FDA announcements touch upon healthcare packaging and regulatory issues

Agency addresses increasing complexity of FDA’s mandate, globalization in the supply chain, and the trend of rapid scientific innovation.

In her Oct. 7 blog in FDAVoice, U.S. FDA Commissioner Margaret A. Hamburg, M.D., reported on regulatory programs and action plans, each of which “describes the steps in transitioning to commodity-based and vertically-integrated regulatory programs in the following areas: human and veterinary drugs; biological products; medical devices and radiological health; bioresearch monitoring (BIMO); food and feed; and tobacco.”

She noted, “These action plans focus on what will be accomplished in FY 2015 and outline the need to develop detailed future plans for the next five years in some cases. The plans represent what each Center and ORA [Office of Regulatory Affairs] have agreed are the critical actions to jointly fulfill FDA’s mission in the key areas of specialization, training, work planning, compliance policy and enforcement strategy, imports, laboratory optimization, and information technology.”

New features of the plans include establishing Senior Executive Program Directors in the ORA, jointly developing new inspection approaches, investing in expanded training across ORA and the FDA centers, expanding compliance tools, optimizing FDA laboratories, and creating specialized investigators, compliance officers, and first-line managers.

About a week earlier, Hamburg’s column announced the release of a “FDA Strategic Priorities: 2014-2018” to better address what she described as a world in which FDA operates as “one of growing complexity, new challenges, and increased risks. And thanks to revolutionary advances in science, medicine, and technology, we have enormous opportunities that we can leverage in order to overcome many of these challenges for the benefit of public health.”

Labeling approval

The agency on Oct. 17 also announced that it “approved new labeling for Embeda (morphine sulfate and naltrexone hydrochloride) extended-release (ER) capsules, an opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Embeda is the third ER opioid analgesic to be approved with labeling describing the product’s abuse-deterrent properties consistent with the FDA’s 2013 draft guidance, “Abuse-Deterrent Opioids—Evaluation and Labeling.” The new labeling includes a claim indicating that Embeda has properties that are expected to reduce oral abuse when the product is crushed.”

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