BakerHostetler FDA and Pharmacy Weekly Digest - March 4, 2019

Alerts / March 4, 2019
Food/Dietary Supplements

FDA Releases Imported Food Safety Strategy – The FDA announced its imported food safety strategy. The FDA statement indicates that the strategy is set to address four goals: “preventing food safety problems in the foreign supply chain prior to entry into the U.S.; effectively detecting and refusing entry of unsafe foods at U.S. borders; responding quickly when the FDA learns of unsafe imported foods; and measuring our progress to ensure that our imported food safety program remains effective and efficient.”

FDA Discusses CBD in Food with Congress – Commissioner Gottlieb spoke before the House Appropriations Committee to address the status of CBD. CNBC reported that FDA reiterated its focus on the regulation of CBD and its plans to propose a strategy to move forward.


Commissioner Gottlieb Testifies Before the Committee on Appropriations – FDA Commissioner Gottlieb gave public testimony to the U.S. House Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies on FDA’s FY19 budget. The commissioner’s statement included a discussion of Investigational New Drug Applications and FDA’s Adverse Event Reporting System.

FDA Issues Warning Letter to Canadian Distributor for Selling Unapproved Drugs – The FDA issued a warning letter to a Canadian firm for “caus[ing] the introduction of unapproved new drugs and misbranded drugs into interstate commerce.” The letter alleges that the facility acts as a broker between foreign pharmacies and employer-sponsored health plans in the U.S. FDA alleges that the facility “has designed its business to operate in a manner that substitutes the FDA-approved drugs prescribed by the U.S. healthcare provider with unapproved drugs.”

FDA Announces New Approach to Pharmaceutical Manufacturing – In its press release, the FDA discussed continuous manufacturing (CM), which “transforms the traditional, step-wise manufacturing processes into a single system that’s based on modern process monitoring and controls. It enables a steady output of finished drug products as raw materials are continuously added to the closed system.” The FDA hopes to spur the adoption of CM. The FDA coupled this announcement with the publication of a draft guidance on the subject titled “Quality Considerations for Continuous Manufacturing.”

FDA Discussed 2019 Agenda to Address Opioid Abuse – The FDA released a statement outlining its 2019 policy and regulatory agenda to address the opioid abuse epidemic. FDA’s agenda outlines steps it plans to take, including (1) reducing misuse and abuse of opioids; (2) supporting addiction recovery and reducing overdose deaths; (3) supporting research and innovation in nonaddictive pain therapies; and (4) strengthening enforcement related to the marketing and distribution of illicit opioid.

FDA Chief of Staff Remarks on Advertising and Promotion Policy – At the DIA Advertising and Promotion Regulatory Affairs Conference, Lauren Silvis made remarks about the FDA’s plans to modernize its policies related to “labeling, advertising, promotion, and other communications about medical products.” Ms. Silvis stated that the FDA is “taking important steps to ensure that labeling effectively communicates well-curated, up-to-date information; that rules relating to advertising and promotion are clear, thoughtful, and well-tailored; and that we are providing clear and helpful guidance on how to communicate truthful and non-misleading information about regulated products.”

Medical Devices

FDA Warns Consumers About Thermography Devices – The FDA issued a public announcement warning consumers to avoid thermography devices to detect breast cancer. The FDA warned that these devices are not FDA-cleared as an alternative to mammography. FDA also issued a warning letter to a clinic marketing these uncleared technologies.

FDA Announces Launch of Diagnostic Test Task Force – The FDA, along with the CDC and CMS, announced the launch of the Tri-Agency Task Force for Emergency Diagnostics. The FDA’s announcement indicates the “task force has been created to help leverage the expertise of each agency to advance rapid development and deployment of diagnostic tests in clinical and public health laboratories during public health emergencies.” The FDA hopes to make diagnostic tests available quickly to respond to health emergencies like Ebola and Zika.


FDA Issues Final Bulk Guidance – The FDA released a final guidance titled “Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act.” The final guidance outlines the criteria by which the FDA will evaluate bulk substances for inclusion on the 503B bulks list.

FDA Releases Final Register Notice on Certain Bulk Substances – The FDA issued a federal register notice indicating that it has considered two bulk substances for the 503B bulks list and has determined that the list will not include these substances. The substances are nicardipine hydrochloride and vasopressin.

Authorship Credit: Lindsay P. Holmes

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