Mary Woolley's Weekly Letter: Clarity

Mary Woolley

Dear Research Advocate,

Clarity is all-too elusive right now. On so many decisions, it can feel like we’re staring through soot-covered glass. Clarity — unvarnished truths and concrete solutions — is the thread that ties together every feature of our 2021 National Health Research Forum. See more on the Forum below.

A Welcome Piece of Clarity: The FDA approved the Pfizer-BioNTech COVID-19 vaccine this week for ages 16 and up. The fast-paced, but thorough approval process is testament to the speed at which research and policy can move in concert when urgency brings sufficient resources to bear. We’re grateful the FDA is applying the same level of diligence to ensuring vaccines will be safe and effective for young children.

OSTP on Clarity for Research Security: Presidential Science Advisor and Director of the OSTP Dr. Eric Lander has released an important statement on establishing Clear Rules for Research Security and Researcher Responsibility to guide federal agencies in understanding and implementing a National Security Presidential Memorandum (NSPM-33) issued last January by the previous administration.

The statement is clear in calling for protection of the nation’s security interests; it also specifies steps necessary to maintain the values that drive science, including eliminating prejudice, avoiding “pointless or performative requirements,” and maintaining an open global environment for collaboration in discovery and innovation. OSTP has set a 90-day target to develop guidance and asks stakeholders in research to email best ideas on NSPM-33 implementation.

On the Hill: This week brought a bit more clarity to the legislative process going forward: both the House and Senate have now passed an FY22 budget resolution enabling President Biden’s domestic agenda to move forward under budget reconciliation. That said, Congress is still a long way from the finish line. Unfortunately, there is little chance of a final appropriations bill passing before the 9/30/21 end of FY21. Flat funding through the fall — or even beyond — under a “continuing resolution” (CR) is likely, and negotiations will be complicated by the need to address the federal debt ceiling.

With a bumpy ride ahead, what can advocates do that can meaningfully help? The most important thing right now is to reinforce with your Senators the need for robust funding for research and public health as the draft Senate appropriations bills are put together over the next few weeks. Give them clear, brief but concrete examples of how research is important to your state. Our fact sheets — for individual states, as well as our disease-specific fact sheet series (updated in partnership with the Lasker Foundation) — can help!  

Prescription Drug User Fee Act (PDUFA): FDA has published recommendations for the reauthorization of PDUFA. A major theme relates to “biomarkers,” which are used to gauge the benefit of potential new medical interventions. Establishing viable, meaningful clinical research milestones to determine whether a medical advance will meet patient need is both critically important, and often, very challenging. Scientists, patients, and caregivers each have a role to play in clarifying what progress against a disease “looks like.” If you are a patient or caregiver, there are opportunities to help learn more about and help develop biomarkers...

Here are two: 1) On September 28, FDA is holding a public meeting to discuss its PDUFA recommendations; 2) Attend our Forum! The tough task of building patient-attuned biomarkers for rare and chronic diseases alike is one of the topics our speakers will address.

Forum Update: Excitement is building for our National Health Research Forum (#RAForum)! Three days of lively questions and conversations will help us to see more clearly across an array of pressing issues in the health-focused R&D ecosystem. We’ll explore how the sense of urgency and collaborative spirit that have defined the pandemic response can be applied to drive faster progress against a host of other pressing health challenges.

Just to highlight one session, the workshop “Learn How to Write a Compelling Opinion Piece,” will help participants to clearly articulate our positions, understanding what works and what doesn’t. This session, led by John Siniff, executive vice president at Subject Matter and former opinion editor at USA Today, is just part of the free-to-everyone event. Check out the dozens of other sessions and register now!

Upcoming Alliance Meetings: 

  • Alliance meetings will resume next week! Join us Thursday, September 2, at 1 p.m. ET. Register now to hear from Carrie D. Wolinetz, PhD, Deputy Director for Health and Life Sciences, Office of Science and Technology Policy, on OSTP’s work in the life science arena. Her clear-sighted vision, backed by significant expertise, on how to responsibly speed medical and public health progress has long been highly valued in the federal policy arena, and we are thrilled to host her for this meeting.

  • On Thursday, September 9, at 11 a.m. ET, we will hear from Rima F. Khabbaz, MD, Director of the National Center for Emerging and Zoonotic Infectious Diseases at CDC. She is playing a key role in the COVID-19 response, the fight against antimicrobial resistance (another forum topic!), and a host of other important public health issues.

Stay well, stay safe, and stay connected.

Sincerely,

Mary Woolley

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Without research, there is no hope.
The Honorable Paul G. Rogers