Food/Dietary Supplements

FDA Releases Menu Labeling Social Media Toolkit – The Food and Drug Administration (FDA) made a “menu labeling social media toolkit.” According to the FDA, “This toolkit is designed to raise awareness of how consumers can use calorie information they may now see on menus and menu boards. It features web badges that can be embedded in an organization’s website, a sample newsletter/blog that can be adapted and posted, and social media messages for sharing on Facebook and Twitter.”

FDA Issues Health Alert About French Soft Cheese – The FDA published a public health alert to warn consumers about potential Listeria monocytogenes in certain soft, ripened cheese.

FDA Conducts Investigation of Illness Related to Raw Oysters – The FDA alerted consumers about potential Shigella illnesses related to consumption of raw oysters. The FDA warned that “[c]onsumers should not purchase oysters marketed as being harvested from Estero El Cardon, in Baja California Sur, Mexico, from restaurants.”

Drugs/Biologics

FDA Approves Novel Gene Therapy – The FDA announces the approval of “the first gene therapy approved to treat children less than two years of age with spinal muscular atrophy (SMA), the most severe form of SMA and a leading genetic cause of infant mortality.”

FDA Reiterates Priority of OTC Products – The chief of staff to the office of the commissioner made remarks at the Consumer Health Products Association Regulatory, Scientific, and Quality Conference. During the conference, Ms. Silvis stated, “On the monograph side, I want to make clear today that OTC monograph reform remains a top priority for the agency.”

Medical Devices

FDA Alerts Providers About Recall of Blood Test Analyzers – The FDA issued a health alert to hospitals, laboratories and providers about a Class 1 recall of hematology analyzers because “the company received complaints of inaccurate blood platelet counts.”

FDA Announces First Zika Diagnostic Test – The FDA authorized the marketing of the first “diagnostic test to detect Zika virus immunoglobulin (IgM) antibodies in human blood.”

Tobacco

​FDA Seeks Manufacturers to Participate in Site Tours – FDA issued a notice inviting entities to participate in its Electronic Nicotine Delivery System (ENDS) Device and E-Liquid Manufacturer Site Tours Program. The notice states, “This program is intended to give CTP staff an opportunity to visit facilities that develop, manufacture, or test ENDS devices or e-liquids (including pods or cartridges) to gain a better understanding of the processes involved in the development, manufacturing, and testing of ENDS devices and e-liquids. The site tours in this program are not intended as regulatory inspections. The purpose of this document is to invite ENDS device or e-liquid manufacturers that can demonstrate assembly process and present supply chain information, and laboratories that conduct ENDS aerosol and e-liquid testing, that are interested in participating in the ENDS Device and E-Liquid Manufacturer Site Tours Program to submit requests to CTP.”

Pharmacy

Federal Court Enters Consent Decree Against Texas Outsourcing Facility – A Texas federal judge entered a consent decree for a permanent injunction against a Texas-based outsourcing facility. The facility has been ordered to stop manufacturing and distributing sterile drug products until specific corrective actions are completed.

Federal Court Enters Consent Decree Against Illinois-based Outsourcing Facility – A U.S. District Court entered a consent decree for a permanent injunction against an Illinois-headquartered outsourcing facility. According to the FDA, “The consent decree prohibits PharMedium and the other defendants from, among other things, manufacturing, holding, or distributing PharMedium’s drugs at or from its Tennessee facility until it completes corrective actions and receives authorization from the FDA. The company has ceased operations at its Mississippi facility, and its Texas and New Jersey facilities must, among other things, hire an independent expert to review PharMedium’s operations at these facilities to ensure compliance with the law.”

CMS Issues Memo to Part D Plan Sponsors on the Bid Process – A Centers for Medicare & Medicaid Services (CMS) memo titled “Additional Guidance Regarding Part D Bids” responds to a number of questions to clarify CMS’s guidance addressing bids for CY2020.

Oklahoma Passes Pharmacy Choice Law – The Oklahoma Legislature passed HB 2632, which prohibits pharmacy benefit managers from requiring “patients to use pharmacies that are directly or indirectly owned by the pharmacy benefits manager, including all regular prescriptions, refills or specialty drugs regardless of day supply.”