Legally Qualified: Can Employers Require Vaccines?
Can Employers Require COVID-19 Vaccinations?
On July 6, the U.S. Food and Drug Administration (FDA) revised its emergency use authorization (EUA) for the COVID-19 antiviral treatment PaxlovidTM (nirmatrelvir and ritonavir) to allow prescribing by pharmacists for quicker...more
The U.S. Food and Drug Administration's ("FDA") approval of the Pfizer vaccine under a new brand name, Comirnaty, created a cascade of legal and regulatory issues for prescribers, pharmacies, and other vaccine administrators....more
On July 19, 2021, the U.S. Department of Health & Human Services (HHS) issued a Renewal of Determination that a Public Health Emergency Exists extending the federal COVID-19 public health emergency (PHE) for another ninety...more
The Biden administration has called for all people at least 18 to be eligible for the COVID-19 vaccine by April 19, 2021. Most states have already done so. A BenefitsPro article cites a 2017 survey from the Society for...more
The Public Readiness and Emergency Preparedness Act (PREP Act), 42 U.S.C. 247d-6d, provides liability immunity related to the manufacture, testing, development, distribution, administration and use of medical countermeasures...more
With COVID-19 vaccines now being distributed to healthcare facilities, including hospitals, long-term care, and other healthcare providers, employers in these industries are faced with an immediate decision: whether to...more
Why It Matters - Businesses should begin to address these issues now so that when COVID-19 vaccines are ready for distribution, they will be too....more
As the COVID-19 pandemic continues, and with an incoming Biden administration that is expected to step up efforts to control the spread of the virus, use of personal protective equipment (“PPE”) and cleaning/disinfectant...more
As the world awaits a successful COVID-19 vaccine, employers are beginning to consider the implications a new vaccine will have on their workplaces. Although much remains speculative, employers can look to the regulation of...more
The FDA recently reissued an Emergency Use Authorization (“EUA”) for the sale and import of certain non-NIOSH-approved respirators manufactured in China and used by healthcare personnel in the United States but, critically,...more
The FDA announced on October 7 that it will no longer review requests for Emergency Use Authorizations (EUAs) for COVID-19 laboratory developed tests – so called “LDTs.” This is a substantial change in Agency policy. From...more
The Food and Drug Administration released guidance for the use of convalescent plasma to treat COVID-19 to supplement its recently issued emergency use authorization. Our Food, Drug & Device/FDA Team analyzes the specifics of...more
On August 20, 2020, the Department of Health & Human Services (HHS) released a statement, Rescission of Guidances and Other Informal Issuances Concerning Premarket Review of Laboratory Developed Tests, which announced that...more
In the Food and Drug area, we don’t often get dramatic changes in FDA policies, but an announcement from the Secretary of HHS, published on August 18, appears to be just such a dramatic change. In the new announcement, HHS...more
With the coronavirus (COVID-19) pandemic showing no signs of abating, many digital health developers have refocused their technical expertise to develop products for use in the pandemic, including software apps for COVID-19...more
As the coronavirus (COVID-19) pandemic resurges, PREP Act liability immunity continues to be critical for manufacturers and users of COVID-19 medical products. ...more
On June 15, 2020, the U.S. Food & Drug Administration (FDA) revoked the Emergency Use Authorization (EUA) that permitted emergency distribution of chloroquine phosphate (CQ) and hydroxychloroquine sulfate (HCQ) from the...more
The US Food and Drug Administration (FDA) has been developing and shifting its guidelines for Personal Protective Equipment, or PPE, during COVID-19. The Agency has articulated its guidelines for PPE in one of two ways: (1)...more
Issues relating to liability for pharmaceutical, personal protective equipment (PPE) and diagnostic test businesses as well as for physicians and healthcare personnel in the coronavirus (COVID-19) context remains a salient...more
Immunity under the Public Readiness and Emergency Preparedness (“PREP”) Act is a moving target for government contractors and other companies manufacturing or distributing personal protective equipment (PPE) in the COVID-19...more
The Centers for Disease and Control and Prevention (CDC) is now recommending that the general public wear face masks to help slow the spread of COVID-19. Along with this recommendation, many businesses, individuals, and other...more
In response to a wave of questions from organizations looking to contribute to the fight against COVID-19, HHS recently clarified the bounds of immunity under the Public Readiness and Emergency Preparedness (PREP) Act, which...more
In response to increased concerns regarding insufficient personal protective equipment (“PPE”), the FDA recently issued an Emergency Use Authorization (“EUA”) applicable to face masks for use by both the general public and...more
The Background: Test manufacturers and labs are rushing to offer molecular and antibody tests for the novel coronavirus (COVID-19) to meet huge demand. Meanwhile, regulatory oversight during this national emergency has...more
All respirators approved by the National Institute of Occupational Safety and Health (“NIOSH”) now are “covered countermeasures” under the Public Readiness and Emergency Preparedness (“PREP”) Act provisions of the Public...more