Insights

On April 2, 2025, the U.S. Supreme Court extended the reach of Section 1964(c) of the Racketeer Influenced and Corrupt Organizations (RICO) Act by holding that a plaintiff may seek treble damages for a business or property loss resulting from a personal injury.[1] The 5-4 decision has resolved a 3-2 circuit split over whether the RICO statute precludes relief for losses stemming from a personal injury.

When a company learns that it may wind up as a defendant in a multidistrict litigation (or MDL), it may initially feel like a disaster. Between expensive, drawn out, and complicated legal proceedings and the possibility of outsized damages and company-threatening liability, it is difficult to imagine the upside. However, MDLs may not be as unfavorable a forum for defendants as they initially seem.

Artificial intelligence (AI) and machine learning (ML) have become ubiquitous across industries, and the pharmaceutical industry is no exception. AI and ML are already influencing drug development and manufacturing, but these innovations present unique regulatory challenges. For example, if a ML algorithm can change a CGMP-compliant manufacturing process on its own to increase efficiency, how does the drug manufacturer ensure that the updated, machine-created process is CGMP-compliant? If researchers use AI to identify ideal candidates to participate in a drug trial, how do they account for biases in the data underlying the AI’s decision-making? FDA recently released a discussion paper[1] requesting input from pharmaceutical industry stakeholders on how to tackle such issues. Stakeholders should seize this opportunity to provide input to FDA as the agency develops the applicable regulatory landscape.

In March, 2020, the U.S. Food and Drug Administration (“FDA”) announced that the Agency would temporarily halt domestic facility inspections not deemed “mission-critical,” citing health concerns related to the COVID-19 pandemic. On July 10th, FDA announced its plans to resume domestic on-site facility inspections during the week of July 20th. 

On May 8, 2020 the U.S. Food and Drug Administration (“FDA”) shared a checklist of best practices for re-opening retail food establishments (including restaurants) during the COVID-19 pandemic. According to FDA, this checklist establishes key food safety practices, but is not an exhaustive list. FDA recommends that retail food establishments work with local health and regulatory authorities to discuss requirements for safely re-opening.

On April 9, 2020, the U.S. Food and Drug Administration (FDA) shared recommendations on best practices for food retail stores, restaurants, and food pick-up and delivery services during the COVID-19 pandemic. According to the FDA, companies should follow these practices to better protect their food industry workers and consumers. Further, compliance with these policies could also reduce the risk of future litigation if, for example, plaintiffs seek to hold companies responsible for the spread of COVID-19.

Following its recent decision to lift certain restrictions on the sale of packaged foods, the U.S. Food and Drug Administration (FDA) has taken further steps to increase flexibility with respect to packaging and labeling requirements for shell eggs. FDA issued this temporary policy to “meet the increased demand for shell eggs during the COVID-19 pandemic.”

Continuing its efforts to ensure a continuous and safe supply of food during the COVID-19 Public Health Emergency, on April 5, 2020, the U.S. Food and Drug Administration (FDA) updated its Questions & Answers for Industry on food safety and COVID-19 to address social distancing in food production/processing facilities and retail food establishments where employees typically work in close proximity.

As a result of the COVID-19 Pandemic, restaurants may have food on hand that they can no longer use to prepare food for patrons. Similarly, food manufacturers may have inventory labeled for use in restaurants that is no longer in demand by the restaurant industry. To encourage the further distribution of this food during the ongoing public health emergency, which may otherwise go to waste, the U.S. Food and Drug Administration (“FDA”) temporarily changed its policy to allow restaurants and food manufacturers to sell packaged foods (intended for restaurant use), that lack Nutrition Facts labels, directly to consumers and businesses. Under normal circumstances, if restaurants sell packaged foods directly to consumers, or to other businesses for sale to consumers, nutrition information may be required. See 21 CFR 101.9(a)(1) and 101.9(j)(2).

In response to the recent COVID-19 pandemic, the U.S. Food and Drug Administration (“FDA”) has temporarily paused all domestic and international on-site inspections not deemed “mission-critical.”

This article is the third installment of a four-part series which leverages available FDA enforcement data from 2016 to present, with an emphasis on the pharmaceutical and medical device industries, to provide companies with insight on how to best comply with FDA regulations and avoid common pitfalls in 2020. The first installment in this series focused on trends in FDA inspections. The second installment focused on Form 483 Inspectional Observations. This article will address FDA Warning Letters which are formal notifications issued by senior FDA officials to notify a company of violations of regulatory significance. FDA considers this to be the Agency’s primary means to achieve prompt, voluntary compliance and ensure that management allocates appropriate resources to fully correct violations and prevent recurrence.

This article is the second installment of a four-part series which leverages available FDA enforcement data from 2016 to present, with an emphasis on the pharmaceutical and medical device industries, to provide companies with insight on how to best comply with FDA regulations and avoid common pitfalls in 2020. The first installment in this series focused on trends in FDA inspections. This article will focus on the most common FDA enforcement action that may follow from an inspection, Form 483 Inspectional Observations – most commonly referred to in the industry as simply “483s.”

While the number of enforcement actions implemented by the Food and Drug Administration (FDA) has decreased throughout the years – the quantitative data tells only part of the story. A review of this past year’s enforcement actions reveal that the agency remains committed to enforcing compliance with its regulations by utilizing a risk-based approach to advance its public health priorities and minimize public health risk.