News & Analysis as of

Manufacturers Vaccinations

King & Spalding

Major Shift in Best Price Proposed in Grab Bag of MDRP Reforms

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The title of CMS’s May 26 proposed rule, “Misclassification of Drugs, Program Administration and Program Integrity Updates Under the MDRP,” buries the lede. Amid twenty Medicaid Drug Rebate Program-related proposals—some...more

Jackson Lewis P.C.

2022: The Year Ahead for Employers

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In 2021, the workforce continued adapting to an evolving global pandemic, increasingly consequential social movements and a dramatic shift in employment policy ushered in by a change of leadership at the federal level. ...more

Fisher Phillips

Snapshot on Manufacturing Industry: February 2022

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Welcome to FP Snapshot on Manufacturing Industry, where we take a quick snapshot look at the most significant workplace law developments over the past month with an emphasis on how they impact manufacturers. OSHA Penalties...more

Alston & Bird

FDA Extends Pause on Non-mission-critical Domestic Surveillance inspections to February 4 – Medical Products Supply Chain Week in...

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In this week’s issue, OSHA withdrew its emergency temporary standard (ETS), which required a mandatory vaccination policy for large private employers with an exception for employers that adopt a policy requiring mandatory...more

Robinson+Cole Manufacturing Law Blog

2022 Labor and Employment Outlook for Manufacturers

This week, we continue our 2022 outlook series with a focus on labor and employment.  It goes without saying that over the last two years, the COVID-19 pandemic has revealed certain weaknesses and opportunities in the economy...more

Alston & Bird

FDA Suspends Non-Mission-Critical Domestic and Foreign Inspections – Medical Products Supply Chain Week in Review

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Just before the New Year holiday, the FDA announced it that was suspending non-mission-critical domestic and foreign inspection activities. The FDA amended the EUA of the Moderna COVID-19 vaccine booster. The Center for Drug...more

Robinson+Cole Manufacturing Law Blog

Supreme Court Halts Implementation of OSHA ETS

We take a break from our regularly scheduled “2022 outlook” programming to bring you breaking news on the seesaw that is the enforcement of OSHA’s Emergency Temporary Standard (ETS) regarding COVID-19 vaccination or testing....more

Alston & Bird

FDA Authorizes Booster Dose for Adolescents – Medical Products Supply Chain Week in Review

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Over the holidays, the CDC updated its recommendations for post-exposure quarantining and masking. The FDA authorized the Pfizer vaccine booster dose for adolescents 12–15 years of age and for immunocompromised children 5–11...more

Robinson+Cole Manufacturing Law Blog

Supreme Court to Hear Arguments on Two Federal Vaccine Mandates

On December 21, 2021, the U.S. Supreme Court took its first step into the fray over federal vaccine mandates. As we have previously posted, legal challenges to the Biden administration’s various vaccine mandates have been...more

Robinson+Cole Manufacturing Law Blog

A Tale of Two COVID-19 Vaccine Mandates

Over the last few months, manufacturers have been paying close attention to two COVID-19 vaccination mandates issued by the federal government pertaining to employers.  First, on September 9, 2021, President Biden issued an...more

Faegre Drinker Biddle & Reath LLP

Going Paperless: What Manufacturers Need to Know Before Digitizing Warnings

By the time the COVID-19 pandemic began, society was well into the so-called “Digital Age,” relying heavily on electronic communications, apps, websites, and the like to go about daily activities. Everything from ordering...more

Alston & Bird

Medical Products Supply Chain Week in Review – November 2021 #2

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In the past week, the President has selected Dr. Robert Califf to be FDA commissioner. Congress passed the Infrastructure Investment and Jobs Act. New vaccination requirements were issued by OSHA and CMS for certain...more

Alston & Bird

Medical Products Supply Chain Week in Review – November 2021 #1

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In the past week, the FDA granted an EUA for the Pfizer-BioNTech vaccine for use in children 5–11 years of age. The agency also participated in the launch of the Bespoke Gene Therapy Consortium. The Administration held a...more

Searcy Denney Scarola Barnhart & Shipley

Is Rapid Really a Good Thing? — FDA-Approved Over-the-Counter COVID-19 Test Recalled

Over 400,000 COVID-19 rapid test kits have been recalled by Australian manufacturer Ellume. The reason? Way too many false positive results. “At Ellume, we understand that trust is central to fulfilling our purpose...more

Polsinelli

During a Global Health Crisis, IP Rights Are Getting a Bad Rap

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Four months ago, the U.S. became one of 100 countries supporting the proposal presented a year ago to the World Trade Organization (WTO) by India and South Africa that intellectual property protection for COVID-19 vaccines be...more

Alston & Bird

Medical Products Supply Chain Week in Review – October 2021 #1

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Last week, AstraZeneca and Merck filed emergency use authorization (EUA) requests for their COVID-19 drugs. The FDA provided information to the public about a database repository of gene variants and associated conditions....more

Jackson Lewis P.C.

Practical Strategies for Manufacturers Managing COVID-19 Testing, Vaccine Mandates

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Manufacturing employers continue to feel the brunt of emerging and evolving trends related to the COVID-19 pandemic: workplace safety, labor shortages, absence management, remote technology, and employee retention — just to...more

Robinson+Cole Manufacturing Law Blog

Mandatory Vaccination and Safety Protocols for Federal Contractors

Last month, President Biden issued an Executive Order which effectively imposes several COVID-19 safety standards and protocols, including mandatory vaccination, upon certain federal contractors and subcontractors....more

Alston & Bird

Medical Products Supply Chain Week in Review – September 2021 #3

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Last week, the White House COVID-19 Response Team indicated the Administration is ready to begin providing booster vaccine doses to eligible Americans. The FDA alerted clinical laboratory staff and health care professionals...more

Pullman & Comley, LLC

Manufacturing Updates - Fall 2021

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Welcome to Manufacturing Updates, Pullman & Comley’s quarterly publication that summarizes important legal developments for manufacturers. Manufacturing Updates brings together insights from attorneys across our many practice...more

Alston & Bird

Medical Products Supply Chain Week in Review – September 2021 #1

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Over the last two weeks, the President signed Executive Orders requiring all federal employees and contractors to be vaccinated. The White House COVID-19 Response Team announced a $3 billion investment in the vaccine supply...more

Robinson+Cole Manufacturing Law Blog

Navigating Requests for Exemption from Mandatory Workplace Vaccination Policies

While employers in healthcare and education have mandated, or considered mandating, vaccination of employees during the COVID-19 pandemic, recently employers in many other industries are considering doing so....more

Alston & Bird

Medical Products Supply Chain Week in Review – August 2021 #5

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Last week, the White House COVID-19 Response Team encouraged school systems to implement a layered approach to prevention as schools return to in-person learning. Moderna submitted a Biologics License Application (BLA) for...more

Alston & Bird

Medical Products Supply Chain Week in Review – August 2021 #4

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Last week, Roche announced a shortage of its drug Actmera/RoActmera, which is used to treat COVID-19. The company, however, does have a mitigation strategy that it plans to implement to lessen the impact. The White House...more

Alston & Bird

Medical Products Supply Chain Week in Review – August 2021 #3

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Last week, the FDA amended the Moderna and Pfizer-BioNTech emergency use authorizations (EUAs) to allow an additional dose of the mRNA COVID-19 vaccine for immunocompromised individuals. In addition, the Secretaries of...more

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