1 if Congress has not passed a CR?
A: Technically, if the CR has not become law by 12:01 a.m. on October 1, then parts of the government (including a substantial part of FDA) will cease to operate. This would start with shut-down activities on October 1 and closed offices thereafter. If the CR is not ready by the deadline, there are two possibilities: 1/ Congress can pass a short-term CR for 3 or 4 days to give itself more time, or 2/ the President can make a declaration that Congress is close enough to an agreement and keep the government running for a few days. With October 1 being a Friday, the main impact of a shut-down would not occur until the following Monday, October 4.
In sum, a shutdown can never be ruled out, but there are ways that Congress and the President can address any short-term gap without disrupting government. As October 1 comes closer, we will continue to inform Friday Update readers of the likely outcomes if the CR reaches the brink of October 1 without passage.
Q: What is the reason for the sudden focus on creating ARPA-H?
A: Admiration for the accomplishments of the Defense Advance Research Project Agency (DARPA) is longstanding and widespread in Washington. More than a decade ago, Congress created I-ARPA (history here) to promote innovations in national intelligence, and subsequently, ARPA-E (history here) to promote innovation in energy solutions. Earlier this year, President Biden promoted the idea of an ARPA-C (White House announcement here) for climate innovations, as well as ARPA-H for health innovation.
Q: What about the FDA’s role in ARPA-H?
A: Proponents of the ARPA-H proposal have discussed the importance of strengthening key linkages between clinical research and patient-centered medical care to speed new treatments to the bedside. If the ARPA-H proposal advances, we believe policymakers should consider the vital role FDA plays in providing early regulatory advice--especially in the case of innovative novel medical products—as well as its role in the rapid and thorough review of medical products to protect the public health. If ARPA-H is created, then added resources will inevitably be required to facilitate FDA’s successful partnership with ARPA-H.
To a degree, this is reflected in the text of the House Energy and Commerce reconciliation package. Specifically, it provides that ARPA-H shall engage in:
“ (vi) translating scientific discoveries into technological innovations, including through—
collaboration with the Food and Drug Administration on the development of medical products to facilitate transformation of breakthroughs in biomedicine into tangible solutions for patients; and
ensuring that medical product development programs gather nonclinical and clinical data necessary for approval as efficiently as practicable;”
Editorial Note: The Analysis and Commentary section is written by Steven Grossman, Executive Director of the Alliance for a Stronger FDA.