FDA Commissioner Margaret Hamburg told House lawmakers Wednesday (March 4) that a guidance on evaluation and labeling of abuse-deterrent opioid drugs will be finished by appropriators’ June 30 deadline — or possibly even sooner. Lawmakers in the end-of-year spending package withheld $20 million from FDA’s Office of the Commissioner pending completion of the 2013 guidance, and said that if FDA didn’t meet the June 30 deadline the funds would be transferred to the agency’s Office of Criminal Investigation.
“The abuse-deterrent guidance, will be out by the date that you have indicated, in fact we think well before,” said Hamburg to House Appropriations Committee Chairman Hal Rogers (R-KY), who was asking about FDA efforts to curb prescription opioid abuse. “We will be laying out clearly and explicitly for industry our expectations for what kind of studies need to be done; what kind of data needs to be collected to demonstrate an abuse deterrent effect; how best to go about creating these products with abuse deterrent properties that can measurably make a difference so that these prod- ucts are harder to abuse.”
Rogers questioned Hamburg as to whether this guidance will incentivize the private sector to “bring better products forward,” adding that FDA staff has indicated that, despite five abuse deterrent products on the market, uptake of these medications has been slow.
Hamburg said that in addition to FDA working with industry and the scientific community, insurers and the healthcare community need “to step up to the plate to insist on better formulations as well.”This comes shortly after the Center for Drug Evaluation and Research updated its draft guidance agenda for this coming year to include a generic drug guidance for evaluating abuse-deterrent properties of generic opioid drug products. — Erin Durkin
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