Health Law Scan

In our latest Fast Break session and on the heels of recent announcements from the Biden-Harris administration and the US Food and Drug Administration’s (FDA’s) granting of full authorization for the Pfizer vaccine in August, we discussed how these updates may impact employers in the healthcare industry.

Our US Food and Drug Administration (FDA) team recently published a blog post discussing the FDA’s issuance of its first clinicaltrials.gov notice of noncompliance to a clinical trial sponsor for failure to submit clinical trial results to the National Institutes of Health databank. While the authority to issue such notices has existed since the 2007 passage of the Food and Drug Administration Amendments Act, this is the first time the FDA has exercised its clinicaltrials.gov enforcement authority.

Our FDA team recently published an Insight covering key considerations for artificial intelligence (AI) healthcare application developers and users, highlighting the FDA’s current regulatory scheme for AI/machine learning (ML)-based software, potential FDA enforcement discretion that may apply, and recent FDA developments impacting AI/ML technologies. This Insight may be of interest to clients and friends of Health Law Scan.

Members of our vaccine taskforce recently published an important Insight outlining a selection of key legal considerations and updates as the COVID-19 vaccine rollout continues to take shape, including the status of the US Food and Drug Administration’s vaccine products, distribution, key legal issues at the state level, employer mandates and employee incentives, and important liability concerns.

Morgan Lewis has recently launched a new resource for our clients and friends, Questions on Vaccines, to help navigate as the US accelerates its goal of delivering safe and effective COVID-19 vaccines, employers, healthcare providers, and many others are considering the potential implications for their industries and organizations.

Our FDA and digital health teams recently published a LawFlash on how a Biden administration will affect the US Food and Drug Administration’s (FDA’s) oversight and regulation of medical devices and digital health. The most immediate and significant changes impacting FDA’s medical device oversight are likely to include a repeal of certain Trump administration orders on regulatory reform and changes in leadership at both FDA and the US Department of Health and Human Services (HHS). Certain FDA priorities, however, including efforts to prioritize COVID-19-related medical devices and digital health technologies, are expected to continue under the new administration. Device companies should be prepared for an uptick in FDA enforcement activity, including those that received Emergency Use Authorizations (EUAs) for products intended to aid in COVID-19 relief efforts.

Our FDA team published a LawFlash on the Food and Drug Administration’s (FDA’s) recent Emergency Use Authorizations (EUAs) for the first over-the-counter (OTC) COVID-19 test to be performed at home and the first OTC home sample collection kit for COVID-19 testing, as well as additional prescription at-home tests and sample collection kits. These newly authorized testing options are expected to help address the critical public health need for additional COVID-19 test capacity. FDA’s authorization of these new EUAs also makes good on promises the FDA made to prioritize its review of rapid and at-home test solutions.

HHS recently announced the forthcoming termination of FDA’s Unapproved Drugs Initiative (UDI), in an apparent effort to combat prescription drug shortages and price spikes. This announcement essentially walks back FDA’s enforcement approach regarding “marketed unapproved drugs,” allowing them to continue to be sold consistent with the 2006 FDA policy. Although the incoming Biden administration may ultimately decide to reinstitute the UDI program, unapproved drugs may be excluded from coverage by Medicare and Medicaid and by private health plans that follow federal plan coverage standards.

Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), all pesticide products (including surface sanitizing products) must be registered with the Environmental Protection Agency (EPA) prior to sale, distribution, or use in the United States. EPA maintains a list of pesticide products that should kill the SARS-CoV-2 virus, called List N. EPA recently released new interim guidance allowing it to expedite review of some applications for new and amended registrations for products intended to kill SARS-CoV-2.

Our FDA team recently posted a LawFlash about the US Department of Health and Human Services (HHS) August 19 announcement, Rescission of Guidances and Other Informal Issuances Concerning Premarket Review of Laboratory Developed Tests, in which it stated that the FDA would not require premarket review of laboratory developed tests (LDTs) without notice-and-comment rulemaking. The announcement has implications not only for LDTs intended for SARS-CoV-2 testing, but also for LDTs intended for other purposes, such as pharmacogenetic testing and direct-to-consumer testing.