United States: FDA And Pharmacy Weekly Digest - June 11

Food/Dietary Supplements

FDA Issues Produce Draft Guidance – The FDA published a draft guidance titled “Evaluating Alternate Curricula for the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption.” The guidance outlines “recommendations on the factors that covered farms should consider if they are selecting an alternate curriculum training to meet the requirements of 21 CFR 112.22(c), and that educators should consider when developing or evaluating alternate curricula.”

FDA Warns of Dietary Supplements With Vinpocetine – The FDA issued a press announcement warning females of childbearing age about safety concerns with the ingredient vinpocetine in dietary supplements. FDA stated that “consumption of vinpocetine is associated with adverse reproductive effects – in other words, vinpocetine may cause a miscarriage or harm fetal development.”

Deputy Commissioner of Food Policy and Response Remarks on World Food Safety Day – The Deputy Commissioner stated, “Taking a world view of food safety is important for all consumers because food moves globally, as do we. In the U.S., about 15 percent of the food supply is imported from more than 200 countries or territories, including 32 percent of the fresh vegetables, 55 percent of the fresh fruit and at least 94 percent of the seafood that Americans eat each year. And these statistics are not unique to the U.S. – similar patterns are seen around the world and global movement of foods continues to grow. The FDA fully supports this united effort to advance the prevention, detection and mitigation of foodborne risks. But this is not something we can do just one day a year; our mission is one that must be carried out every day, anywhere where food is produced, 365 days a year.”

Associate Commissioner for Diplomacy and Partnerships Addresses the American Food Safety and Quality 2019 Conference – The Associate Commissioner stated, “Food safety does not enjoy a high profile within the global policy dialogue. It competes with many important public health challenges, such as maternal/child health, HIV/AIDS, TB and malaria, and the increasing incidence of noncommunicable diseases, to name only a few. And yet, per the WHO, one in 10 people fall ill every year from eating contaminated food and 420,000 die as a result. Children under 5 years are of high risk, with 125,000 children dying from foodborne diseases annually. Our goal is to bring food safety more central to national and global public health policy discussions.”

Drugs/Biologics

FDA Announces Project Facilitate – The FDA released information about its new pilot program “to assist oncology health care professionals in requesting access to unapproved therapies for patients with cancer.” The FDA indicated that “Project Facilitate will be a single point of contact where FDA oncology staff will help physicians treating patients with cancer through the process to submit an Expanded Access request for an individual patient, including follow-up of patient outcomes.”

Federal Court Releases Decision on Stem Cell Products – The FDA announced that a judge in the Southern District of Florida granted a summary judgment motion in favor of the government in a case alleging that several stem cell clinics “adulterated and misbranded a stem cell drug product made from a patient’s adipose tissue.”

FDA Publishes Draft Guidance on Clinical Trial Diversity – The FDA released a draft guidance titled “Enhancing the Diversity of Clinical Trial Populations – Eligibility Criteria, Enrollment Practices, and Trial Designs.” The guidance addresses “(1) broadening eligibility criteria and avoiding unnecessary exclusions for clinical trials; (2) developing eligibility criteria and improving trial recruitment so that the participants enrolled in trials will better reflect the population most likely to use the drug, if the drug is approved, while maintaining safety and effectiveness standards; and (3) applying the recommendations for broadening eligibility criteria to clinical trials for drugs intended to treat rare diseases or conditions.”

Medical Devices

FDA and FTC Coordinate to Take Action Against E-Liquid Companies – The agencies announced that they jointly issued warning letters to four e-liquid companies for social media posts because the social media posts do not contain the required nicotine warning statement.

Pharmacy

New York Legislature Investigates PBMs – The New York State Senate released a Final Investigation Report describing its investigation of pharmacy benefit managers (PBMs) in New York. The Senate committee issuing the report encouraged the “Legislature to take action by (1) regulating the practices of spread pricing in all pharmacy benefit contracts, (2) increasing the transparency of MAC appeals, (3) requiring the licensing and registration of PBMs operating in New York to enhance accountability and oversight, (4) prohibiting PBMs from mandating that patients use specialty and mail-order pharmacies, (5) providing for the adequate and transparent reimbursements for pharmacies and (6) requiring PBMs to pass-through all discounts or rebates received from drug manufacturers to its Medicaid managed care clients. Most importantly, this Committee urges the New York State Comptroller to perform a full audit of New York’s Medicaid managed care programs to understand the full effect PBMs – and spread pricing – has had on New York’s consumers. A comprehensive audit of state Medicaid managed care dollars is urgently necessary.”

Louisiana Governor Signs a Number of Pharmacy Bills – Louisiana enacted a number of restrictions on PBMs, including prohibitions on spread pricing, hidden fees, pharmacy contract cancellation for refusal to dispense products that will be reimbursed at less than the acquisition cost, and certain auditing practices.

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