United States: BakerHostetler FDA And Pharmacy Weekly Digest - December 10, 2018

Food/Dietary Supplements

FDA Issues Avocado and Hot Pepper Sampling Reports – The Food & Drug Administration (FDA) has made available two reports related to the sampling of avocados and hot peppers for the presence of certain bacteria.

FDA Releases Food Code Report – The FDA released a report addressing the adoption by state and territorial authorities of the FDA’s model Food Code for 2017.

FDA Seeks Feedback on International Adulteration (IA) Rule – As part of the three-part draft IA rule, the FDA is allowing additional time for comments on the first installment of the IA rule as well as opening a new comment period for the second installment. According to the FDA, the IA rule is “aimed at preventing intentional adulteration of food designed to cause wide-scale harm to public health, including terrorism targeting the food supply.”

FDA Investigates Vitamin D in Pet Food – As a result of several recalls, the FDA launched an investigation into potentially toxic levels of vitamin D in dry pet foods.

FDA Releases Menu Labeling Training Module – The FDA announced the availability of an educational module to help members of industry and consumers understand the requirements regarding menu labeling. The module addresses those establishments and foods that are impacted by the requirements and ways to comply with the requirements. Also available are two fact sheets related to menu labeling and calorie declaration.

FDA Warns About Hidden Drug Ingredients – The FDA issued two public notifications warning consumers not to purchase certain products promoted for sexual enhancement because they contain hidden drugs as active ingredients.


FDA Publishes Real-World Evidence Program – The FDA announced the availability of a framework for the FDA’s Real-World Evidence Program. This framework addresses the use of real-world evidence “to (i) help support the approval of a new indication for an already approved drug or (ii) help support or satisfy drug post-approval study requirements.”

Drug Manufacturers Issue Recalls – A drug manufacturer announced the voluntary recall of Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL. The recall was issued because lots “have been found to potentially have higher concentrations of ibuprofen.” Another manufacturer issued a voluntary recall of all lots of Valsartan-containing products within expiry “due to detected trace amounts of an impurity, N-nitrosodiethylamine (NDEA), contained in the API Valsartan.”

FDA Announces GDUFA Guidance – The FDA published a final guidance titled “Post-Complete Response Letter Meetings Between FDA and ANDA Applicants Under GDUFA.” The guidance makes recommendations on post-complete response letter meetings for ANDA applicants.

Medical Devices

FDA Commissioner Announces in Vitro Test Labeling Guidance – Commissioner Gottlieb announced the availability of a draft guidance document that aims “to make it easier to get class labeling on diagnostic tests for oncology therapeutic products, where scientifically appropriate.”

FDA Takes Renewed Interest in Laboratory Developed Tests (LDTs) – The FDA announced that the “FDA historically exercised enforcement discretion over most LDTs. But today, we need a unified approach to the regulation of in vitro clinical tests to protect patient safety, support innovation, and keep pace with the rapidly evolving technology that’s helping us find new treatments for disease. Patients rely on diagnostic test information to make decisions about their health regardless of who develops the test or where it comes from. We shouldn’t subject similar tests to different approaches just because they are made by different developers.”

FDA Recognizes Genetic Variant Database – The FDA announced the recognition of the first publicly available genetic variants database. The database “defines the clinical relevance of genes and differences in genes (variants) for use in precision medicine and research.”

FDA Seeks Feedback on de Novo Classification Process – The FDA issued a proposed rule that would establish specific requirements for the FDA’s medical device de novo classification process. The rule covers procedures and criteria for requests for de novo classification.

FDA Announces Innovation Challenge – The FDA launched a medical device innovation challenge in May 2018 to address opioid misuse and abuse. It published a list of eight applicants selected for “devices to prevent and treat opioid disorder.” Selected applicants will work with the FDA to speed up the development and marketing application review process.

FDA Aims to Increase Accuracy of Blood Glucose Monitors – The FDA announced the publication of two revised draft guidance documents related to blood glucose monitors. The guidance documents address additional design considerations and recommended standards. The FDA indicated that the documents are “part of the FDA’s continuing efforts to improve the development of new blood glucose meters based on feedback from both patients and health care providers, especially on the usability of glucose monitors.”

FDA Issues Dual 510(k) and CLIA Waiver Guidance – The FDA published a draft guidance to assist manufacturers in utilizing the “Dual 510(k) and CLIA Waiver by Application” pathway. The FDA’s guidance indicates that it “believes increased use of this pathway will speed up the process of bringing simple and accurate IVD devices to CLIA-waived settings, which will better serve patients and providers.”

Recently Posted Warning Letters

The FDA recently posted a warning letter alleging “significant violations of current good manufacturing practices” by a drug manufacturing facility. The FDA issued a warning letter to a beef cattle operation for “an animal for sale as food that was adulterated” due to the “presence of sulfamethazine at 0.756 parts per million (ppm) in the liver.” The FDA also issued a warning letter to a device manufacturer for allegedly failing to have a proper quality system in place.


FDA Releases Revised Draft on Human Drug Compounding – The FDA released a revised draft guidance titled “Current Good Manufacturing Practice – Guidance for Human Drug Compounding Outsourcing Facilities under Section 503B of the FD&C Act; Draft Guidance for Industry.” According to the unpublished version, the draft “describes FDA’s policies regarding compounders registered under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as outsourcing facilities and the current good manufacturing practice (CGMP) requirements in FDA regulations. Based on feedback from stakeholders and comments received on the initial draft guidance, the guidance is being revised, in part, to reflect further consideration of how CGMP requirements should be applied in light of the size and scope of an outsourcing facility’s operations.”

HHS Issues Final Rule Related to the Affordable Care Act – The U.S. Department of Health and Human Services (HHS) published a final rule titled “Patient Protection and Affordable Care Act; Adoption of the Methodology for the HHS-operated Permanent Risk Adjustment Program for the 2018 Benefit Year Final Rule.” The summary indicates “HHS is adopting for the 2018 benefit year an HHS-operated risk adjustment methodology that utilizes the statewide average premium and is operated in a budget-neutral manner.”

OMB Reviewing Rule Impacting PBMs – The Office of Management and Budget (OMB) is currently reviewing a proposed rule from the HHS’ Office of the Inspector General titled “Removal of Safe Harbor Protection for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection.” OMB reports that the notice of proposed rulemaking (NPRM) “would revise the discount safe harbor related to rebates to plans or pharmacy benefit managers involving pharmaceuticals. In addition, this NPRM proposes a new safe harbor.” This proposed rule is listed as economically significant.

Bipartisan Bill Aimed at the Medicaid Rebate Loophole – Sens. Wyden and Grassley introduced a bill set to empower the Medicaid program to take action against drug manufacturers it suspects have misclassified a brand drug as a generic.

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