Dear Research Advocate:
I warn you that today’s letter is long. There is a lot going on; suddenly, lots of people in Congress are staking out leadership roles as champions for research! On Tuesday, the first draft of the much anticipated 21st Century Cures legislation was released. Chairman Fred Upton (R-MI-06) and Congresswoman Diana DeGette (D-CO-01), who will jointly receive Research!America’s 2015 Edwin C. Whitehead Award for Medical Research Advocacy at our Advocacy Awards dinner on Wednesday, March 11 (click here to join us for the event), have been partnering on this effort since last spring. Congresswoman DeGette has not endorsed the current draft, but she has made it clear that she continues to be committed to the process. We are, too. Over the coming weeks, we will be meeting with the 21st Century Cures team and participating in a variety of discussions on the intricacies of the bill.
Among our priorities will be to ensure that basic discovery is not neglected (a house built on sand…), and to make sure that, for the U.S. Food and Drug Administration (FDA) and other agencies – already struggling to fulfill their current responsibilities – if given new “to do” lists, must also be given new resources. We will continue to push for final bipartisan language that effectively boosts the return on medical progress by accelerating discovery, development and delivery. See our statement on the 21st Century Cures release here. And click here to see the Committee’s documents. They have invited suggestions on the draft, and ask that you send your comments to firstname.lastname@example.org.
Just today, Senate Health, Education, Labor and Pensions (HELP) Committee Chairman Lamar Alexander (R-TN) and long-time Committee member and medical innovation advocate Richard Burr (R-NC) launched an effort similar in intent to 21st Century Cures with the release of a white paper entitled “Innovation for Healthier Americans.” Their effort will revolve around the following premises (Note that the term “premise” is important since the plan is to engage in a fact finding process that could challenge the veracity or priority of these initial framing concepts):
- It costs too much to bring medical products through the pipeline to patients.
- As science and technology advance, the discovery and development process takes too long for medical products to make their way to patients.
- FDA’s responsibilities have grown to include many activities unrelated to the core function of regulating medical products to advance the public health.
- The disparity in scientific knowledge at FDA and the fast pace of biomedical innovation are slowing, and in some cases, stifling, innovation in American medicine.
- A working FDA is essential to continuing biomedical innovation in the United States and maintaining America’s global leadership in medical innovation.
It’s a remarkable time for research and innovation in Washington. Beyond the initiatives I just mentioned, there is the President’s ongoing push for research “moonshots,” including the Alzheimer’s and BRAIN projects, previously launched, and now new efforts to address antimicrobial resistance and accelerate precision medicine. Watch for budget details on these in the next day or two. And four – count them, four – bills have been introduced or are in the works to increase and then stabilize the National Institutes of Health (NIH) funding, and in the case of two of the bills, supplement funding for other research agencies. Senator Elizabeth Warren (D-MA) plans to introduce the Medical Innovation Act, which would provide supplemental funding for NIH and FDA. We hope this bill will be modified along the way to change the source of new funding for NIH. Representative Rosa DeLauro (D-CT-03) re-introduced the Harkin/DeLauro Accelerating Biomedical Research Act, along with cosponsors Brian Higgins (D-NY-26) and Peter King (R-NY-02). It would allow an exemption from the statutory budget caps through 2021 for the purpose of providing supplemental funding to NIH. Senator Richard Durbin (D-IL) re-introduced his American Cures Act this week. Senator Durbin’s bill would fund NIH, the Centers for Disease Control and Prevention (CDC), the Department of Defense Health Programs and Veterans Medical & Prosthetics Research program at 5 percent above inflation for the remainder of sequestration. And Representative Kathy Castor (D-FL-14) plans to reintroduce legislation to increase NIH funding and make it mandatory rather than discretionary.
That Congress and the White House are focusing special attention on accelerating medical progress is truly heartening. Let’s make this our moment and see to it that the attention engenders tangible, sustained, medical progress. That means streamlining regulations and it means more funding. It means overcoming inertia and politics and budgets that ignore the long-game. Join me in sending a message to Congress here to advance medical research and innovation in fiscal year 2016 appropriations as the process formally begins. Join me in weighing in on the 21st Century Cures draft and the Alexander/Burr initiative. When it comes to faster or slower medical progress, silence truly is deadly.
Feb. 6 is the deadline for application to “Connecting the Dots: Effectively Communicating Science to Non-Scientists,” a two-day program that we are conducting with the George Washington University School of Media and Public Affairs. The program will equip researchers and academics at the post-graduate level and above with the information and tools needed to effectively share their work and emphasize the human health and economic benefits of research. Please spread the word! Learn more and apply here.