2. Timely communication to ACR members about safety issues: One of the main uses of the ACR Hotline is providing expert guidance to members within days to weeks when a new drug safety issue explodes. Other educational strategies include sessions at the ACR Annual Scientific Meeting devoted to drug safety and ACR white papers, like the one on NSAIDs.
3. Support for the development of new knowledge: The ACR Research and Education Foundation (REF)—both through its core programs and through Within Our Reach, its targeted RA research initiative—seeks to foster translational and clinical research that includes development of better outcomes measures and improved drug safety monitoring.
4. An informed leadership: Repeated appearances by Janet Woodcock, MD, one of the highest ranking officials in the FDA (and also a rheumatologist), at ACR board meetings have gone a long way toward creating a better informed ACR leadership. Dr. Woodcock’s presentations have been substantive, forward-looking, and targeted to our interests and concerns. Other pertinent activities of ACR officers, Government Affairs Committee (GAC) volunteers, staff, and advocacy consultants include careful study of the many bills introduced into Congress over the past two years that bear on drug safety.
5. Establishment of an ACR Committee on Drug Safety: This subcommittee of the QOC was established two years ago and is tackling a challenging agenda of drug safety issues.
Key roles for this committee are to maintain a dialog with the FDA on drug safety concerns that pertain to rheumatology, develop training opportunities in drug safety research for rheumatology fellows and faculty, and devise ways to keep ACR members informed on a broad spectrum of drug safety developments. (A survey on these issues may be finding its way to your e-mail box soon.) This subcommittee will also assist the GAC and staff to monitor legislation related to drug safety and help develop drug safety educational sessions for ACR meetings.
6. Formulation of position statements: The ACR has developed a position statement on the issue of generic biologics (also called biosimilars or follow-on biologics), which is available on the ACR Web site and has been communicated to key members of Congress who are active on this issue. It emphasizes the need for ensuring safety as well as efficacy as new agents are brought forward, and the importance of handling this as a scientific issue, not a political one.
7. Participation in future cardiovascular guidelines that impinge on rheumatology: ACR members are well aware of the recent publication of guidelines for use of NSAIDs in treating arthritis by the cardiovascular community that, from our perspective, did not reflect sufficient understanding of rheumatic diseases or their appropriate treatment. Earlier this year ACR and REF leadership met with Elizabeth Nabel, MD, Director of the National Heart, Lung, and Blood Institute (NHLBI), to explore opportunities for funding rheumatic disease research through the NHLBI. An unexpected bonus outcome of this very successful meeting was an invitation to designate rheumatologists to serve on oversight committees that the NHLBI is establishing to supervise cardiovascular guidelines development. Two ACR members have already been placed into these positions, and we view this as a substantial step towards an appropriate voice for the rheumatologist—and for patients with arthritis—in the creation of future guidelines on topics such as use of NSAIDs.
