Q&A explaining ARPA-H, the opportunities, challenges and prospects for 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.

The initial proposal for an ARPA-H entity started a few years ago but has evolved in several ways. The concept of ARPA-H has also been buoyed by the success of the government’s efforts to rapidly stimulate private sector development of COVID-19 vaccines. This fits the DARPA model of taking on difficult problems, rapidly identifying possible solutions, then stimulating private development with the foreknowledge that there will be failures as well as successes.

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 important role FDA plays in providing early regulatory advice--especially in the case of cutting-edge 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 new resources will inevitably be required to facilitate FDA’s successful partnership with ARPA-H.

Q: Is the Alliance endorsing ARPA-H?

A: No. The Alliance’s purpose is to 1/ educate policymakers, media, and the public about FDA’s mission and responsibilities and 2/ advocate for increased budget authority appropriations. Accordingly, and appropriately, the Alliance is neither a proponent nor an opponent of the creation of ARPA-H. However, the Alliance wants to be sure that the FDA stakeholder community is aware of the need for additional resources for FDA if ARPA-H is created.

Q: Is it certain that Congress will create ARPA-H?

A: No. There is momentum behind the creation of ARPA-H and the House Appropriations Committee is proposing to fund the first few years. However, there are many details—large, small, and fundamental—that have not yet been resolved. If Congress creates an ARPA-H program (and it may not), it might be quite different than the brief proposal in the President’s FY 22 request.

Q.: Why is there so much uncertainty about the details of ARPA-H?

A: Unlike the other ARPA’s: 1/ there is a broad, diverse, and robust private sector in both biomedicine and medtech that has access to capital markets, 2/ the existing government investment in biomedical research (primarily but not exclusively through NIH) is already quite large and strongly supported by Congress, and 3/ there is considerably more—and quite necessary--regulatory involvement through FDA. None of these suggest ARPA-H cannot come into being, but rather that a significant number of variables are different from the prior DARPA-like efforts and must be carefully considered to be sure that the new concept and the existing efforts are well-aligned.

Q: How can my organization provide input on whether ARPA-H comes into being and what it will look like?

A: If you are interested in registering for an upcoming ARPA-H listening session being scheduled by the White House Office of Science and Technology Policy, see the list of dates here. These are scattered over the next few weeks—many of our member groups will qualify for specific days, but likely any could qualify to participate on August 4: here. In addition, at some point (yet unannounced), it is likely that the Senate HELP Committee and House Energy and Commerce Committee will decide whether and on what terms ARPA-H might come into existence.

Q: What is the exact language in the House Appropriations bill?

A: “For carrying out section 301 and title IV of the PHS Act with respect to advanced research projects for health, $3,000,000,000, to remain available through September 30, 2024: Provided, That such funds shall only be made available if legislation specifically establishing the Advanced Research Projects Agency for Health (‘‘ARPA-H’’) is enacted into law…”