Health Care

Food, Ag, & Trade Outlook in the Incoming Trump Administration

FDA, Agriculture & Agribusiness, Customs and Trade, Food Distribution & International Trade, For Export, Government Relations, Health Care, Healthcare, USDA, USTR / Ben Dash

The food, agriculture, and trade sectors are aware the Trump Administration could bring myriad policy changes that could have a significant impact on business. OFW Law provides an initial outlook at the new administration’s approach to food, agriculture, and trade, which will be influenced by individual cabinet and other executive branch appointments who will […]

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February Food and Agriculture Regulatory Recap

Agriculture & Agribusiness, FDA, Food Manufacturing, Processing, and Marketing, Health Care, Public Policy, USDA / Kyla S. Kaplan

OFW’s Food & Agriculture team regularly monitors announcements and policy issuances from FDA, USDA, and other agencies to keep our clients apprised of regulatory developments that may impact their business. Here are a few of the developments from February that we took note of. If you have any questions or would like more information, please

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Declaration of a National Emergency Extended; Important Beyond Protecting the Public from the Risks of COVID-19

FDA, Food Manufacturing, Processing, and Marketing, Government Relations, Health Care / Tish Eggleston Pahl and Kyla S. Kaplan

On February 23, 2022, the Administration published in the Federal Register a Notice of “Continuation of the National Emergency Concerning Coronavirus Disease 2019 (COVID-19) Pandemic” to extend the national emergency declaration from March 13, 2020. The 2020 Declaration was due to expire on March 1, 2022 and, with this Administrative Order, the national emergency continues,

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Federal Vaccine Mandates – Where Things Stand

Litigation, Government Relations, Health Care, Healthcare, Life Sciences, Public Policy / Elisa Bayoumi

Updated on December 7, 2021 All federal vaccine mandates stayed pending Court action On September 9, 2021, President Biden issued Executive Order 14042: Ensuring Adequate COVID Safety Protocols for Federal Contractors which mandated that employees of federal contractors be fully vaccinated for COVID-19, following recommendations of the Safer Federal Workforce Task Force. In early November 2021,

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6th Circuit Selected in Lottery to Hear Lawsuits against OSHA ETS Vaccine and Testing Mandate

Agriculture & Agribusiness, CPSC, EPA, FDA, Government Relations, Health Care, Healthcare, Life Sciences, Public Policy, USDA, USDA FSIS / Kyla S. Kaplan

On November 16, 2021, the Judicial Panel on Multidistrict Litigation, through a lottery system, drew the 6th Circuit as the U.S. Court of Appeals that will hear the consolidated lawsuits against the Occupational Health and Safety Administration (OSHA) Emergency Temporary Standard (ETS) published in the Federal Register on November 5, 2021. The OSHA ETS, which

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Biden to Nominate Dr. Robert Califf as FDA Commissioner

FDA, Government Relations, Health Care, Healthcare / Elisa Bayoumi

On Friday November 12, 2021, President Biden nominated former United States Food and Drug Administration (FDA) Commissioner Dr. Robert Califf, a cardiologist by training, to again be FDA Commissioner, replacing acting Commissioner Dr. Janet Woodcock. Califf, 70, was the FDA Commissioner for a year at the end of the Obama Administration. He garnered broad support

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UPDATE: Federal Contractor Vaccine Mandate

Agriculture & Agribusiness, FDA, Food Manufacturing, Processing, and Marketing, Government Relations, Health Care, Healthcare, USDA, USDA FSIS / Tish Eggleston Pahl and Kyla S. Kaplan

Federal Contractors are being given additional time and flexibility to address the vaccination mandate – Employees must be fully vaccinated by January 18, 2022. The Department of Health and Human Services (HHS) and The United States Department of Agriculture (USDA) Contracting Officers Have Enormous Discretion To Add Vaccine Mandate Clause to Product Contracts.

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OSHA Releases ETS on Vaccine and Testing Mandate

FDA, Government Relations, Health Care, Healthcare / Kyla S. Kaplan

On November 4, 2021, the Occupational Safety and Health Administration’s (OSHA) released the prepublished version of its expected new emergency temporary standard (ETS). The OSHA ETS (interim final rule; request for comments) was published in the Federal Register on November 5, 2021. The OSHA ETS requires employers with 100 or more employees to mandate that all their

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FDA Notice of Proposed Rulemaking: Proposed Repeal of HHS Rules on Guidance, Enforcement, and Adjudication Procedures

FDA, Health Care, Healthcare, Life Sciences / Kyla S. Kaplan

On October 20, the United States Department of Health and Human Services (HHS) published a Notice of Proposed Rulemaking that would, in relevant part, repeal a Trump Administration rule on, “Department of Health and Human Services Good Guidance Practices,” (GGP Rule) (Dec 7, 2020). The GGP Rule required: Each guidance document issued by HHS

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FDA Announces a DSCSA Public Meeting and Requests Comments

FDA, Health Care, Healthcare, Life Sciences / Tish Eggleston Pahl and Kyla S. Kaplan

The United States Food and Drug Administration (FDA) announced that it will be virtually hosting a public meeting on November 16, 2021, on Drug Supply Chain Security Act (DSCSA) implementation. The purpose of this meeting is to allow interested stakeholders the opportunity to provide input to the FDA on the enhanced drug distribution security provisions

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Xavier Becerra’s Nomination Hearing Set

Health Care, FDA / Reed Diskey

The Senate Committee on Health, Education, Labor and Pensions (HELP) announced that it will hold a hearing on Tuesday, February 23 to consider Xavier Becerra’s nomination to serve as Secretary of Health and Human Services (HHS). The Senate Finance Committee will hold a hearing on Wednesday, February 24. Becerra has served as Attorney General of California

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