Statement from the Patients' Alliance for Drug Safety Protections on the Need for Restricted Distribution Systems for High-Risk Medicines

WASHINGTON, March 4, 2016 /PRNewswire-USNewswire/ -- The Patients Alliance for Drug Safety Protections (Alliance), a coalition of 19 public health, patient advocacy, health professional and disease organizations, today issued the following statement in response to an Associated Press story regarding the alleged misuse of closed restricted distribution systems for certain drugs.

"Any discussion about restricted distribution systems for certain drugs must start with a differentiation between closed restricted distribution systems that are required by the Food and Drug Administration (FDA) and those that are put into place by individual companies. For patients with diseases like cancer, kidney disease, and multiple sclerosis, FDA-mandated Risk Evaluation and Mitigation Strategies (REMS) programs make it possible for patients with diseases like cancer, kidney disease, and multiple sclerosis to have access to valuable medicines that would not otherwise be on the market due to very serious safety risks.

However, the need for these programs is limited to high-risk medicines known to cause life-threatening complications, liver damage, birth defects, severe allergic reactions and infections, if not carefully controlled. In these situations, FDA can require stringent safety precautions called "Elements to Assure Safe Use," including a restricted distribution system, to ensure the benefits of a needed medicine outweigh the drug's risks.

Currently, of the 1,100 brand drugs approved by the FDA, only 41 medications are subject to REMS with "Elements to Assure Safe Use" and an even smaller number require restricted distribution systems. In these rare situations, ensuring safety and public health must remain the primary goal. While the Alliance supports bringing more generic drugs to market, restricted distribution systems as part of a REMS program are an essential tool to advance patient safety, protect public health, and provide access to innovative medicines that would otherwise not be available. 

It is clear that the issue of REMS is complex but its value is very clear. Speaking on behalf of patients who only have access to needed medicines due to REMS safeguards, Alliance holds the position that REMS programs, including restricted distribution systems, are essential drug safety mechanisms, and should not be weakened."

Patients Alliance for Drug Safety Protections is a coalition of national 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. Learn more at www.drugprotections.org.

SOURCE Patients Alliance for Drug Safety Protections

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http://www.drugprotections.org