United States: FDA And Pharmacy Weekly Digest - July 23

Food/Dietary Supplements

FDA Announces Consent Decree Against Food Warehouse – A U.S. District Court in Arkansas entered a consent decree against a facility that warehoused food, drug products and medical products under unsanitary conditions. The FDA’s press release states, “The consent decree of condemnation and permanent injunction … requires J and L Grocery to cease distribution of FDA-regulated products until it completes corrective actions. Under the consent decree, J and L Grocery may not resume operations until it establishes and implements a comprehensive written sanitation control program and receives written authorization from the FDA that it appears to be in compliance with the FD&C Act, among other requirements. As part of the consent decree, the company agreed to destroy the seized products.”

Drugs/Biologics

FDA Speaks on Efforts to Curb Spread of Illicit Fentanyl – The director of the Office of Enforcement and Import Operations (OEIO) within the FDA’s Office of Regulatory Affairs (ORA) spoke before the House Committee on Energy and Commerce’s Subcommittee on Oversight and Investigations about the opioid crisis. The director stated, “We must continue to be vigilant in our efforts to identify and stop unlawful drugs like illicit fentanyl from entering the United States, and as such, I am pleased to be here today to discuss the work we are doing at our nation’s borders and at the International Mail Facilities (IMF).”

FDA Issues Guidance on eCTD Submissions – The FDA published a draft guidance titled “Providing Regulatory Submissions in Electronic Format – Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications Guidance for Industry.” The draft outlines “how sponsors and applicants must organize the content that they submit to the Agency electronically for all submission types under section 745A(a) of the FD&C Act. This guidance also references several technical specification documents and the Electronic Common Technical Document Conformance (eCTD) Guide, which provide additional details regarding the organization of content for electronic submissions.”

FDA Announced a Draft Guidance on Advanced Prostate Cancer Treatment – The FDA released a guidance titled “Advanced Prostate Cancer: Developing Gonadotropin-Releasing Hormone Analogues Guidance for Industry.” The guidance sets out the FDA’s “current recommendations regarding the overall development program to establish the effectiveness and safety of gonadotropin-releasing hormone (GnRH) analogues for treating advanced prostate cancer.”

FDA Publishes Final Guidance on Next-Generation Sequencing Data – The FDA issued a final guidance titled “Submitting Next Generation Sequencing Data to the Division of Antiviral Products Guidance for Industry Technical Specifications Document.” The guidance sets out the FDA’s “current thinking of FDA’s Division of Antiviral Products (the Division) in regard to the submission of next generation nucleotide sequence analysis procedures and data in support of resistance assessments for the development of antiviral drug products.”

Medical Devices

FDA Issues Guidance on Postmarketing Safety Reporting – The FDA released a final guidance titled “Postmarketing Safety Reporting for Combination Products.” The guidance “addresses how to comply with the final rule on postmarketing safety reporting (PMSR) requirements for combination products that FDA issued on December 20, 2016. … The rule describes how to comply with PMSR requirements for combination products that have received FDA marketing authorization.”

Tobacco

FDA Releases E-Cig Prevention Ads – The FDA announced the launch of TV ads aimed at preventing youth e-cigarette use. The FDA also announced a print campaign to be introduced in high schools and middle schools throughout the U.S.

Pharmacy

Ohio Legislature Passes Hemp/CBD Bill – The Ohio legislature passed a bill that established a hemp marketing program and licensure for hemp cultivation and hemp processing. The legislation is awaiting the governor’s signature.

Canada Expresses Concerns About U.S. Drug Import Plans – Reuters reports that Canada “opposes any U.S. plans to buy Canadian prescription drugs that might threaten the country’s drug supply or raise costs for its own citizens.”

Oregon Legislature Passes PBM Bill – The bill prohibits a pharmacy benefit manager from requiring that a prescription be filled or refilled by a mail-order pharmacy as a condition of payment and retroactively denying or reducing a claim for reimbursement after adjudication except for specific reasons.

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