The U.S. Food and Drug Administration (FDA) has issued several final guidance documents to assist manufacturers developing medical products in response to the coronavirus (COVID-19) pandemic. While some are published as "draft guidance," according to an announcement to be published in the Federal Register on March 25, 2020, all FDA draft guidance related to the COVID-19 response will be treated as final and thus go into effect without public comment.
While there are frequent statements in the media regarding the regulatory status – or potential regulatory status – of different products, to reduce regulatory risk, manufacturers should note what specific policies and recommendations the FDA has made in its published guidance. Manufacturers should also be aware that these guidances apply to the current public health situation only. In addition, the environment is fluid with FDA issuing new policies regularly. We have provided a high-level summary of five topics and products that the FDA has addressed in recent guidance below.
The FDA has released two guidance documents relating to alcohol-based hand sanitizer: allowing pharmacy compounding and manufacturing requirements. The regulatory status of the active ingredients in hand sanitizers has been in flux for several years under FDA's current over-the-counter (OTC) framework, and during the COVID-19 pandemic, there have been reports of shortages. According to the FDA, these guidances are designed to increase general supply (note that they apply to certain alcohol-based hand sanitizers only). In the compounding guidance, the FDA states it will not interfere with the production of alcohol-based hand sanitizers so long as they are for consumer and healthcare personnel use. Pharmacists in state-licensed pharmacies, federal facilities or registered outsourcing facilities are temporarily permitted to compound certain alcohol-based hand sanitizers. The guidance specifies what ingredients must be used.
The manufacturing guidance is designed for firms that do not typically produce hand sanitizer. It details requirements such as 1) the firm must only use alcohol as the active ingredient; 2) it must register with the FDA as a drug establishment; 3) it must label the product accurately and properly under FDA regulations; and 4) it must use an "accurate method of analysis" available at the manufacturing site to verify the alcohol content in samples of the finished drug product before each batch is released for distribution. Hand sanitizer firms will also be required to report adverse events for any products they manufacture and submit those reports to FDA.
The FDA has taken steps to increase the supply of ventilators. The new March 22 ventilator guidance lays out potential steps to provide manufacturers with the flexibility to modify existing ventilators and produce new ventilators. Under the guidance, current ventilator manufactures are permitted to modify existing devices without prior submission of a premarket notification if the modification will not create an undue safety risk. In addition, the agency encourages hospitals and other healthcare providers to repurpose their machines to treat patients in the event of a shortage of the cleared device, e.g., using ventilators outside their cleared environment of use (for example, use of a ventilator in a healthcare facility when it is only cleared for use at home or during transport).
In this guidance, the FDA also outlines the steps for Emergency Use Authorization (EUA) for ventilators developed by manufacturers of such devices that are not currently legally marketed in the U.S. as well as manufacturers who have not previously been engaged in medical device manufacturing. Specifically, for ventilator manufacturers whose product are not currently marketed in the US, the FDA wants to know the product's regulatory status in other countries as well as if the product is manufactured in compliance with Good Manufacturing Practices (GMPs). For manufacturers who have not previously been engaged in medical device manufacturing but who have capabilities to manufacture the devices, the FDA encourages immediate outreach, so the agency can collaboratively work with these manufacturers.
On Feb. 29, 2020, the FDA issued guidance authorizing Clinical Laboratory Improvement Amendments (CLIA)-certified labs to immediately use COVID-19 tests they have developed and validated, as we wrote about here. Note that as of this writing, the FDA has used its EUA to allow marketing of diagnostic tests in very limited circumstances. The agency expanded these policies in an updated guidance issued on March 16, 2020. In this updated guidance, the FDA grants individual states permission to approve tests based on their own testing procedures as long as the lab operates within the state. These labs will not need to pursue approval from the FDA but rather only from their respective state authorities. The updated guidance further clarifies that commercial manufacturers are covered by the Feb. 29 guidance, and labs may use new commercially developed tests prior to the FDA granting an EUA under certain circumstances. Lastly, the updated guidance provides recommendations for test developers who may wish to develop serological tests for use during the COVID-19 pandemic.
In this guidance, the FDA acknowledges that the COVID-19 pandemic raises questions and concerns about the conduct of clinical trials – those underway as well as those planned. As outlined in the clinical trial guidance issued on March 18, 2020, the FDA details recommendations for clinical trial sponsors, investigators and institutional review boards (IRBs) to protect patient safety while streamlining clinical trial processes as appropriate. The guidance provides options for ongoing clinical trials, including use of "virtual visits" and additional safety monitoring rather than in-person or in-office follow-up visits. Moreover, the agency recognizes that protocol changes may need to occur quickly to minimize or eliminate immediate hazards or to protect the life and well-being of research participants. Consequently, the agency will allow these changes to a research protocol without IRB approval so long as the IRB is notified. FDA encourages sponsors and investigators to work with their IRBs to prospectively define procedures to prioritize reporting of deviations that may impact the safety of trial participants.
The FDA has expressed its concern that the need for personal protective equipment (PPE) may outpace supply during the COVID-19 pandemic. FDA issued an EUA for PPE on March 2 for emergency use of disposable filtering facepiece respirators. Moreover, the FDA has invited manufacturers of surgical masks and surgical and isolation gowns to contact the agency if they can help alleviate supply pressures.
FDA's COVID-19 policy is fluid, and FDA's policies are changing rapidly. We are actively monitoring the agency's actions and are available to answer any questions.
DISCLAIMER: Please note that the situation surrounding COVID-19 is evolving and that the subject matter discussed in these publications may change on a daily basis. Please contact the author or your responsible Holland & Knight lawyer for timely advice.
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