BETHESDA, Md., May 26 /PRNewswire/ -- On May 27 and 28, 2009, the Food and Drug Administration (FDA) will hear testimony about the FDA-guided effort to develop a classwide Risk Evaluation and Mitigation Strategy (REMS) for all controlled-release opioids from more than 70 patients, scientists, public health professionals, and representatives of pharmacist groups, prescriber groups, and pharmaceutical companies. Controlled-release opioids include prescription pain medications that release the medication over a period of several hours and contain fentanyl, hydromorphone, methadone, morphine, oxycodone, or oxymorphone. More than 21 million prescriptions are written every year for these medications.
Congress established REMS in the Food and Drug Administration Act of 2007 (FDAAA). Under FDAAA, for the first time FDA can require pharmaceutical companies to develop communication plans and other tools to minimize the risks associated with a medication while maintaining the medication's benefits. These tools may be educational, such as letters to prescribers reminding them of certain safety precautions. FDA can also, for example, require special certification of prescribers, limit dispensing to certain pharmacies, or require that prescribers or patients enroll in a registry.
Unlike most REMS, in which it is the patient who both benefits and is potentially at risk, for this REMS the people at risk include patients and non-patients, those who misuse or abuse the drug and are not prescribed the medication. This raises important questions about whether a REMS can both protect patients to whom a medication is prescribed and minimize use by non-patients.
|SOURCE Pinney Associates|
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