Alerts

FDA and Pharmacy Weekly Digest - August 20

Alerts / August 20, 2019
Food/Dietary Supplements

FDA Remarks at National Industrial Hemp Council 2019 Hemp Business Summit – The Principal Associate Commissioner for Policy for the FDA stated, “We’ve seen rapidly growing interest in marketing hemp products in other FDA-regulated products, including human and animal foods, as well as dietary supplements and cosmetics … under current law, it’s unlawful to sell a food or dietary supplement with CBD in interstate commerce. I’ll repeat that: Under current law, it’s unlawful to sell a food or a dietary supplement with CBD in interstate commerce. At FDA, we recognize that there’s substantial interest in marketing or accessing CBD in these forms. And we’ve heard calls for FDA to allow CBD to be sold in foods or supplements based on another exception in the statute. … Given the substantial public interest in the possibility of CBD in foods and/or supplements, FDA is actively evaluating whether such rulemaking might be appropriate for CBD.”

FDA Releases Guidance on Units of Measure for Certain Nutrients – This final guidance “provides step-by-step instructions to manufacturers of retail food products marketed in the United States on how they may convert the previous units of measure for certain nutrients to the new units in the updated Nutrition Facts label (81 FR 33742 at 33906-33916 and § 101.9 (21 CFR 101.9)). This guidance document also provides conversion factors that can be used for each of these nutrients and example calculations for converting to the new units of measure for conventional foods and dietary supplements. Lastly, this guidance document provides information that can help manufacturers understand and comply with relevant labeling requirements.

Drugs/Biologics

FDA Issues Guidance on Clinical Evaluation of Drugs for Treatment of Gastroparesis – The FDA published this draft guidance to “assist sponsors in the clinical development of drugs for treating idiopathic and diabetic gastroparesis. Specifically, this guidance addresses FDA’s current recommendations regarding clinical trial designs and clinical endpoint assessments to support developing gastroparesis drugs.”

FDA Releases Child-Resistant Packaging Guidance – This final guidance will “assist applicants, manufacturers, packagers, and distributors (collectively referred to as firms) who choose to include child-resistant packaging (CRP) statements in their drug product labeling. The guidance discusses what information should be included to support CRP statements in labeling for new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologics license applications (BLAs), and supplements to these applications.”

FDA Publishes Guidance on Osteoporosis Treatments – This final guidance “provide[s] recommendations to industry for designing nonclinical bone quality studies to support the approval of drugs and biologics intended for the treatment of osteoporosis.”

FDA Issues Guidance on Vet Drugs in Food-Producing Species – This final guidance “provide[s] study design recommendations that will facilitate the universal acceptance of the generated residue depletion data to fulfill the national/regional requirements for drugs intended for using in aquatic food-producing species.”

Medical Devices

FDA Announces Upcoming Patient Engagement Advisory Committee Meeting – On Sept. 10, 2019, the FDA will hold a Patient Engagement Advisory Committee meeting. The Committee’s role is to “provide advice to the Commissioner, or designee, on complex issues relating to medical devices, the regulation of devices, and their use by patients.” The topic for this meeting is “Cybersecurity in Medical Devices: Communication That Empowers Patients.”

Tobacco

FDA Sees Results From Youth Smoking Prevention Efforts – The FDA announced that it is seeing successes resulting from the Real Cost campaign. The FDA cited the results of a study published by the American Journal of Preventive Medicine. The FDA stated, “The study, which builds on previous evaluations, shows that our award-winning campaign has prevented up to 587,000 youth nationwide from initiating smoking between the campaign’s launch in February 2014 and November 2016, half of whom might have gone on to become established smokers. Preventing youth from smoking is not only critical to each teen who does not become an addicted smoker, but these results are also enormously beneficial to public health.”

FDA Issues Proposed Rule on Tobacco Warnings – The FDA stated that the proposed rule will “require new health warnings on cigarette packages and in advertisements to promote greater public understanding of the negative health consequences of smoking. The proposed warnings, which feature photo-realistic color images depicting some of the lesser-known, but serious health risks of cigarette smoking, stand to represent the most significant change to cigarette labels in more than 35 years. When finalized, this rule would fulfill a requirement in the Family Smoking Prevention and Tobacco Control Act and complement additional important work the FDA is undertaking to advance the health of America’s families.” The comment period for the proposed rule is open through Oct. 15, 2019.

Pharmacy

Massachusetts Passes PBM Transparency Bill – The bill requires that PBMs managing benefits in the Medicaid program disclose certain pieces of information, including all sources and amounts of income, payments and financial benefits, related to the provision and administration of pharmacy benefit management services on behalf of the managed care provider.

New Hampshire Governor Signs PBM Transparency Bill – The bill requires PBM registration with the department of insurance, specific contract terms when PBMs contract with pharmacies, and annual reporting of rebates.

Authorship Credit: Lindsay P. Holmes

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