United States: FDA and Pharmacy Weekly Digest - September 3

Food/Dietary Supplements

FDA Will Hold Public Meeting on Food Standards of Identity – The meeting will be held on Sept. 27, 2019, and is intended “to give interested parties an opportunity to discuss FDA’s effort to modernize food standards of identity and to provide information about changes the FDA could make to existing standards of identity. FDA is particularly interested in changes that could be made across categories of standardized foods, often referred to as horizontal changes, to provide flexibility for manufacturers to develop healthier foods.”

FDA Revisits Best Practices to Prevent Food Tampering and Intentional Adulteration – The FDA stated that it is “reminding industry of strategies to prevent tampering and intentional adulteration of foods and cosmetics in response to a few recent media reports of tampering of products in retail grocery stores.” Steps include inspection of products, systems to identify compromised product and continual monitoring.

FDA Testifies Before the Senate Committee on Agriculture, Nutrition, and Forestry – The principal deputy commissioner stated, “The first priority of the CBD Policy Working Group has been to obtain and assess safety data for CBD, given the Agency’s public health mission. Although FDA has approved one drug, Epidiolex, that contains CBD, Epidiolex is approved for use in a limited population at a specific dose, was studied for safety and efficacy in rigorous randomized clinical trials, and is available only by a prescription from a licensed medical professional. When considering the use of CBD in non-drug products, such as conventional foods and dietary supplements, FDA must evaluate different factors than for a prescription drug product. CBD food and dietary supplement products would be directly available to a wide range of consumers, which could potentially include pregnant or nursing mothers, children, the elderly, those with chronic illnesses, and those taking medications that might interact with CBD. CBD products could also be given to a wide variety of animal species, some of which are used for food. These would also be available without discussions with a doctor or other medical professional. Given this, FDA must consider the potential safety implications of long-term use of CBD by different human and animal populations.”

FDA Publishes Policy About Cranberry Products – The FDA released its “ Policy Related to Cranberry Products with Added Flavorings.” The policy informs “manufacturers of certain dried cranberry products with added flavorings of our intent to exercise enforcement discretion until July 1, 2020, for their compliance with the updated labeling requirements set forth in two final rules published in the Federal Register of May 27, 2016, entitled, “Food Labeling: Revision of the Nutrition and Supplement Facts Labels” (hereafter referred to as “Nutrition Facts label final rule” (81 FR 33742)) (see 21 CFR 101) and “Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments” (hereafter referred to as the “Serving Size final rule” (81 FR 34000)) (see 21 CFR 101).”

Drugs/Biologics

FDA Approves Add-on for Treatment of Certain Episodes Related to Parkinson’s – The FDA announced the approval of an add-on treatment of “off” episodes in adult patients with Parkinson’s disease.

FDA Continues Efforts to Address ARB Medication Safety Issues – The FDA reiterated its concerns about Angiotensin II Receptor Blocker (ARB) recalls. However, it clarified its concern by stating, “We would like to stress that the actual risk to patients is likely much lower than our estimates, which reflect a scientific assessment of the highest possible exposure. We initially estimated that if 8,000 people took the highest valsartan dose (320 mg) containing N-Nitrosodimethylamine (NDMA) from the recalled batches daily for four years, there may be one additional case of cancer over the lifetimes of those 8,000 people. In reality, the vast majority of patients exposed to NDMA through ARBs received much smaller amounts of the impurity than this worst-case scenario, and, since not all ARBs are affected, it’s very likely that a patient taking an ARB for four years would not have always received one of the affected products.”

FDA Releases Guidance on Cancer Clinical Trials – The FDA issued a final guidance titled “Placebos and Blinding in Randomized Controlled Cancer Clinical Trials for Drug and Biological Products Guidance for Industry.” The final guidance addresses recommendations “about the use of placebos and blinding in randomized controlled clinical trials in development programs for drug or biological products to treat hematologic malignancies and oncologic diseases. This guidance does not address the statistical analyses that can be considered when data are unblinded in these trials.”

Medical Devices

FDA Issues Recommendations to Duodenoscope Manufacturers – The FDA announced that it is recommending manufacturers of duodenoscopes move “away from using duodenoscopes with fixed endcaps to those with disposable components that include disposable endcaps—or to fully disposable duodenoscopes when they become available. Disposable designs simplify or eliminate the need for reprocessing, which may reduce between-patient duodenoscope contamination as compared to reusable, or fixed endcaps.”

FDA Publishes Two Guidance Documents on Medical Device Approvals – The FDA made available final guidance titled “Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications.” The guidance clarifies “for FDA reviewers and industry regarding the principal factors FDA considers when making benefit-risk determinations during the premarket review process for certain medical devices. FDA believes that the uniform application of the factors listed in this guidance document will improve the predictability, consistency, and transparency of the premarket review process.” The second guidance, titled “Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions,” addresses FDA’s “current approach to considering uncertainty in making benefit-risk determinations to support FDA premarket decisions for medical device premarket approval applications (PMAs), De Novo requests, and humanitarian device exemption (HDE) applications.”

Tobacco

FDA Announces Collaboration With States in E-cigarette Products – The FDA’s acting commissioner announced FDA’s collaboration with the CDC and state health officials to investigate vape-related health issues. The acting commissioner stated, “First, we are updating the number of potential cases of respiratory illnesses reported after use of e-cigarette products. Additionally, we are sharing more details about the work CDC and FDA are undertaking as part of the investigation, including its current status. We are also providing the public and our health partners across the country with information to help mitigate the risk of additional incidents and what health officials and clinicians can do to help us gather as much data as possible to better understand these illness and potential causes.”

Pharmacy

FDA Issues Notice Related to 503B Bulks List – The FDA published a notice of “nine bulk drug substances that FDA has considered and is proposing not to include on the [503B bulks] list.” The list includes dipyridamole, ephedrine sulfate, famotidine, hydralazine hydrochloride, methacholine chloride, sodium bicarbonate, sodium tetradecyl sulfate, trypan blue and vecuronium bromide.

DEA Provides Notice of Pending Marijuana Manufacturer Applications – The notice lists pending applications for those entities that have submitted applications to register as manufacturers of marijuana for research purposes.

Outsourcing Facility Issues Voluntary Recall – An outsourcing facility has agreed to a voluntary recall of all sterile drug products within expiry. The FDA stated, “The drugs — which include compounded ophthalmic products among other drug products — pose unnecessary risks due to significant quality and sterility concerns.”

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