US Senators Write Letter to FDA with Concerns of Zohydro – Urge FDA to Expedite Review of Painkillers with Built-in Properties to Curb Abuse.

Following the FDA’s controversial release of Zohydro, Commissioner Margaret Hamburg, Senate Judiciary Committee Chairman Patrick Leahy (D-Vt.), and US Senator Richard Blumenthal (D-Conn.) expressed their concerns in a letter to the Food and Drug Administration (FDA) urging the FDA to take all available measures to ensure that patients are soon provided safer alternatives to pure opiate products like Zohydro. The letter requested an expedited review of painkillers with built-in abuse deterrent properties to curb addiction to these medications. The letter also directly addressed concerns for the release of Zohydro, noting Zohydro ER was the first pure hydrocodone product to receive FDA market approval, and that the drug was approved despite lacking any abuse-deterrent properties and over strong objections from the FDA’s own independent advisory committee. The senators concluded by requesting that the FDA brief their staff on plans to monitor the use of Zohydro ER, including what metrics will be used to potentially reevaluate its status as an approved drug if problems develop. Additionally, the senators charged the FDA with the responsibility of planning efforts to curb prescription drug abuse in general, by requesting to be kept in the loop as plans develop. Mel Pohl, MD, FASAM, Medical Director of Las Vegas Recovery Center said, “Zohydro ER should never have been released, in my opinion. Perhaps with heightened scrutiny by the FDA or some external body, should the expected overdoses and abuse of the drug occur, it will be nipped in the bud before too many people die.”