New Drug Safety Alliance and Website Launched to Preserve REMS Safeguards

WASHINGTON, Oct. 20, 2015 /PRNewswire-USNewswire/ -- Twenty prestigious 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 CEO. "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 – www.drugprotections.org – that translates the latest facts about the REMS program in layman's terms. Designed for ease of use, the online hub summarizes the history and purpose of REMS, what REMS entails and the number of medicines now marketed with a REMS. In addition, the website provides links to information about REMS from FDA and other reputable source and will serve as a clearinghouse for the coalition's policy materials.

"The American College of Obstetricians and Gynecologists (ACOG) is a proud member of the coalition to advance the importance of REMS as a tool to improve public health," said Mark S. DeFrancesco, MD, ACOG president. "As the nation's leading group of physicians providing health care for women, we recognize the importance of drug safety measures, particularly to prevent severe complications and birth defects that can result from inappropriate medicine distribution and use. We encourage healthcare organizations to work collaboratively to design and conduct drug studies in order to ensure that people with serious diseases have access to appropriate treatments."   

Among the priority issues for the Alliance will be to preserve the integrity of safety programs like REMS with Elements to Assure Safe Use (ETASU). Drugs that are covered by REMS with ETASU face the greatest set of restrictions, including the use of registries, education programs for providers, pharmacies and patients, monitoring, and restrictions on distribution. Although these programs can add time and administrative requirements for health professionals and can be expensive for manufacturers to develop and operate, these extensive safety measures are required by the FDA under federal law to ensure that a drug's benefits will outweigh its risks. ETASU components are rare, as only 36 drugs as to date have these programs.

"The Consortium of MS Centers values REMS with ETASU. Without it, valuable and efficacious treatments for people with multiple sclerosis would have disappeared completely," said June Halper, MSN, APN-C, MSCN, FAAN and the Consortium's CEO. "Through our work with other MS advocacy organizations dedicated to all those affected by MS, the FDA developed a REMS with ETASU for a therapy that is now one of the significant tools we utilize to treat some patients with MS."

Besides serving as an information resource for policymakers and the public, the Alliance will support advocacy efforts to preserve patient access, prevent the weakening of all REMS programs; and ensure that manufacturers – innovator companies and generic manufacturers – are held to the same safety requirements when designing and conducting drug studies.

About the Patients Alliance for Drug Safety Protections

Patients Alliance for Drug Safety Protections is a coalition of 20 public health, patient advocacy, health professional and disease organizations working collaboratively to raise awareness of the importance of REMS as a tool to advance patient safety and protect public health.  Spearheaded by the Society for Women's Health Research, other members of the coalition are: 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.