Alerts

FDA and Pharmacy Weekly Digest - March 25

Alerts / March 25, 2019
Food/Dietary Supplements

FDA Announces Plans to Strengthen Food Safety Program – The FDA proposed new funding under the 2020 budget to address multiple areas of the food safety system. The release states, “The funds we’re requesting for food safety represent the FDA’s commitment to the promises we’ve made to help keep people and animals safe from contaminated food, and our vision of a future in which both human and animal health is protected and strengthened by new and emerging technologies that will create a more digital, traceable, diverse, and safer food system.”

FDA Issues Draft Guidance Addressing Intentional Adulteration – The FDA released a revised draft guidance titled “Mitigation Strategies to Protect Food Against Intentional Adulteration: Guidance for Industry.” The guidance focuses on “intentional adulteration in the context of facilities that manufacture, process, pack, or hold food, and that are required to register under section 415 (21 U.S.C. 350d).”

FDA Releases Guidance on Labeling of Foods Derived From Genetically Engineered Plants – The FDA issued a guidance titled “Voluntary Labeling Indicating Whether Foods Have or Have Not Been Derived from Genetically Engineered Plants.” The guidance focuses on “the voluntary labeling of plant-derived foods with information concerning whether the food was or was not produced using genetic engineering.”

Drugs/Biologics

FDA Takes Action Against Homeopathic Pain Products – The FDA released a press announcement stating that health fraud scams, such as certain homeopathic products claiming to treat pain, without FDA approval, pose serious health risks to consumers. The FDA coupled this announcement with a warning letter issued to a company for “illegally marketing unapproved products labeled as homeopathic with claims about their ability to treat addiction and chronic pain, including pain associated with cancer, diabetes, shingles, fibromyalgia and other serious conditions.”

First Postpartum Depression Treatment Gains FDA Approval – The FDA announced its approval of the first treatment for postpartum depression. The application was granted priority review and a breakthrough therapy designation.

FDA Issues Two Guidance Documents for HIV Drug Development – The FDA released a guidance titled “Pediatric HIV Infection: Drug Product Development for Treatment.” The guidance is intended to “provide general recommendations on the development of antiretroviral (ARV) drug products for the treatment of human immunodeficiency virus (HIV) infection in pediatric (birth to younger than 18 years of age) patients.” It also released a guidance titled “Human Immunodeficiency Virus-1 Infection: Developing Systemic Drug Products for Pre-Exposure Prophylaxis.” This guidance is intended to “provide to sponsors nonclinical and clinical recommendations specific to the development of systemic drug products, with a focus on long-acting systemic drug products (including small molecules and monoclonal antibodies), regulated within the Center for Drug Evaluation and Research at the Food and Drug Administration (FDA) for the prevention of sexually acquired human immunodeficiency virus-1 (HIV-1) infection.”

FDA Releases Guidance on Drug Development for Rare Diseases – The FDA issued a guidance titled “Rare Diseases: Natural History Studies for Drug Development.” The purpose of this guidance is “to help inform the design and implementation of natural history studies that can be used to support the development of safe and effective drugs and biological products for rare diseases.”

Medical Devices

FDA Sends Warning Letter to Breast Implant Manufacturers – The FDA issued warning letters to two manufacturers of breast implants for failing to conduct studies to determine the long-term safety of silicone gel-filled breast implants.

Device to Treat Chronic Heart Failure Gains FDA Approval – The FDA announced the approval of a device to treat moderate to severe chronic heart failure. The announcement states that the device was given “a Breakthrough Device designation because it treats a life-threatening disease, heart failure, and addresses an unmet medical need in patients who fail to get adequate benefits from standard treatments and have no alternative treatment options.”

Tobacco

FDA Issues Guidance to Vape Shops – The FDA issued a guidance titled “Interpretation of and Compliance Policy for Certain Label Requirement; Applicability of Certain Federal Food, Drug, and Cosmetic Act Requirements to Vape Shops.” This guidance “is intended to assist retailers who sell newly deemed products by explaining whether engaging in certain activities subjects such establishments to additional requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and identifying the limited circumstances under which FDA does not intend to enforce compliance."

Pharmacy

Maryland to Hold Hearings on Two Drug Pricing Bills – The Maryland Senate is set to hold hearings on two bills aimed at drug pricing. One bill would permit “a pharmacist or a pharmacy to decline to dispense a prescription drug or provide a pharmacy service to a certain member if the amount reimbursed by a certain insurer, nonprofit health service plan, or health maintenance organization is less than the pharmacy acquisition cost for the same prescription drug or pharmacy service.” The other would require “the Maryland Medical Assistance Program to enter into a contract with an independent auditor as soon as practicable to conduct an audit of certain pharmacy benefits managers for the purpose of determining the amount of Medicaid funds used to reimburse managed care organization, pharmacy benefits managers, and pharmacies and the dollar amount of funds received by each respective party."

Authorship Credit: Lindsay P. Holmes

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