General – Page 11 – Duane Morris Life Sciences Law

March 31, 2020April 1, 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, 2020March 30, 2020 by Duane Morris

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.

March 26, 2020 by Duane Morris

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.

March 18, 2020March 20, 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.

As the guidance recognizes, there is currently an outbreak of a respiratory virus named SARS-CoV-2, which causes a disease named Coronavirus Disease 2019 (hence COVID-19). The guidance also acknowledges that COVID-19 poses a high potential public health threat “both globally and to the United States.” Effectively responding to the COVID-19 outbreak requires “rapid detection of cases and contacts, appropriate clinical management and infection control, and implementation of community mitigation efforts.”

To that end, the guidance describes a number of important policies concerning the circumstances under which certain entities may perform laboratory testing or distribute test kits on a more expedient timeline than would normally be permitted under FDA regulations and policies.

View the full Alert on the Duane Morris LLP website.

March 18, 2020March 20, 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.

Declaring a public health emergency under the PREP Act provides covered persons with immunity from liability under federal or state law for all claims arising from administration to or use by an individual of a Covered Countermeasure. Under the statute, 42 U.S.C. § 247d-6d, immunity applies if the medical countermeasure:

View the full Alert on the Duane Morris LLP website.

January 30, 2020 by Frederick R. Ball

Sandra Stoneman named to U.S. News/Best Lawyers “The Best Lawyers in America” 2020 in Life Sciences

Congratulations to our colleague and corporate partner, Sandra Stoneman, who was recently selected by her peers for inclusion in U.S. News/Best Lawyers “The Best Lawyers in America” 2020 in the field of Biotechnology and Life Sciences. Sandra serves as a team lead for the Duane Morris Life Sciences and Medical Technologies industry group.

ABOUT BEST LAWYERS

Best Lawyers is the oldest and most respected lawyer ranking service in the world. For almost 40 years, Best Lawyers has assisted those in need of legal services to identify the lawyers best qualified to represent them in distant jurisdictions or unfamiliar specialties. Best Lawyers lists are published in leading local, regional, and national publications across the globe.

October 8, 2019 by Duane Morris

FDA Warns Florida Company: CBD Oil is Not a Dietary Supplement

Despite recent bipartisan calls on the FDA to regulate hemp-derived CBD products, the U.S. Food & Drug Administration appears to be adhering to the status quo, at least with respect to issuing warning letters to companies deemed noncompliant with existing regulations. Case in point: on September 18, 2019, the FDA issued a warning letter (posted to the FDA’s website last week) to Alternative Laboratories, a dietary supplement manufacturer based in Naples, Florida.

According to the letter, the FDA conducted an inspection of Alternative’s dietary supplement manufacturing facility over five days in May and June; the inspection focused on the adequacy of labels for certain products manufactured and distributed by the company.

To read the full text of this blog post by Duane Morris attorney Justin M. L. Stern, please visit the Duane Morris Cannabis Industry Blog.

October 3, 2019 by Duane Morris

FDA’s New Medical Device Rules Speed Up Review Process

This was originally published in Law360.

With the advancements in technology and the advent of artificial intelligence, the medical device industry is flourishing. But regardless of the type of technology involved, the U.S. Food and Drug Administration must clear the device for marketing before any commercialization of a medical device.

There are typically three mechanisms for seeking FDA clearance for a medical device: a 510(k) submission, a de novo classification request and a premarket approval application. The FDA will not accept a 510(k) application unless the applicant can demonstrate that the device is at least as safe and effective (i.e., substantially equivalent to) a device that has already obtained FDA clearance (i.e., a predicate device).

For the full article by Frederick R. Ball and Carolyn A. Alenci, visit the Duane Morris LLP website.

September 20, 2019September 20, 2019 by Duane Morris

Duane Morris Recognized by LMG Life Sciences Awards for Role in Hatch-Waxman Impact Case of the Year

Duane Morris LLP was honored for its role in a Hatch-Waxman Impact Case of the Year at the Legal Media Group (LMG) Life Sciences Awards 2019. The case was Teva Pharmaceuticals et al v. Sandoz et al. (Fed. Circ. 2018), where the firm represented Amneal.

Duane Morris was also shortlisted as a “Firm to Watch – Financial & Corporate” and partner Anthony J. Fitzpatrick in Boston was named a finalist for “General Patent Litigator of the Year – New England.”

For more information, read the news release.

April 4, 2019 by Duane Morris

FDA Announces Its Next Steps for Cannabis Products

With the enactment of the Agriculture Improvement Act of 2018 (also known as the 2018 Farm Bill), hemp-derived CBD appeared to be on the table for marketing all across the country. However, the U.S. Food and Drug Administration’s (FDA) press release issued that same day put a hold on the jubilation, stating that FDA considered any and all cannabis-containing or cannabis-derived products as drug products and not food or dietary supplements, regardless of whether the CBD was hemp-derived.

On April 2, 2019, departing FDA Commissioner Scott Gottlieb issued a statement about FDA’s next steps to advance a regulatory pathway for cannabis-containing and cannabis-derived products. At the same time FDA updated its cannabis-containing products and cannabis-derived products Q&A. It is clear that, at this point, FDA has not changed its position.

Read the full Alert on the Duane Morris LLP website.