Many global markets have been impacted by COVID-19, including the medical product and food industries. Both sectors are particularly critical as medical products are relied upon to help abate the disease and as communities are being directed to quarantine and shelter in place, ready access to safe food is becoming increasingly important. The U.S. Food and Drug Administration (FDA) is a public health agency that maintains regulatory oversight of both industries. In response to the pandemic, the FDA has announced numerous initiatives to help mitigate the actual and potential effects of the virus on industry and the public. Below is a digest of certain recent FDA regulatory policies developed to address the business and population threat of COVID-19. Wilson Sonsini intends to update the digest as more information becomes available.

• March 18 - FDA Focuses on Safety of Regulated Products While Scaling Back Domestic Inspections: The FDA announces that it has temporarily postponed all domestic routine surveillance facility inspections. These are facility inspections the FDA traditionally conducts every few years based on a risk analysis. Importantly, all domestic for-cause inspection assignments will be evaluated and will proceed if mission-critical. The FDA is evaluating additional ways to conduct for-cause inspections including, among other things, evaluating records in lieu of conducting an onsite inspection. Earlier in the month, the FDA postponed most foreign inspections through April 2020.
• March 18 - FDA Issues Guidance for Conducting Clinical Trials: The FDA issued a guidance for industry, investigators, and institutional review boards conducting clinical trials during the COVID-19 pandemic. The guidance outlines considerations to assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice and minimizing risks to trial integrity. Considerations recommended include, among others, sponsors evaluating alternative methods for assessments, like phone contacts or virtual visits and offering additional safety monitoring for those trial participants who may no longer have access to investigational product or the investigational site. Wilson Sonsini has issued a separate alert specifically on this announcement.
• March 17 - FDA Issues Temporary Policy for FSMA Onsite Audit Requirements: To help prevent disruptions in the food supply-chain during the COVID-19 pandemic, the FDA issued a temporary policy for Food Safety Modernization Act (FSMA) supplier verification onsite audit requirements. The policy states that the FDA will temporarily not enforce FSMA supplier verification onsite audit requirements if other appropriate supplier verification methods are used instead. Other supplier verification methods, such as sampling and testing or a review of food safety records, would be designed to provide sufficient assurance that hazards have been significantly minimized or prevented during the period of onsite audit delay.
• March 16 - FDA Provides More Regulatory Relief During Outbreak, Continues to Help Expedite Availability of Diagnostics: The FDA issued a guidance to foster diagnostic development considering the urgent need caused by COVID-19. The guidance provides recommendations for test developers who wish to develop serological tests; puts forth a policy for states to take responsibility for tests developed and used by laboratories in their states; and announces enforcement discretion towards commercial manufacturers distributing and labs using new commercially developed tests prior to the FDA granting an emergency use authorization, under certain circumstances. Wilson Sonsini has issued a separate alert specifically on this announcement.
• March 9 - FDA and FTC Warn Seven Companies Selling Fraudulent Products that Claim to Treat or Prevent COVID-19: The FDA and the Federal Trade Commission (FTC) issued warning letters to seven companies for selling fraudulent COVID-19 products. The products were considered unapproved drugs that pose significant risks to patient health and violate federal law. Rather than affording the usual 15 days for company responses, the warning letters requested companies respond in 48 hours describing the specific steps they have taken to correct the violations. Wilson Sonsini has issued a separate alert specifically on this announcement.
• February 27 - Supply Chain Update: The FDA announced initiatives to help curb potential disruptions to supply or shortages of medical products in the U.S. Certain manufacturers of medical products have been asked to evaluate their supply chain as communicating potential disruptions can help work with companies to help identify interventions to mitigate potential shortages. The announcement also advocated four specific proposals included in the President's budget that the FDA belies help prevent or mitigate medical product shortages: lengthen expiration dates to mitigate critical human drug shortages, improve critical infrastructure by requiring risk management plans, improve critical infrastructure through improved data sharing and require more accurate supply chain information, and establish reporting requirements for device manufacturers.