Morgan Lewis FDA, litigation, and healthcare lawyers authored a LawFlash outlining key issues that companies marketing products and services for coronavirus (COVID-19) should be aware of, including healthcare, FDA, clinical laboratory, product liability, and digital and telehealth laws and regulations. Many companies working on COVID-19 products, services, and treatments are not traditional healthcare or life sciences companies. This, however, is a highly regulated space, and regulators are continually issuing new policies and regulations. As companies lend their expertise to the battle against the pandemic, they should be aware of the relevant regulatory and legal requirements to avoid enforcement and liability risks.
The US Food and Drug Administration (FDA or Agency) on January 30 signaled what could be an about-face with regard to its role administering the List of Approved Drug Products with Therapeutic Equivalence Evaluation (referred to as the Orange Book). Historically, FDA’s Orange Book role has been solely ministerial. However, over the next year, FDA may begin taking a more active approach to the Orange Book.
As precision medicine gains momentum and in vitro diagnostics (IVDs) become increasingly used in clinical trials, pharmaceutical and biotechnology companies must quickly become familiar with the FDA’s investigational device framework. Based on concerns that drug clinical trial sponsors do not appreciate the need to follow device regulations when using “investigational” IVDs in clinical trials, in its draft guidance, FDA provides more structure around the incorporation of IVDs into clinical trials, and sets out its expectations about sponsors’ scope of review of the risk of use of such IVDs. The draft guidance will need to be factored into how pharmaceutical and biotechnology clinical trial sponsors use IVDs in clinical trials and work with device partners.