FDA’s Thinking on Imposition of Civil Monetary Penalties for Violations of Clinical Trial Reporting Requirements Revealed by New Guidance

In August 2020, the U.S. Food and Drug Administration issued guidance on the imposition of civil monetary penalties for violations of clinical trial reporting requirements. The new guidance is welcome insight for members of the pharmaceutical, biologics and medical device industries, particularly in light of the race to develop—and convince FDA of the safety and effectiveness of—COVID-19 vaccines, therapeutics and diagnostic tests.

To read the full text of this Duane Morris Alert, please visit the firm website.

Gatherings of Up to 25 People Allowed in Phase III Regions in New York and Western New York to Enter Phase III Tomorrow

By Minhee Lee

Governor Cuomo announced today that global public health experts have given Western New York the green light to enter Phase III reopening, joining five other New York regions already in Phase III— Central New York, the Finger Lakes, the Mohawk Valley, the North Country, and the Southern Tier. The Capital Region, which encompasses Albany, the state capital, is on track to follow suit on Wednesday, June 17. Gatherings of up to 25 people will also be permitted in regions currently in or entering Phase III. This is an expansion from the previous restriction of 10 people.

The benchmark numbers continue to go down according to the press release—the three-day average on COVID-19 related hospitalizations and fatalities has hit the lowest point since the beginning of the pandemic. Only 1.1% of 56,611 tests that took place across the state yesterday came back positive. Even in New York City, the state’s COVID-19 epicenter, the testing came back positive at a rate of 1.3% on Sunday, down from 1.4% on Saturday, and 1.7% on Friday. New York City is currently in Phase I.

CDC Provides Guidance on COVID-19 Antibody Testing

On May 26, 2020, the Centers for Disease Control and Prevention issued interim guidelines for COVID-19 antibody testing in clinical and public health laboratories. The guidelines contain recommendations for clinical and public health laboratories regarding: choice of test and testing strategy; individuals who test positive for COVID-19 antibodies; and additional considerations on the use of antibody tests.

To read the full text of this Duane Morris Alert, please visit the firm website.

U.S. Pharmacists and Pharmacies Authorized to Order and Administer COVID-19 Diagnostic Tests

In further clarification to pharmacists and pharmacies around the country, on May 19, 2020, the Department of Health and Human Services (HHS) issued an advisory opinion determining that pharmacies in the United States, regardless of state or local requirements, are authorized to order and administer COVID-19 diagnostic tests under the Public Readiness and Emergency Preparedness (PREP) Act.

To read the full text of this Duane Morris Alert, please visit the firm website.

California Executive Order Presumes Employees Who Contract COVID-19 Are Eligible for Workers’ Compensation Benefits

By Brooke B. Tabshouri

On May 6, 2020, Governor Gavin Newsom issued Executive Order No. N-62-20. The order states that employees will be presumed to have contracted COVID-19 in the course and scope of employment for purposes of workers’ compensation benefits if all of the following conditions are satisfied:

  • The employee contracts it within 14 days of performing labor at the employer’s direction and at the employer’s worksite;
  • If such work occurred on or after March 19, 2020;
  • The worksite was not the employee’s home; and
  • The positive test is confirmed by a physician within 30 days.

Continue reading “California Executive Order Presumes Employees Who Contract COVID-19 Are Eligible for Workers’ Compensation Benefits”

Pennsylvania Announces Methodology for Phased Re-Opening Approach

Governor Wolf elaborated on the PA Department of Health metrics for Re-Opening and included an example to aid in calculation. A target goal for reopening has been set at having fewer than 50 new confirmed cases per 100,000 population reported to the department in the previous 14 days. An assessment will determine if the target goal has been met. The administration will work closely with county and local governments to enable the communities to reopen and transition back to work.

To read the full post by Duane Morris partner Brad Molotsky, please visit the Duane Morris Project Development/Infrastructure/P3 Blog.

Maryland Governor Announces Three-Stage Plan for Reopening the State

By Robert B. Hopkins, Carla N. Murphy and Allison M. Midei 

On Friday afternoon, Maryland Governor Larry Hogan announced a three-stage plan to reopen the State called “Maryland Strong: Roadmap to Recovery,” which will gradually ease the current restrictions on businesses, congregate settings and social interactions. The plan is based on the recovery plans issued by the federal government, the National Governors Association, Johns Hopkins and the American Enterprise Institute. Continue reading “Maryland Governor Announces Three-Stage Plan for Reopening the State”

EEOC: Employers Can Screen for COVID-19

The Equal Employment Opportunity Commission (EEOC) updated its guidance on April 23 on the Americans with Disabilities Act (ADA) and coronavirus, explaining that employers may screen employees for COVID-19. Any mandatory medical test must be job-related and consistent with business necessity, the EEOC explained. […]

Questions about testing are “increasingly on the minds of employers,” said Christopher Durham, an attorney with Duane Morris in Philadelphia. […]

In an April 17 update to the same guidance, the EEOC clarified what constitutes an undue hardship preventing an employer from reasonably accommodating an individual with a disability in a pandemic. The agency stated that “it may be significantly more difficult in this pandemic to conduct a needs assessment or to acquire certain items, and delivery may be impacted, particularly for employees who may be telecommuting.” […]

The factors impacting what constitutes an undue hardship are going to be motivated by a vastly different operational and financial reality for some businesses than was the case prior to the pandemic, said Linda Hollinshead, an attorney with Duane Morris in Philadelphia.

To read the full text of the article, including further commentary by Mr. Durham and Ms. Hollinshead, please visit the SHRM website.

Webinar: How COVID-19 Is Affecting Life Sciences and Medical Technologies

Duane Morris will be hosting the webinar, “How COVID-19 Is Affecting Life Sciences and Medical Technologies,” on April 16, 2020, from 1:00 p.m. to 2:00 p.m. (Eastern).

Join Duane Morris attorneys for a discussion on how the life sciences and medical technologies industry is responding and adapting to the COVID-19 pandemic, including:

  • FDA’s Emergency Use Authorizations (EUAs) for devices and diagnostics testing policies
  • Public Readiness and Emergency Preparedness Act (PREP Act) immunity from liability
  • Implications on intellectual property, such as patent strategy, in biotechnology and pharmaceuticals
  • License and collaboration agreements in the wake of COVID-19

For more information and to register, please visit the firm website.

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The opinions expressed on this blog are those of the author and are not to be construed as legal advice.

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