The use of AI (artificial intelligence) in the life sciences industry has grown exponentially. While AI is increasingly being used to drive various processes and activities, AI software that could be used to read and interpret body language and facial expressions in the screening and hiring context has been proposed and is currently under scrutiny. We also asserted that as another significant regulatory trend, one of the most invaluable tools for organizations in the life sciences is Big Data. Today, analytics and experts are using Big Data to drive remarkable developments and changes across the life sciences industry. For instance, analytics across the pharmaceutical and healthcare sectors are utilizing Big Data in predicting issues such as the probability of hospital readmission, life expectancies, and genetic predispositions to particular conditions and illnesses. These applications include, but are not limited to, the advancement of new methods of treatment and the development of devices and drugs within the pharmaceutical and healthcare sectors.
As a continuation of this discussion, we have shifted gears and hammered on the role of the FDA (Food and Drug Administration) in managing plant closings and regulating the medical use of marijuana in our blog post titled “FDA on Plant Closings & Marijuana Regulation in Life Sciences” and part XXI of this series.
FDA on Plant Closings & Marijuana Regulation in Life Sciences
Manufacture, Regulation, and Use of Marijuana and Cannabis-based Products
For some time now, drug testing and the use of marijuana have been hot topics in the arena of labor law. Notably, given that the industry is required to address the growing efforts to regulate the marijuana industry as a whole (including the production, sale, and use of cannabis-based products for medical reasons) and the use of marijuana among employees, marijuana-related issues are of particular relevance to the life sciences industry. One key thing employers must note is that the use of marijuana has been a significantly controversial issue, and, therefore, it is important to be aware of the emerging legal issues arising and related to the use of the drug. Importantly, employers should be mindful of the specific laws regulating the use of marijuana among employees.
FDA Warnings and Plant Closings
Occasionally, layoff issues arise when, following regulatory violations and investigations, governments order the closure of plants operating in highly regulated industries, such as the life sciences industry. Over time, most plants operating within the industry are unable to comply with regulations because compliance gets increasingly complicated due to factors such as the ever-evolving customer needs, increased emphasis on innovation, heightened transparency expectations, and globalization.
To avoid potential violation of the federal WARN (Worker Adjustment and Retraining Notification Act of 1988), corresponding state mini-WARN acts, various state laws on mass layoffs and plant closings, and the eventual closure of plants, employers within the life sciences should make proactive efforts to comply with FDA enforcement regulations, as well as respond to warning letters effectively.
In Part XXII of this series and our blog titled “Life Sciences Industry Compliance with Administrative Regulations,” we shall move the discussion forward by hammering on a few of the regulatory requirements and guidelines that life sciences employers should comply with under state and federal agencies, including OSHA (Occupational Health and Safety Administration) and CDC (Center for Disease Control).
In the meantime, stay tuned for more legal guidance, training, and education. In the interim, if there are any questions or comments, please let us know at the Contact Us page!
Always rising above the bar,
Isaac T.,
Legal Writer & Author.