United States: FDA And Pharmacy Weekly Digest - June 26

Food/Dietary Supplements

FDA Announces Guidance on Added Sugar Labeling – The FDA published a new guidance for labeling of added sugars. The guidance provides "clarification for companies that produce single-ingredient sugars and syrups, in addition to those who produce cranberry products. Single-ingredient sugars are intended to be consumed alone or added to foods by consumers, and thus will be an added sugar to the diet when consumed. As companies who produce these products began to look at how they would implement the new label, they raised concerns about how consumers would perceive the Added Sugars declaration on their product labels."

FDA Publishes Guidance on the "Small Business" Definition – The guidance is intended to "help industry subject to Title 21 of the Code of Federal Regulations (21 CFR) part 117 (part 117) or 21 CFR part 507 (part 507) determine the number of employees for purposes of the 'small business' definition under parts 117 and 507."

FDA Releases Guidance on Production of Seed for Sprouting – The FDA issued a draft guidance titled "Reducing Microbial Food Safety Hazards in the Production of Seed for Sprouting." The guidance "is intended to make the sprout seed industry (seed growers, conditioners, packers, holders, suppliers and distributors) aware of FDA's serious concern with the continuing outbreaks of foodborne illness associated with the consumption of raw and lightly-cooked sprouts and to provide our recommendations to firms throughout the production chain of seed for sprouting."

Drugs/Biologics

FDA Approves Pediatric Type 2 Diabetes Treatment – The FDA announced the approval of an injectable treatment for pediatric patients with type 2 diabetes. The product is the "first non-insulin drug approved to treat type 2 diabetes in pediatric patients since metformin was approved for pediatric use in 2000."

FDA Seeks to Improve Transparency for Generic Drug Applicants – The FDA announced it is "enhancing the Paragraph IV Patent Certifications List by adding several additional data points, including the status of any 180-day exclusivity decisions for individual drug products, along with other information about the dates of first approval, marketing status and expiration dates of blocking patents. Providing this information may help subsequent generic drug applicants determine when their products can be approved and marketed."

FDA Comments on Opioid Analgesics – The FDA released a statement on the framework for evaluating certain opioid products. The FDA indicated "our goal has been to ensure product approval and removal decisions are science-based and that the agency's benefit-risk framework considers not only the outcomes of prescription opioids when used as prescribed but also the public health effects of inappropriate use." In addition, the FDA published a draft guidance titled "Opioid Analgesic Drugs: Considerations for Benefit-Risk Assessment Framework Guidance for Industry."

FDA Publishes Guidance on Prescription Drug Labeling – The FDA issued a final guidance titled "Providing Regulatory Submissions in Electronic and Non-electronic Format – Promotional Labeling and Advertising Materials for Human Prescription Drugs." The guidance focuses on "submissions of promotional materials for human prescription drugs ... to the Food and Drug Administration (FDA or Agency) made by manufacturers, packers, and distributors (firms), whether the applicant or an entity acting on behalf of the applicant. Specifically, this guidance pertains to submissions made to the Office of Prescription Drug Promotion (OPDP) in the Center for Drug Evaluation and Research (CDER) and the Advertising and Promotional Labeling Branch (APLB) in the Center for Biologics Evaluation and Research (CBER)."

Medical Devices

FDA Endeavors to Increase Medical Device Reporting Transparency – The FDA announced the official end to the Alternative Summary Reporting Program and the implementation of the Voluntary Malfunction Summary Reporting (VMSR) Program. The FDA stated, "The VMSR Program enables the FDA to efficiently detect potential safety signals and free up resources to better focus on addressing the highest risks, such as deaths and serious injuries, associated with medical devices. This voluntary program allows manufacturers to report certain device malfunctions in summary form on a quarterly basis, rather than on an individual basis, for eligible device types. Reports from this voluntary program are publicly available in the MAUDE database."

Tobacco

PATH Study Reviews Tobacco Use – The FDA published the findings of a Population Assessment of Tobacco Health (PATH) study. The "study offers unique insights into youth use of flavored tobacco products, the health effects of e-cigarettes, and adult use of cigars and hookah."

Pharmacy

Oregon Passes PBM Legislation – This comprehensive legislation is focused on pharmacy benefit managers (PBMs). The legislation includes a number of provisions protective of pharmacy, including prohibiting a requirement that a prescription be filled or refilled by a mail-order pharmacy as a condition for reimbursing the cost of the drug.

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