When a new administration enters the White House, the ACR has a tradition of seeking meetings with the newly confirmed heads of the Food & Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS). As part of the ACR’s annual Advocates for Arthritis earlier this month, the College’s Executive Committee met with FDA Commissioner Marty Makary, MD, MPH, at the Department of Health & Human Services headquarters on May 6. The Executive Committee met with CMS Deputy Administrator Christoper Klomp on May 20.
Meeting with FDA Commissioner Makary
Commissioner Makary, a pancreatic oncologist from Johns Hopkins University, was confirmed to head the FDA earlier this year and is well-known for his criticisms of COVID lockdowns and vaccine mandates. The meeting was an informal discussion that centered around how the Trump Administration’s FDA agenda for the next four years will juxtapose with the ACR’s policy priorities, particularly on issues related to vaccines, biosimilar development and approval, interchangeability status and drug importation.
Commissioner Makary began the discussion by extolling the FDA’s professional staff and promising to apply good science and common sense in the service of attacking chronic disease in the U.S., including by studying food additives and chemicals that could be contributing to poor health. He also reiterated his desire for a leaner, more efficient FDA focused on streamlining the development and approval of life-saving drugs, as well as for developing a framework for the continued study of these drugs post-approval. On vaccines, he teased a regulatory framework that focuses more on delivering vaccines to vulnerable populations and on studying the impact of boosters on these populations vis-à-vis healthier people.
ACR President Carol Langford, MD, led off the College’s comments by outlining concerns related to vaccine hesitancy, access to biosimilars and the future of interchangeability status, the FDA’s oversight of switching at the pharmacy counter, and drug importation. Questions and thoughts from Executive Committee members alluded to how the lack of access to vaccines impacts the rheumatic disease population, as well as the point-of-care decisions rheumatologists must often make when treating these patients, namely those on immunosuppressant medications. Concerns were also raised about the future of interchangeability status for biosimilars and how the underwater biosimilars issue is impacting the delivery of care.
Meeting with Christoper Klomp, Deputy CMS Administrator
Although the ACR was not able to schedule a meeting with newly confirmed CMS administrator Mehmet Oz, MD, during the fly-in, a meeting was held May 20 with Christoper Klomp, CMS deputy administrator. He is also director of the Center for Medicare. Among the issues Executive Committee members discussed were physician reimbursement, telehealth, the Medicare Drug Price Negotiation Program and Medicare Advantage. In addition, the Executive Committee sought to learn more about the Trump administration’s agenda for Medicare and Medicaid over the next four years. Of note, questions were raised about the objectives and structure of the recently revived Most Favored Nation Policy, which markets it would target and how it would impact rheumatology.
The ACR holds meetings with executive agencies, such as the FDA and CMS, to give rheumatology a strong voice in regulatory policymaking and to ensure that regulators have a full grasp of how regulatory oversight, or lack thereof, impacts rheumatologists and their patients. As such, we often reach out to members to take part in these meetings so their perspectives and expertise from the field can be heard. These meetings with regulators can strengthen the synergy we have on issues of agreement and develop a constructive dialog on issues of disagreement.
ACR/ARP members with concerns or issues related to FDA or CMS regulations, or who are interested in participating in a meeting with these agencies, should email the ACR’s advocacy team at [email protected]. We will continue to keep members fully informed on our discussions with these agencies, as well as on any regulations from them that may impact the practice of rheumatology.
