From The College May 2006

The complete newsletter is available in PDF format, below.

Featured Article

ACR Formalizes Drug Safety Monitoring

Because drug safety is an area of increasing interest and concern to rheumatologists, the ACR Board of Directors, led by ACR President Mary K. Crow, MD, recently formed the Drug Safety Committee.

The goals of the committee are: to communicate with the FDA about mutual areas of interest; to plan educational programs about drug safety directed to rheumatologists and rheumatology health professionals; and, to serve as a quick response team to communicate and interpret new drug safety data to our members.

On March 6, Dr. Crow and members of the Drug Safety Committee met with Dr. Janet Woodcock, the Deputy Commissioner of the FDA, and Dr. Jim Witter, a rheumatologist at the FDA’s Center for Drug Safety, to discuss areas in which the FDA and ACR can communicate and collaborate about drug development and safety. Specific issues raised included improved communication between rheumatologists and the FDA about drug safety activities and initiatives, and the challenges of developing effective post marketing surveillance programs. The Committee plans to continue regular discussions with the FDA in the coming year.

In addition, the Drug Safety Committee is planning a symposium on drug safety for the Annual Scientific Meeting in Washington, DC. Details will be available later in the summer. The committee is chaired by Steven Abramson, MD, and members include Drs. David Borenstein, Michael Weisman, Dan Lovell, Sherine Gabriel, and Lenore Buckley.