Insights

The Food and Drug Administration (FDA) has published revised draft guidelines in the Federal Register on promotional labeling and advertising considerations for the biologic and biosimilar industry, updating guidance from 2020. The quick revisions emphasize the fast-changing and rapidly growing nature of this industry.

In late December, the FDA released a guidance document that provides clarity for small businesses marketing direct-to-consumer (DTC) drug products on television or radio.  The Q&A followed the FDA’s November 2023 Final Rule amending DTC advertising regulations for prescription drugs. 

What do consumers think when they see a label on a package of supermarket chicken, beef or pork, stating that the meat has been “humanely raised?” The final week of February 2021 witnessed two important developments that shed light on a burgeoning legal attack on certain farming production and advertising practices. 

To put it mildly, 2020 was a year full of changes—including changes to the federal court rules of procedure. As litigants prepare for a new year of court proceedings, they should bear in mind several of these rule changes.

On October 7, 2020, the U.S. Food and Drug Administration (“FDA”) issued a warning letter to Battelle Memorial Institute (“Battelle”) for failing to adhere to Emergency Use Authorization (“EUA”) requirements for its N95 mask decontamination units. Battelle’s decontamination system, designed to sanitize N95 masks for healthcare professionals and thereby mitigate the shortage of N95 masks, was granted an EUA on March 28, 2020.

Widespread testing has been considered one of the country’s best ways to help minimize the spread of COVID-19, by allowing for quick identification, isolation, and treatment of infected individuals before further spread the virus.  To this end, the Department of Health and Human Services (HHS) has recognized that pharmacists are uniquely positioned to aid in COVID-19 testing expansion, as they are trusted health care professionals who have established relationships with both their patients and medical providers, and also have the ability to refer patients to hospitals when necessary.  On May 19, 2020, HHS issued an Advisory Opinion (Opinion) on the Public Readiness and Emergency Preparedness (PREP) Act, making it clear that the PREP Act shields pharmacists from liability stemming from ordering and administering FDA-authorized COVID-19 tests. 

At the outset of the COVID-19 pandemic, the U.S. Food and Drug Administration (FDA) barred the importation of various personal protective equipment (PPE) from abroad – particularly from China. However, in response to PPE shortages caused by the crisis, FDA changed course. As noted in a previous alert, on April 3, 2020, the Agency issued an Emergency Use Authorization (EUA) permitting the importation of non-NIOSH approved filtering face-piece respirators (respirators) manufactured in China, including KN95 masks. The April 3 EUA allowed dozens of manufacturers of masks made in China to begin importing and distributing their products as respirators within the U.S. However, on May 7, 2020, the FDA yet again changed course and revised the April 3, 2020 EUA for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China to revoke authorization for over 50 Chinese manufacturers to market non-NIOSH approved face masks as respirators under the EUA.  

In another step towards helping ease shortages in medications needed to treat hospitalized COVID-19 patients, the United States Food and Drug Administration (FDA) issued a Final Guidance regarding non-registered compounding facilities’ role in alleviating COVID-19 drug shortages. In a prior Final Guidance issued last week, FDA noted that it would ease regulatory restrictions on 503B outsourcing facilities in order to allow these facilities to compound drugs currently in shortage for COVID-19 patients. Similarly, this new guidance eases restrictions on compounding facilities that are not registered as outsourcing facilities. The Agency noted that this was an additional step towards mitigating drug shortages, as “FDA understands that during the COVID-19 public health emergency, even with the regulatory flexibility provided in the guidance for [Outsourcing Facilities], the drugs compounded by outsourcing facilities also may not be sufficient, in some circumstances, to meet urgent needs.” 

Due to increased demand and supply interruptions stemming from the ongoing pandemic, many hospitals have been experiencing difficulties in accessing FDA-approved drug products needed to treat patients infected with COVID-19. These drugs are vital to treat hospitalized COVID-19 patients, who have, for example, been intubated or need the medications in connection with other treatment procedures. In an effort to alleviate drug shortages, the U.S. Food and Drug Administration (FDA) has issued a new Final Guidance outlining proactive steps the agency is taking to alleviate these drug shortages. 

The COVID-19 epidemic has led to a critical shortage in respiratory protective devices. An amendment to the Secretary of Health and Human Services’ declaration under the Public Readiness and Emergency Preparedness (PREP) Act, published today in the Federal Register, may promote and expedite the production and use of such devices by allowing them to automatically be considered “Covered Countermeasures” for the purposes of PREP Act immunity.

On April 8, 2020, Massachusetts Governor Charlie Baker exercised his powers as an “Authority Having Jurisdiction” to issue a directive designating specific activities to which Public Readiness and Emergency Preparedness (“PREP”) Act immunity will apply in Massachusetts. The PREP Act provides expansive immunity from liability for claims of loss related to designated “Covered Countermeasures,” and was recently activated with respect to medical countermeasures against COVID-19 pursuant to a declaration issued by the Secretary of the Department of Health and Human Services.  However, certain restrictions apply, and there is little precedent to provide guidance as to how PREP Act immunity may attach in practice.

In response to the growing ventilator shortage caused by COVID-19, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) encompassing ventilators, anesthesia gas machines modified for use as ventilators, positive pressure breathing devices modified for use as ventilators, ventilator tubing connectors, and ventilator accessories (see 21 CFR 868). Product manufacturers that seek to be included in the EUA must submit a request to FDA and obtain approval prior to distribution. The ventilators, ventilator tubing connectors, and ventilator accessories that are eligible for inclusion under the EUA are:

In response to the current public health crisis causing medical equipment shortages, on April 3, 2020, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) permitting the importation of non-NIOSH approved filtering face-piece respirators (FFRs) manufactured in China, including KN95 masks. In its original EUA from March 28, FDA had authorized importation of similar respirators from six other countries, but China was excluded, despite the Centers for Disease Control and Prevention’s (CDC’s) statement that KN95 masks are “expected to be suitable alternatives to provide protection during the COVID-19 response while supplies are short.” FDA’s new EUA aligns with the CDC’s recommendation. 

Everyone wants to help by providing necessary equipment to the COVID-19 frontline: hospitals, doctors, nurses, and other healthcare providers battling COVID-19 need ventilators, masks, gowns and other supplies.

With the rapid spread of COVID-19, federal, state and local governments have been scrambling to ensure that the country is equipped with adequate resources to help mitigate the spread of the virus and treat those who have fallen ill. The Public Readiness and Emergency Preparedness Act (PREP Act) was enacted in 2005 and serves as a means of incentivizing contributions of much-needed resources in such times of crisis. The PREP Act authorizes the Secretary of the Department of Health and Human Services to issue a Declaration immunizing individuals and entities from liability associated with the use of medical countermeasures. Specifically, “Covered Persons” cannot be held liable for any claim of loss “caused by, arising out of, relating to, or resulting from” the development, testing, manufacture, distribution, administration, or use of designated “Covered Countermeasures” within the Secretary’s specified period of emergency.