Health Care

February Food and Agriculture Regulatory Recap

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

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

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

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

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

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

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

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

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

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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5/15/20 OFW Law Daily COVID-19 News Conference Summary

President Donald Trump held a 45-minute press conference beginning at 12:40 this afternoon. He was joined by Secretary of Health and Human Services, Secretary of Defense Mark Esper, Dr. Moncef Slaoui, former head of GlaxoSmithKline’s vaccine division, named today as the Chief Scientist for Operation Warp Speed, and General Gustave Perna, commanding general of the …

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5/11/20 OFW Law Daily COVID-19 News Conference Summary

President Donald Trump held a 1-hour press conference beginning at 4:15 this afternoon. He was joined by Assistant Secretary for Health Admiral Brett Giroir, M.D., and the Director of the Center for Medicare and Medicaid Services Brad Smith. Summary of the President’s remarks and questions: The President said the purpose of today’s press conference was …

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4/27/20 OFW Law Daily COVID-19 News Conference Summary

President Donald Trump and the Vice President held a 1-hour press conference beginning at 5:40 this evening. They were joined White House Coronavirus Response Coordinator Deborah Birx, and Assistant Secretary for Health Admiral Brett Giroir, M.D. Summary of the President’s remarks and questions: The President said the number of new cases continues to decline with …

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4/24/20 OFW Law Daily COVID-19 News Conference Summary

President Donald Trump and the Vice President held a less than 25-minute press conference beginning at 5:40 this evening. Neither the President nor the Vice President took any questions. They were joined by FDA Commissioner Stephen Hahn. Summary of the President’s remarks: The President said the aggressive strategy is still working. New cases in New …

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4/23/20 OFW Law Daily COVID-19 News Conference Summary

President Donald Trump and the Vice President held a 1-hour press conference beginning at 5:48 this evening. They were joined by Acting Department of Homeland Security Under Secretary William N. Bryan, and White House Coronavirus Response Coordinator Deborah Birx. Summary of the President’s remarks and questions: The President said that in 23 states new cases …

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4/22/20 OFW Law Daily COVID-19 News Conference Summary

President Donald Trump and the Vice President held a 1-hour and 40-minute press conference beginning at 5:47 this evening. They were joined by Centers for Disease Control Director Robert Redfield, MD, White House Coronavirus Response Coordinator Deborah Birx, Infectious Diseases Director Dr. Anthony Fauci, and Surgeon General of the United States Vice Admiral Jerome Adams …

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4/21/20 OFW Law Daily COVID-19 News Conference Summary

President Donald Trump held a 1-hour and 10-minute press conference beginning at 5:47 this evening. He was joined by Treasury Secretary Steven Mnuchin, White House Coronavirus Response Coordinator Deborah Birx, and FDA Commissioner Stephen Hahn. Summary of the President’s remarks and questions: The President opened with saying that 20 states have announced that they are …

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4/20/20 OFW Law Daily COVID-19 News Conference Summary

President Donald Trump and Vice President Pence held a nearly 1-hour and 40-minute press conference beginning at about 5:40 this evening. They were joined by Commanding General of the Army Corps of Engineers Lt. General Todd Semonite, Assistant Secretary for Health Admiral Brett Giroir, M.D., the Director of the Center for Medicare and Medicaid Services …

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4/19/20 OFW Law Daily COVID-19 News Conference Summary

President Donald Trump and Vice President Pence held a nearly 1-hour and 30-minute press conference beginning at about 6:27 this evening. They were joined by Administrator for the Centers for Medicare and Medicaid Seema Verma, and FDA Commissioner Stephen Hahn. Summary of the President’s remarks and questions: The President said they are continuing to negotiate …

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4/18/20 OFW Law Daily COVID-19 News Conference Summary

President Donald Trump held a 1-hour and 10-minute press conference beginning at about 5:09 this evening. He was joined by White House Coronavirus Response Coordinator Deborah Birx. Summary of the President’s remarks and questions: The President said there are a number of positive signs that the virus is past its peak. He said the US …

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4/17/20 OFW Law Daily COVID-19 News Conference Summary

President Donald Trump and Vice President Pence held a 2-hour press conference beginning at about 6:21 yesterday evening. They were joined by Secretary of Agriculture Sonny Perdue, Infectious Diseases Director Dr. Anthony Fauci, White House Coronavirus Response Coordinator Deborah Birx, Centers for Disease Control Director Robert Redfield, MD, and Assistant Secretary for Health Admiral Brett …

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4/16/20 OFW Law Daily COVID-19 News Conference Summary

President Donald Trump and Vice President Pence held a 1-hour and 15-minute press conference beginning at about 6:05 this evening. They were joined by White House Coronavirus Response Coordinator Deborah Birx, Infectious Diseases Director Dr. Anthony Fauci, and Centers for Disease Control Director Robert Redfield, MD. Summary of the President’s remarks and questions: The President …

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4/15/20 OFW Law Daily COVID-19 News Conference Summary

President Donald Trump and Vice President Pence held a one-hour press conference beginning at about 5:48 yesterday evening. They were joined by White House Coronavirus Response Coordinator Deborah Birx, and Secretary of Agriculture Sonny Perdue. Summary of the President’s remarks and questions: The President said the aggressive strategy we are following is working. He said …

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4/14/20 OFW Law Daily COVID-19 News Conference Summary

President Donald Trump press conference that was slightly longer than one hour beginning at about 6:14 this evening. He was the only one speaking and taking questions tonight. Summary of the President’s remarks and questions: The President announced that he is halting the funding of the World Health Organization (WHO) while a review is conducted …

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4/13/20 OFW Law Daily COVID-19 News Conference Summary

President Donald Trump and Vice President Pence held a nearly 2-hour and 25-minute press conference beginning at about 5:47 this evening. The President left after about 1 hour and 45 minutes.  They were joined by Secretary of the Treasury Steven Mnuchin, Infectious Diseases Director Dr. Anthony Fauci, White House Coronavirus Response Coordinator Deborah Birx, FDA …

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4/10/20 OFW Law Daily COVID-19 News Conference Summary

President Donald Trump and Vice President Pence held a 2-hour and 15-minute press conference beginning at about 1:52 this afternoon. They were joined by Infectious Diseases Director Dr. Anthony Fauci, White House Coronavirus Response Coordinator Deborah Birx, FDA Commissioner Stephen Hahn, and Surgeon General of the United States Vice Admiral Jerome Adams. Summary of the …

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4/9/20 OFW Law Daily COVID-19 News Conference Summary

President Donald Trump and Vice President Pence held a 1-hour press conference beginning at about 6:25 this evening. The President left after 30 minutes.  They were joined by White House Coronavirus Response Coordinator Deborah Birx, Infectious Diseases Director Dr. Anthony Fauci, and Secretary of Labor Eugene Scalia. Summary of the President’s remarks and questions: The …

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4/8/20 OFW Law Daily COVID-19 News Conference Summary

President Donald Trump and Vice President Pence held a nearly 1-hour and 45-minute press conference beginning at about 5:48 pm yesterday. The President left after nearly 1 hour.  They were joined by Secretary of State Mike Pompeo, White House Coronavirus Response Coordinator Deborah Birx, Infectious Diseases Director Dr. Anthony Fauci, and Centers for Disease Control …

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4/7/20 OFW Law Daily COVID-19 News Conference Summary

President Donald Trump and Vice President Pence held a nearly 1-hour and 45-minute press conference beginning at about 5:45 this evening. The President left after nearly 1 hour.  They were joined by Infectious Diseases Director Dr. Anthony Fauci, Administrator for the Centers for Medicare and Medicaid Seema Verma, and White House Coronavirus Response Coordinator Deborah …

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4/6/20 OFW Law Daily COVID-19 News Conference Summary

President Donald Trump and Vice President Pence held a nearly 2-hour and 15-minute press conference beginning at about 5:42 this evening. The President left after 1 hour and 40 minutes.  They were joined by Infectious Diseases Director Dr. Anthony Fauci, Assistant Secretary for Health Admiral Brett Giroir, M.D., and White House Coronavirus Response Coordinator Deborah …

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4/5/20 OFW Law Daily COVID-19 News Conference Summary

President Donald Trump and Vice President Pence held a nearly 90-minute press conference beginning at about 7:00 this evening. They were joined by White House Coronavirus Response Coordinator Deborah Birx, FEMA Supply Chain Task Force Leader Rear Admiral John Polowczyk, Secretary of Veterans Affairs Robert Wilkie, and National Institute of Allergy and Infectious Diseases Director …

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4/4/20 OFW Law Daily COVID-19 News Conference Summary

President Donald Trump and Vice President Pence held a 1 hour and 45-minute press conference beginning at about 4:15 this evening. They were joined by FDA Commissioner Stephen Hahn, White House Coronavirus Response Coordinator Deborah Birx, and National Institute of Allergy and Infectious Diseases Director Dr. Anthony Fauci. Summary of the President’s remarks and questions: …

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4/3/20 OFW Law Daily COVID-19 News Conference Summary

President Donald Trump held a 90-minute press conference beginning at about 5:20 this evening. He was joined by House Minority Leader Kevin McCarthy (R-CA), White House Coronavirus Response Coordinator Deborah Birx, HHS Secretary Alex Azar, Surgeon General of the United States Vice Admiral Jerome Adams, and Centers for Disease Control Director Robert Redfield, MD. Summary …

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4/2/20 OFW Law Daily COVID-19 News Conference Summary

President Donald Trump held a more than 2-hour press conference beginning at about 5:20 Thursday evening. It was broken into two segments. In the first segment the President was joined by Small Business Administration Administrator Jovita Carranza and Secretary of the Treasury Steven Mnuchin.  In the second segment he was joined by Vice President Pence, …

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4/1/20 OFW Law Daily COVID-19 News Conference Summary

President Donald Trump held a nearly 2-hour press conference beginning at about 5:35 this evening. It was broken into two segments.  The first included Secretary of Defense Mark Esper, Chairman of the Joint Chiefs, Gen. Mark Milley, Attorney General William Barr, National Security Advisor Robert O’Brien, and Chief of Naval Operations Admiral Michael Gilday.  In …

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