treatment – Page 2 – Coronavirus (COVID-19)

April 7, 2020August 31, 2020 by Duane Morris

Protecting Against Government Intrusion for COVID-19 Therapies

As the COVID-19 pandemic continues to disrupt our lives, wreak havoc on our economy and force millions to social distance, shelter at home or even quarantine, scientists across the globe have turned their focus and expertise to developing new treatments and vaccines aimed at containing the effects of this virus.

The need for this life-saving work has never been more apparent or more urgent. We owe them a sincere debt of gratitude as our lives may literally depend on their success. And as the hard work of these scientists starts to bear fruit, the demand for these treatments will be so urgent and of such magnitude that no single company will likely be able to scale up, manufacture and distribute the treatment to all those in need.

The U.S. government has several options at its disposal to intervene―if necessary―to ensure a low priced treatment is rapidly made available to those in need.

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

April 7, 2020September 4, 2020 by Duane Morris

How COVID-19 Could Shake Up Patent Strategies

The coronavirus pandemic may spur new thinking about patent issues, as owners of relevant patents face the risk of backlash for asserting them, and companies developing equipment or treatments consider ways to limit potential liability. […]

There has already been public outcry over patents related to COVID-19, and such responses will likely grow in intensity if an effective treatment is seen as being hindered by patents. So companies may have to think about using their patents differently than they normally would, attorneys say. […]

“Most companies are thinking differently right now than they were six months ago,” Patrick Gallagher of Duane Morris LLP said. “I would think there would definitely be hesitancy around pursuing [an infringement case] right now.” […]

To read more of Mr. Gallagher’s comments and for a link to the full article, please visit the firm website.

April 6, 2020August 31, 2020 by Duane Morris

HHS Office of Civil Rights Issues Bulletin Regarding COVID-19 and Civil Rights Issues and Resource Allocation

By Colin Knisely

In response to a complaint from disability advocacy groups in Washington state regarding health care rationing, the Department of Health and Human Services (HHS) Office of Civil Rights (OCR) issued a reminder to entities covered by federal civil rights statutes of their ongoing obligation, amid the COVID-19 crisis, to prohibit discrimination on the base of race, color, national origin, age, religion, sex, and disability. OCR is responsible for enforcing the Americans with Disabilities Act (ADA), Section 1557 of the Affordable Care Act, and Section 504 of the Rehabilitation Act. The bulletin reminds covered entities that “persons with disabilities should not be denied medical care based on stereotypes, assessments of quality of life, or judgments about a person’s relative ‘worth’ based on the presence or absence of disabilities.” Continue reading “HHS Office of Civil Rights Issues Bulletin Regarding COVID-19 and Civil Rights Issues and Resource Allocation”

April 3, 2020August 31, 2020 by Duane Morris

FDA-Approved Anti-Malaria Drugs for COVID-19 Treatment Fall Within Liability Shield of the PREP Act

The Food and Drug Administration (“FDA”) gave emergency approval this week to two (2) anti-malaria drugs, hydroxychloroquine and chloroquine, to be used for treatment of COVID-19 patients. Despite the limited studies as to the benefits of these drugs and the well-known risks of these drugs, the FDA took the position that, under the current circumstances, the potential benefits and effectiveness outweigh the risks. While the FDA is conducting a trial as to the effectiveness of these drugs, millions of doses have already been shipped to hospitals nationwide for administration in an attempt to slow the spread of COVID-19.

To read the full text of this post by Duane Morris attorney Brittany Wakim, please visit the Duane Morris Products Liability Blog.

April 1, 2020August 31, 2020 by Duane Morris

FDA Unveils Program to Expedite Coronavirus Treatments

On March 31, 2020, the U.S. Food & Drug Administration (FDA) introduced a specially designed “emergency program”—dubbed the Coronavirus Treatment Acceleration Program (CTAP)—to provide patients with faster access to new COVID-19 treatments. The CTAP allows FDA to “move new therapies to patients as quickly as possible, while at the same time finding out whether they are helpful or harmful.”

Given the rapidly increasing rate of COVID-19 confirmed cases and fatalities in the United States, efforts to streamline FDA processes may prove crucial to uncovering and delivering viable treatments.

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

March 31, 2020August 31, 2020 by Duane Morris

FDA Virtual Town Hall for Laboratories and Manufacturers Developing Diagnostics Tests for COVID-19

FDA is hosting a virtual town hall April 1, 2020, at 12:15 p.m. Eastern for clinical laboratories and commercial manufacturers developing diagnostic tests for the COVID-19 virus. FDA intends to help answer technical questions about validation and development of tests and FDA’s recently issued Guidance from March 16, 2020 outlining FDA policy for development of diagnostic tests during the COVID-19 public health emergency. FDA will host subsequent virtual town halls for clinical laboratories and commercial manufacturers each Wednesday of April at 12:15 p.m. Eastern. Registration not required. Details to join the call are available on the event page.

For additional information, please contact Dana J. Ash, Frederick R. Ball, Patrick C. Gallagher, Ph.D., Jonathan Lourie, Vicki G. Norton, Ph.D., or Sandra G. Stoneman of Duane Morris’ LIfe Sciences Industry Group.

March 30, 2020September 3, 2020 by Duane Morris

Phase III of COVID-19 Stimulus Package May Affect Pharmacies Filling Medicare Prescriptions

By Jonathan L. Swichar, Bradley A. Wasser and Coleen W. Hill

Phase III of the Covid-19 stimulus package may affect pharmacies filling Medicare prescriptions in various ways. Continue reading “Phase III of COVID-19 Stimulus Package May Affect Pharmacies Filling Medicare Prescriptions”

March 24, 2020September 1, 2020 by Duane Morris

U.S. Army Corps of Engineers to Award Contracts to Convert Existing Buildings into ICU-like COVID-19 Treatment Facilities, Starting in New York

During a press conference on March 20, 2020, the U.S. Army Corps of Engineers (USACE) discussed plans to assist state-level COVID-19 relief efforts. USACE support will include the conversion of existing, underutilized buildings such as hotels, college dormitories and potentially large spaces into ICU-like treatment facilities. Specifically, state governments will nominate and lease facilities, USACE will award construction contracts for building modifications, FEMA and/or HHS will provide necessary supplies, and then state governments will provide staffing.

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

March 18, 2020August 31, 2020 by Duane Morris

FDA Guidance Aims to Accelerate Availability of COVID-19 Tests

On March 16, 2020, the U.S. Food & Drug Administration (FDA) issued new guidance aimed at accelerating the availability of COVID-19 diagnostic tests developed by laboratories and commercial manufacturers. The guidance, which took immediate effect upon release, contains recommendations for clinical laboratories and commercial manufacturers regarding development of diagnostic tests for COVID-19 during the current public health emergency.

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

March 18, 2020August 31, 2020 by Duane Morris

Declaration Provides Immunity for Certain COVID-19 Pandemic Medical Countermeasure Activities

In an effort to encourage development of drugs, devices and biologics useful for the treatment, diagnosis, and prevention of COVID-19 respiratory illness, the Secretary of Health and Human Services has issued a declaration providing statutory immunity under the Public Readiness and Emergency Preparedness (PREP) Act. This declaration is separate from the Public Health Emergency declared under Section 319 of the Public Health Service Act on January 31, 2020, and is a part of the continued effort by the federal government to expedite development and distribution of medical products that can address the COVID-19 pandemic.

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