P4C—Mixing Policy and Politics: Opportunities and Challenges for Our President-elect
With Election Day 2016 in our rearview window, a diverse set of leaders took the stage to discuss how the changing landscape in Washington, DC, will affect biomedical innovation. “Mixing Policy and Politics: Opportunities and Challenges for Our President-elect” was moderated by Politico journalist Dan Diamond. Although the Affordable Care Act was a major focus of the election, biomedical innovation—the development of new drugs, biologicals and devices—was not a focus of either the Trump or Clinton campaigns, apart from the prescription drug pricing issue. As a result, the panel discussion focused on recommendations for President-elect Trump to ensure that the sector remains strong over the next four years. FasterCures’ has also been focusing on recommendations for the next administration. Our Rx for Innovation report, released at Partnering for Cures, synthesized interviews with more than 150 thought leaders from across the innovation system and identified 26 recommendations for President-elect Trump and his team that will help accelerate the development of new therapies and cures.
Keith Yamamoto, from University of California, San Francisco (UCSF), opened the panel with a brief history lesson, recounting Vannevar Bush’s famous “Science the Endless Frontier” letter to President Roosevelt in 1945, in which he detailed the central role of the federal government in supporting basic science research. Basic science is still needed to improve our understanding of disease mechanisms, which will ultimately lead to less expensive drug development, accelerated regulatory approval, and most importantly more treatments for patients.
From left: Tanisha Carino, vice president of U.S. Public Policy, GSK; Dan Diamond, author of Politco Pulse; Dora Hughes, senior policy advisor at Sidley Austin LLP
New administrations, with more than 4,000 new appointees and new perspectives and polices, can’t help but make changes big and small. The complexity and interconnectedness of the innovation system led to Kay Holcombe, from the Biotechnology Innovation Organization (BIO), and GSK’s Tanisha Carino both calling for careful consideration and engagement with all stakeholders before the new administration acts. Holcombe reflected that new administrations can be “eager to make a difference by making a change, but they can also make a difference by supporting what is already working well.” In addition to support for research funding at the National Institutes of Health (NIH), another effort already working well is the Food and Drug Administration (FDA) user fee agreements that were negotiated with—and strongly supported by—the biopharmaceutical and medical device industries throughout 2016. These fee agreements will need to be enacted into law in 2017 with a new Congress and new president. It was noted that the medical product industry—and the financial markets that provide the capital required to develop new products—look for stability in the rules and regulations governing the development and marketing of FDA-regulated products. A panelist cautioned that the administration should be clear and consistent when communicating any policy changes, and should guard against the perception that FDA’s regulations could be changing “randomly,” which would cause harm to the system.
Another tropic that generated considerable discussion was the prospects of the 21st Century Cures legislation (21CC), which would make important reforms to the biomedical innovation system, support health information technology interoperability, provide FDA with new tools to hire and retain talent and provide a surge of funding for NIH (and potentially FDA as well). This bipartisan legislative package was overwhelmingly passed in the House of Representatives as H.R. 6 in July 2015, and a similar set of bills moved through the Senate Health, Education, Labor, and Pensions committee in 2016. With Congress returning to Washington on Monday, November 14, for a “lame duck” session, congressional leaders have indicated that funding the government is the first priority and passing 21st Century Cures is the second. There are outstanding questions about the source of funds to support the surge in NIH funding, and, despite the bipartisan support for the legislation, the change in the political landscape may impact the prospects for passage of the bill given that the Congress will be in session for only 3-4 weeks. Dora Hughes from Sidley Austin LLP said, “I’m hopeful that 21st Century Cures will get through…many of the bill’s policies are also priorities for Democrats” including funding and formal authorization of the Cancer Moonshot and the Precision Medicine Initiative. So there should be common ground to pass the bill to send to President Obama before the 114th congressional session ends. (Bills introduced in one two-year congressional session cannot carry over into the next. The committee would have to start from scratch when the 115th congressional session starts in January.) Andrew von Eschenbach from Samaritan Health Initiatives, and a former FDA commissioner, said that all the outstanding policy issues should have been resolved, and the only barrier to the bill’s passage would be “political.” Given the lifesaving nature of biomedical innovation, “if it doesn’t pass because of political issues, there will be consequences for the Members of Congress responsible.” Holcombe boiled down 21st Century Cures to this: “Cures says, let’s put our heads together to slim down drug development and accelerate” biomedical research.
Milken Institute Senior Fellow Andrew von Eschenbach
There was also a call to recognize the global nature of the biomedical innovation system—both in basic science and in the biopharmaceutical industry. Panelists expressed hope that the new administration would keep that in mind as it formulates broader trade and immigration policies. In addition, Yamamoto and Holcombe commented that, given the essential need for cross-sector collaboration to accelerate drug development, President-elect Trump and his White House will have a singular ability to bring together stakeholders from across the country and focus them on finding solutions.
As Diamond brought the panel to conclusion, he asked the panelists to name the one person who they will watch in the weeks before Inauguration Day. Diamond will watch House Speaker Paul Ryan. Von Eschenbach will watch the new White House Chief of Staff Reince Priebus, and Hughes will look for the nominees for FDA Commissioner and NIH Director. Holcombe will watch Newt Gingrich, Trump advisor and strong biomedical research supporter. The biomedical innovation community will have much to watch over the next weeks and months. The good news is that medical research and development of new has proven to be an issue with long-running, bipartisan support. We all need to work together to develop new disease treatments.