HHS Clarifies Broad Scope of Immunity Protection Under the PREP Act

The Department of Health & Human Services (HHS) has provided an omnibus advisory opinion in response to various requests for clarification of the scope of tort immunity provided by the declaration under the Public Readiness and Emergency Preparedness Act (PREP Act). The PREP Act declaration provides immunity from tort liability for various persons, products and activities in response to COVID-19, as explained in our March 17, 2020, Alert. The Coronavirus Aid, Relief and Economic Security Act (CARES Act) subsequently expanded these protections.

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

U.S. Food & Drug Administration Takes Steps to Allow Availability of PPE

Over the past week, the U.S. Food & Drug Administration (FDA) has taken a number of steps to enable manufacturers and distributors of face masks to more efficiently make their products available to the marketplace. FDA has accomplished this by establishing criteria that would allow manufacturers to bypass normally required (and often time-consuming) regulatory review.

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

PPE and Other Medical Devices from 3D Printing

During the COVID-19 pandemic, the demand for personal protective equipment (PPE) has significantly outpaced the capabilities of the traditional supply chain. Gowns, gloves, facemasks, and face shields are valued commodities that even many healthcare providers cannot secure in this environment. While traditional supply and manufacturing chains struggle to keep up with production, industry leaders have turned to 3D printing, or additive manufacturing technology, to address this dire need. Unlike traditional manufacturing methods, companies with already established additive manufacturing technologies can more readily and efficiently adapt their productions to manufacture such PPE. 3D printing manufacturers may already have the powder or fabric necessary to manufacture PPE. They also have versatile printers. These companies simply need software and product design specifications, which allows them to begin production much more quickly than companies relying on traditional manufacturing methods that require additional raw materials and even machines and equipment.

For example, Superfeet, a shoe insert manufacturer, which typically uses 3D printing for manufacturing its products, was contacted about its ability to assist with a shortage of powered air purifying respirators (PAPR) hoods to hospitals in Washington state. The company had printers and fabric already. In just a few short days, Superfeet was making PPE.

To read the full text of the article by Duane Morris , visit the MD+DI website.

Immunity Protections Expanded Under CARES Act for Covered Countermeasures and Healthcare Volunteers

As discussed in our March 18 Alert, the Secretary of Health and Human Services has issued a declaration authorizing drugs, devices and biologics used to treat or mitigate COVID-19 as covered countermeasures under the Public Readiness and Emergency Preparedness (PREP) Act. Following Secretary Azar’s declaration of a public health emergency, covered persons may obtain immunity under federal law for all claims arising from manufacturing, distributing or administering covered countermeasures, subject to the conditions laid out at 42 U.S.C. § 247d-6d, the declaration and other applicable regulations.

Subsequent to our previous Alert, President Trump signed into law the Coronavirus Aid, Relief and Economic Security Act (CARES Act), which expanded the covered countermeasure protections offered by the PREP Act.

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

CARES Act Package Ushers in Changes to OTC Drug Review Process

Most of the hundreds of pages comprising the CARES Act, signed into law on March 27, 2020, concern measures for directly counteracting COVID-19 and assisting those dealing with economic consequences of the pandemic. Yet tucked away in Subtitle F of the legislation are a number of provisions—now law—which streamline FDA’s over-the-counter (OTC) drug review process. These changes are likely to lower the regulatory burden of getting a product through the OTC drug review process and provide incentives of market exclusivity for companies who do.

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

COVID-19 Therapies: Protecting Against Government Intrusion

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.

Anti-Malaria Drugs Approved by FDA 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.

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. AshFrederick R. BallPatrick C. Gallagher, Ph.D.Jonathan LourieVicki G. Norton, Ph.D., or Sandra G. Stoneman of Duane Morris’ LIfe Sciences Industry Group.

A Cannabidiol Catalyst? Recent Events Increase Pressure on FDA to Regulate CBD

By Justin M.L. Stern and Frederick R. Ball

For consumers, the widespread availability of products containing cannabidiol (CBD) is old news. But for those in the cannabis industry—and in particular, those monitoring applicable regulatory developments—the state of CBD remains largely in flux and continues to be marred by uncertainty.

Under the 2018 Farm Bill, the U.S. Food and Drug Administration (FDA) retained its regulatory authority over products derived from hemp, including CBD incorporated into products it traditionally regulates, such as food, dietary supplements, and cosmetics. Unfortunately for the industry, FDA has yet to propose or issue formal regulations concerning the manufacture, distribution, or sale of such products. At the same time, FDA has issued numerous warning letters to producers and retailers incorporating CBD into products operating in the complex gray area between state and federal law. Nevertheless, recent events occurring across all three federal branches of government may reflect an impetus for change in FDA’s approach to CBD products.

To read the full article, please visit the FDLI website.

Protecting the Company’s Crown Jewels: Best Practices for Growth Stage Biotechnology Companies Using Contract Vendors in Support of Basic Research Activities

By Patrick C. Gallagher, Ph.D. and Sandra G. Stoneman

Emerging growth biotechnology companies often need to rely on third-party vendors and collaborators to fuel their research and development efforts.  These vendors and collaborators may perform crucial aspects of the R&D process, such as candidate screening, assay development and validation, and lead generation. To enable this work, biotechnology companies may be required to share their “secret sauce” (or the building blocks to an eventual secret sauce), like antibodies and their targets.  The following recommendations should be taken to account when working with third parties to balance the need to advance R&D with limited internal capacity and the need to maintain confidentiality of trade secrets and other proprietary information:

  • Strong work-product language—Ensure the contract has strong invention assignment and “work-for-hire” language.  Consider calling out specific antibodies and their targets as your “background intellectual property” or your materials. 
  • Confidentiality—Confidentiality obligations in the contract for trade secrets should survive for so long as the information qualifies as a trade secret under applicable law.
  • Subcontracting—Limit the ability of the vendor or collaborator to use subcontractors.  Understand the full supply chain and work flow, and the companies involved in each step.  For example, often vendors and collaborators want the ability to assign/subcontract to affiliates.  If that affiliate not qualified, this could present regulatory and IP protection issues.  Make sure you know who will actually have access to your confidential information and proprietary biological material.
  • Material transfer—If biological material is being transferred, consider entering into a separate “material transfer agreement” because most contract service agreements may not adequately address protections around sharing of material, and each time biological material is shared there likely will be specific limitations that will be appropriate to specify for the vendor.  At a minimum, ensure the contract limits the scope and nature of what the vendor is allowed to do with the biological material.  Also ensure that the contract requires return of all physical materials (often, the return obligations only apply to confidential information), and prohibits copying or replication except to the extent necessary for the contracted work.
  • Diligence your vendor or collaborator—ask for references, visit their location, periodically exercise audit and inspection rights under the contract.

It almost goes without saying that if a company is going to outsource R&D functions, there is some inherent risk that cannot be eliminated, but a good deal of the risk can be mitigated.

© 2009- Duane Morris LLP. Duane Morris is a registered service mark of Duane Morris LLP.

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

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