REMS cut new drug channels

Risk evaluation and mitigation strategies--mandated measures to ensure the safe use of certain drugs--may be driving changes in drug distribution.

Using so-called restricted distribution as a REMS component, manufacturers are bypassing traditional distributors and shipping to patients or otherwise minimizing the number of handoffs between factory and home. Overnight delivery services--especially those using package tracking technologies--are being called up.

Jazz Pharmaceuticals used a restricted distribution technique in its REMS program for the narcolepsy treatment, Xyrem. The drug is a diversion risk because it is prone to abuse. The Xyrem REMS program includes a restricted distribution network: a central pharmacy that ships drugs directly to the patient, reports Securing Pharma.

And Biogen Idec, responding to a serious side effect associated with its multiple sclerosis treatment Tysabri, restricts the drug's distribution network as one REMS element; a physician certification program and patient registry are additional elements.

The FDA issued draft guidance on REMS last fall, as we reported.

- see the article

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