November 10-15

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FDA representatives will provide updates on safety issues, pediatric rheumatology, package inserts


4 minutes

Representatives from the U.S. Food and Drug Administration will provide important updates for the rheumatology community on Monday, Nov. 8, and Tuesday, Nov. 9, at ACR Convergence 2021. Three sessions over the two days will focus on safety issues, pediatric rheumatology, and the importance of bidirectional communication throughout the patient care cycle.

Michael Weisman, MD
Michael Weisman, MD

“Many of the speakers are clinicians and rheumatologists in addition to their service at the FDA,” said Michael Weisman, MD, Adjunct Professor of Medicine at Stanford University and Distinguished Professor of Medicine Emeritus at the University of California, Los Angeles, David Geffen School of Medicine. “They understand that there can be conflicts between what is a regulatory decision and what is a clinical decision. They come to this meeting to explain the regulatory aspects of their decision-making that oftentimes gets missed or misinterpreted in the heat of the discussion.”

Dr. Weisman will moderate the first of two FDA sessions on Monday. FDA Update on Safety Issues in the Treatment of Rheumatic Disease, which will be held from 9:30 – 10:30 a.m. ET, will feature updates on late-breaking and evolving topics related to patient safety, including relevant FDA analyses and responses to current issues.

The session is a rare opportunity for FDA insiders to discuss policy decisions that are based on presentations at workshops that are closed to the public. Don’t expect proprietary disclosures, Dr. Weisman cautioned, but panelists will share pertinent case studies and examples that may not be familiar to rheumatologists.

“Clinicians need to understand what it means when a drug is approved or not approved by the FDA,” he said. “We need to understand decisions in a regulatory sense because clinicians are continuously negotiating with insurance companies who are paying for drugs, or not, and with patients concerned about safety and efficacy. It’s extremely important for us to understand the distinctions and nuances of FDA approval and what approval actually means in our daily practice so we can more fully advise our patients.”

The safety update will be followed by Pediatric Rheumatology FDA Update from 10:30 – 11:15 a.m. ET Monday. FDA representatives will discuss drug safety issues specific to pediatric rheumatology and provide the FDA perspective on pediatric drug shortages.

Yeruk (Lily) Mulugeta, PharmD,
Yeruk (Lily) Mulugeta, PharmD

“Our goal is to make emerging drug safety information available in a balanced manner so that healthcare professionals and patients can consider the information when making decisions about medical treatment despite uncertainties in the data,” said session moderator Yeruk (Lily) Mulugeta, PharmD, FDA Clinical Reviewer in the Division of Pediatric and Maternal Health. “FDA recently issued a Drug Safety Communication related to new safety signals for tofacitinib, a JAK inhibitor approved for polyarticular-course Juvenile Idiopathic Arthritis, and also for rheumatoid arthritis and psoriatic arthritis.”

Dr. Weisman will return to moderate the third FDA session, The Package Insert: Patient Care Cycle: Bidirectional Communication with the FDA, from 2 – 3 p.m. ET Tuesday. Every member of the healthcare team recognizes the importance of package inserts, he noted, but they may be less familiar with the many ways that postmarketing pharmacovigilance can enhance patient safety, or how spontaneous adverse event reporting gives providers a way to leverage their own clinical experience to influence safety labeling updates.

“Unlike in Europe, there are no mandated ways to collect postmarketing data in the United States,” Dr. Weisman said. “Hospitals, drug companies, insurance companies, and others collect data, but each collects data in a different way with their own goals in mind. Spontaneous adverse event reporting from clinicians has provided some very useful information that would not be picked up in other ways. When you are doing a scientific review of a specific agent, for example, these events can be picked up and publicized rather immediately. Every source of information has its peculiarities, benefits, and drawbacks, but they are all valuable.”


If you haven’t registered for ACR Convergence 2021, register today to access all of the valuable content during the meeting, November 3–10. Registration also includes on-demand access to the virtual platform (session recordings, Poster Hall, Community Hubs, and ShowRheum) until March 11, 2022.