Alerts

FDA and Pharmacy Weekly Digest - October 1

Alerts / October 1, 2019
Food/Dietary Supplements

Acting FDA Commissioner Discusses Food Safety Modernization Act (FSMA) Progress – Acting Commissioner Sharpless announced the Food Safety Dashboard as part of the FDA-TRACK, “which is one tool the FDA uses to monitor certain FDA programs through key performance measures and projects, and regularly updates to ensure transparency to the public.” The hope is that the program will establish trends in compliance. The acting commissioner stated, “We know that we can’t stop every outbreak of foodborne illness; however, reducing the incidence of illness and death attributed to contaminated food is a shared goal of growers, manufacturers, packers, suppliers, importers and regulators alike. This goal can be realized through the successful implementation of FSMA and modernizing our approaches to food safety from farm to fork.”

Drugs/Biologics

FDA Approves Smallpox and Monkeypox Vaccine – The FDA announced the approval of the first live, nonreplicating vaccine for smallpox and monkeypox. The FDA stated the vaccine is “for the prevention of smallpox and monkeypox disease in adults 18 years of age and older determined to be at high risk for smallpox or monkeypox infection. This is the only currently FDA-approved vaccine for the prevention of monkeypox disease.”

FDA Announced Recall of Ranitidine – The FDA issued a press release announcing the recall of certain ranitidine products due to a potential impurity. The FDA stated, “This recall is due to a nitrosamine impurity, N-nitrosodimethylamine (NDMA), which was found in the recalled medicine. NDMA is classified as a probable human carcinogen (a substance that could cause cancer).”

Medical Devices

FDA Takes Steps Toward Advancing Digital Health Policies – The FDA announced the availability of two guidance documents, including a revised Clinical Decision Support Software draft guidance and a final guidance, Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act. The FDA stated that “these important guidance documents being issued today expand on our efforts to both encourage innovation in the ever-changing field of digital health and protect the public health. Our aim is to provide more clarity on our risk-based approach to digital health products, and, in particular, to provide more detail on those technologies and applications that would no longer be classified as a medical device subject to FDA regulation according to the Cures Act. These documents are critical elements of FDA’s comprehensive approach to digital health. We are committed to promoting beneficial innovation in this space while providing appropriate oversight where it’s merited.”

FDA Releases Four Additional Guidance Documents Relating to Medical Device Software – The guidance documents cover mobile medical apps, off-the-shelf software for use in medical devices, medical device data systems and wellness devices.

FDA Seeks to Address Potential Medical Device Safety Questions – To further its goal to address medical device safety, the FDA stated, “Today we’re announcing the next steps the agency is taking as part of its ongoing work to better evaluate the safety of specific materials used in medical devices. This includes holding our first public advisory committee meeting to convene experts and the public on this issue and providing new information on scientific evidence pertaining to specific materials – metals and metal alloys – used in medical devices.”

Tobacco

Acting FDA Commissioner Provides Testimony at Vape Hearing – Acting Commissioner Sharpless testified before the U.S. House Energy and Commerce Subcommittee on the regulation of e-cigarettes and about vape-related illnesses. The acting commissioner stated, “Working with state partners, FDA and [the Centers for Disease Control] have been investigating an outbreak of severe lung injury associated with the use of vaping products. Most cases have reported recent use of vaping products containing THC, the psychoactive ingredient in marijuana. Although these cases seem similar, it is not clear if they have a common cause, or if they have differing pathogenesis with similar presentation. The investigation has not identified any specific substance or product that is linked to all cases.”

Pharmacy

FDA and Drug Enforcement Agency Warn About Online Opioid Sales – The agencies issued a number of joint warning letters to website operators alleging that the websites were “illegally marketing unapproved and misbranded versions of opioid medicines, including tramadol, that are potentially dangerous. The warning letters issued to each of the networks state that they must immediately stop illegally selling these opioids to American consumers. This joint action demonstrates the federal government’s commitment to enhance interagency coordination to respond to the opioid crisis.”

Florida Submits Drug Importation Plan – Florida submitted the Canadian Prescription Drug Importation Paper to Health and Human Services in late August, indicating that it has every intention to start an importation program.

Authorship Credit: Lindsay P. Holmes

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