New drug safety alliance and website launched


Twenty healthcare provider organizations have joined together to establish a new coalition, The Patients Alliance for Drug Safety Protections, to advance the knowledge of Risk Evaluation and Mitigation Strategies (REMS) as a vital tool to improving public health and patient safety.

Representing millions of Americans with serious diseases like cancer, kidney disease, and multiple sclerosis who currently benefit from medicines marketed with these drug safety measures, the Alliance will serve as an information resource on the value and need for REMS at a time when there is an extensive knowledge gap among patients, policymakers, and other key stakeholders about the current REMS system.

Among the coalition's priorities is to raise awareness that REMS allows the Food and Drug Administration (FDA) to approve valuable medications that would otherwise not be on the market while preventing drug diversion – a growing concern to regulators and the public health community in light of the growing black market for certain addictive or abused medications.

The Alliance is spearheaded by the Society for Women's Health Research (SWHR) and is comprised of the following public health, women's health, health professional and disease organizations: the Alliance for the Adoption of Innovations in Medicine, American Association of Kidney Patients, American Cancer Society Cancer Action Network, American College of Obstetricians and Gynecologists, Association of Reproductive Health Professionals, C-Change, Center for Lawful Access and Abuse Deterrence, Consortium of MS Centers, Cutaneous Lymphoma Foundation, HealthyWomen, International Myeloma Foundation, Leukemia & Lymphoma Society, March of Dimes, MDS Foundation, Multiple Myeloma Research Foundation, National Association of Nurse Practitioners in Women's Health, Organization of Teratology Information Specialists, Patients Rising, and the Teratology Society.

"Several conditions require access to treatments that may have significant risk factors. Without the protections created by REMS programs, these drugs would not be allowed on the market and patients would suffer tremendously," said Phyllis Greenberger, SWHR president and chief executive officer.

"This Alliance was established in coordination with knowledgeable and experienced advocates for patients and physicians who are worried about recent efforts to weaken REMS protections, putting public health and patient access at risk."

To underscore the value of REMS to public health, the Alliance unveiled a new online resource that translates the latest facts about the REMS program in layman's terms.

The Patients Alliance for Drug Safety Protections, Society for Women's Health Research, Phyllis Greenberger, US