Recreational cannabis is now legal in 19 states and Washington D.C., driving the growth of legal cannabis sales estimated at $33 billion this year—up 32% from 2021—and expected to reach $52 billion by 2026.[1] This movement signals that financial investment in cannabis is not abating but accelerating notwithstanding the impact of the lingering COVID-19
FDA
FDA Releases Guidance for Digital Health Tech Used in Clinical Investigations
On December 22, 2021, the Food and Drug Administration (FDA) issued a draft guidance for sponsors, investigators, and other interested parties on using digital health technologies (DHT) to acquire data remotely from participants in clinical investigations. DHTs (such as wearables and sensors) are playing a growing role in clinical research, accelerated by the need for…
Waiver Of Intellectual Property Protections For COVID-19 Vaccine Unlikely To Have Meaningful Impact In Short Term
By Lorna Tanner & Thomas Carr*
On Wednesday, May 7, 2021, the United States officially endorsed waiving intellectual property protections for COVID-19 vaccines. While the United States has taken the opposite position in recent months, the administration asserts that its departure is guided, at least in part, by the goal “to get as many safe and effective vaccines to as many…
FDA Proposes Risk-Based and Remote Inspection Strategies in New Report
On May 5, 2021, the U.S. Food and Drug Administration (FDA) issued a much-anticipated report, “Resiliency Roadmap for FDA Inspectional Oversight,” which provides a roadmap for the agency’s post-pandemic plans to return to a consistent state of inspection operations. For the near term, FDA reports that it will continue to prioritize critical inspections…
Breaking Down FDA’s New Remote Monitoring Strategy
On Wednesday, April 14, 2021, the US Food and Drug Administration (FDA) published a long-awaited final guidance document explaining its policy for conducting remote “evaluations” during COVID-19. According to the guidance, FDA will request and conduct voluntary remote evaluations at (1) facilities where drugs and biologics are manufactured, processed, packed, or held; (2) facilities covered…
FDA Announces Facility Fees for OTC Drug Manufacturers
On Friday, March 26, 2021, FDA published a Federal Register notice, “Fee rates under the Over-The-Counter Monograph Drug User Fee Program for Fiscal Year 2021,” announcing 2021 fee rates under its over-the-counter (OTC) monograph drug user program. This is the first year that FDA has collected user fees from OTC drug manufacturers and…
“Hope Is On The Horizon”: California Governor Gavin Newsom Announces COVID-19 Vaccine Distribution Plan
N.B. Concurrent with the posting of this article, the Vaccines and Related Biological Products Advisory Committee of the Food and Drug Administration (“FDA”) has decided to recommend to the FDA that the FDA approve the emergency use authorization applications submitted by Pfizer and BioNTech. It is being reportedd that the FDA may formally approve the…
Cannabis Gets Go-Ahead from House, But Still Faces Hurdles Before Federal Legalization
On Friday, the United States House of Representatives voted to approve The Marijuana Opportunity and Expungement Act (MORE Act),[1] which would decriminalize cannabis. This vote marks the first time that a chamber of Congress voted on a standalone cannabis bill. While the 228-164 vote passed mostly on party lines, 5 Republicans voted in support…
Green Wave: The Latest Election Cycle Brings Hope for Standardized Cannabis Legalization
Even two weeks after Election Day, jurisdictions nationwide are riding high after a number of positive wins related to the possible systemic legalization of cannabis use nationwide. As of November 3, 2020, the pendulum now undeniably swings in favor of cannabis, with medical cannabis legal in 33 states and recreational adult-use permitted in 12 states…
FDA Update: The Latest on Vaccine Development, Inspections, and Conducting Clinical Trials During Covid-19
This week, FDA Commissioner Stephen M. Hahn, M.D., along with Dr. Anthony S. Fauci, M.D., of the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health, and officials from the Centers for Disease Control and Prevention and U.S. Department of Health and Human Services testified on Capitol Hill on the federal response…
Up in Smoke: COVID-19’s Impacts on Hemp & Cannabis M&A
It would be an understatement to say that the COVID-19 pandemic impacted transactional activity for buyers and sellers across a range of industries, the hemp and cannabis merger and acquisition (“M&A”) space being no exception. In particular, the current period of COVID-19 volatility in the hemp and cannabis space is marked by numerous consequential outcomes,…
FDA Announces Plans to Resume Domestic On-site Inspections
On July 10, 2020, Commissioner Hahn of the U.S. Food and Drug Administration (FDA) issued a statement announcing that the agency is planning to resume on-site inspections of domestic facilities during the week of July 20. The Agency has developed a “COVID-19 Advisory Level” risk-based rating system to help assess where inspections may safely resume. …
COVID-19’s Continued Impacts on Cannabis Operators
As the novel coronavirus (COVID or COVID-19) continues to ravage the United States, the cannabis industry is feeling the pandemic’s negative impacts despite an initial spike in sales after cannabis operations were deemed essential under various state “stay-at-home” orders.[1] This article details the most recent state-level responses activated in California and Illinois.
California…
FDA Issue Guidance on Manufacturing Drugs, APIs during COVID-19
FDA issued new guidance on June 19, 2020, advising manufacturers of drugs, biologics, and active pharmaceutical ingredients (APIs) on manufacturing controls to prevent contamination of drugs with SARS-CoV-2, including performing risk assessments to determine whether the virus poses new risks to drug products, or to the manufacturing facilities or processes that produce them. FDA is…
Navigating FDA Policies for PPE, and Liability Protections
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) through guidance documents and (2) through issuance of “umbrella” Emergency Use Authorizations (EUAs) that cover certain product types. EUAs…
Not So Fast – FDA Retracts Authorization for Some Respirators Made in China
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 public health response. We wrote previously about new liability protections afforded to manufacturers and distributors of certain face masks approved by National Institute for Occupational…