Overview
For additional guidance, please refer to Steptoe's COVID-19 Resource Center.
The US Food and Drug Administration (FDA) plays a vital role in the economy, with products it regulates accounting for approximately 20 cents of every dollar spent by US consumers. In these challenging times, FDA's role is even more important, as many of the products and entities it regulates are key players in the battle against COVID-19. Yet all industry players that are regulated by FDA are trying to deal with a host of unprecedented issues, including manufacturing, supply chain, and sales disruptions. This alert summarizes FDA's response as of March 23, to COVID-19, with an emphasis on the information the regulated industry needs to know as well as how you might be able to help. In particular, this alert discusses:
- Recent guidance from the federal government designating certain industries as "essential";
- FDA's announcements easing certain regulatory burdens for those in the food industry;
- The suspension of certain FDA facility inspections, both domestically and abroad;
- Unique opportunities for businesses to help FDA in the COVID-19 response.
Many FDA Regulated Industries have been Designated as "Essential" by the Government
On March 19, the Department of Homeland Security's Cybersecurity and Infrastructure Security Agency (CISA) released a guidance document declaring that certain industry sectors are essential to ensuring continuity of functions critical to public health and safety, as well as economic and national security. Although this guidance document was not drafted by FDA, it nevertheless is important for certain industries regulated by FDA because it lends support to the need for those sectors to continue operating throughout the duration of this crisis. The following FDA regulated sectors are mentioned in the CISA guidance document:
- Healthcare, which includes those manufacturing needed medical equipment, drugs, and workers tasked with conducting COVID-19 research;
- Food and agriculture, including employees of companies engaged in the production of chemicals, medicines, vaccines, and other substances used by the food and agriculture industry including pesticides, herbicides, fertilizers, minerals, enrichments, and other agricultural production aids;
- Chemical manufacturing, including workers supporting the chemical and industrial gas supply chains, chemical manufacturing plants, laboratories, distribution facilities, as well as workers who transport basic raw chemical materials to the producers of industrial and consumer goods including hand sanitizers, food and food additives, pharmaceuticals, textiles, and paper products.
The packaging industry is clearly designated in the guidance document as "essential," with nine separate references to the word packaging in the document. Those manufacturing food-contact materials, medical device packaging, and drug packaging obviously play an important role during the COVID-19 outbreak.
Steptoe and Johnson LLP already issued separate alerts discussing the impact of California’s "stay at home” order and the CISA guidance. See here and here.
FDA Facility Inspections Postponed
FDA announced that it has temporarily postponed most foreign facility inspections through April, and that inspections outside the US deemed mission-critical will be considered on a case-by-case basis as this outbreak continues to unfold. Domestic, routine facility surveillance inspections have been postponed, but all domestic for-cause inspection assignments will be evaluated and will proceed if deemed mission-critical.
FSMA Supplier Verification Onsite Audit Requirements Temporarily Relaxed
FDA announced on March 17 that it will temporarily not enforce requirements from the Food Safety Modernization Act (FSMA) that frequently lead to receiving facilities and importers conducting onsite audits of suppliers based on their hazard analysis activities, as described in the receiving facility or importer’s written food safety plans. FDA's announcement stipulates that other supplier verification activities must still be performed, based on what is appropriate and necessary under the circumstances. FDA's enforcement discretion announcement was issued in light of travel restrictions and advisories associated with COVID-19 that may make some audits temporarily impractical to conduct.
Special Opportunities for Industry to Help
FDA's current policies provide unique business opportunities that have the potential for significant public health protection.
Certain Drugs and Medical Devices Premarket Review Requirements Relaxed
FDA has issued a number of guidance documents and alerts related to the drug and medical device sector. On February 29 and March 16, FDA announced its intent to make it a top priority to expedite availability to access for diagnostic equipment, whether through Emergency Use Authorization (EUA) or other means. FDA subsequently announced on March 16 the issuance of EUAs for two COVID-19 tests and, just five days later, FDA announced it issued the first emergency use authorization for a point-of-care diagnostic test for COVID-19.
FDA also released a guidance document on March 22 intended to promote access and availability of critical ventilators. The ventilator guidance document clarifies that certain ventilator modifications may be acceptable absent a standard FDA review. Ventilators intended for environs outside hospitals or other certain health care settings may be used more widely or beyond their shelf-life, and manufacturers are encouraged to consult FDA via the EUA pathway to bring additional ventilators to market.
Hand Sanitizers
On March 20, the FDA released a guidance document declaring that, for the duration of the COVID-19 emergency, the agency does not intend to take action against manufacturing firms that prepare alcohol-based hand sanitizers for consumer use and for use in health care settings, regardless of whether the firm in question was already regulated by FDA as a drug manufacturer. These companies do need to follow the requirements in the guidance document, which sets forth specific formulation and labeling requirements, as well as register with FDA to begin selling hand sanitizer. FDA issued this guidance document in response to a number of queries from entities that are not currently licensed or registered drug manufacturers that would like to prepare alcohol-based hand sanitizers, either for public distribution or for their own internal use.
Companies that want to sell hand sanitizer containing alcohol also need to be mindful of applicable Tobacco Tax and Trade Bureau (TTB) requirements. Importantly, the TTB recently decided to waive certain legal requirements with regard to distilled spirits to provide limited exemptions and authorizations to existing distilled spirits permittees who wish to produce alcohol-based hand sanitizers to address the demand for such products during this emergency.
Steptoe and Johnson LLP will be authoring a more detailed summary of FDA and TTB efforts to increase hand sanitizer availability. Please stay tuned.
Steptoe and Johnson LLP's dedicated team of professionals in the Chemical and Life Sciences practice group is capable of assisting you on any pressing FDA or other related matters. We will continue to monitor FDA's activities and provide important updates.
