The pandemic caused by COVID-19 has already stretched resources for hospitals desperately thin, and these resource limitations only continue to grow.
For example, there has been a dramatic increase in demand for products that are specifically needed by patients with COVID-19, including ventilators and COVID-19 diagnostic tests. There has also been increased demand for products that can lower infection rates and maintain sterile health care conditions, such as hand sanitizer and personal protective equipment (PPE) such as surgical masks and gowns.
Dr. Craig R. Smith, chair of the Department of Surgery at New York-Presbyterian, stated in a memo to his colleagues that the hospital normally uses 4,000 non-N95 face masks per day but were using 40,000 such masks. He estimates that mask consumption will reach 70,000 per day at the highest levels of use projected.
This spike in demand and the cries of help from health care professionals has prompted both private industry and individuals to act. For example, Ford stated it was working with 3M to manufacture ventilators. In addition to the efforts of private industry, volunteer groups have also tried to fill the gap in supply through their own efforts by, for example, making homemade surgical masks and donating them to hospitals.
While these efforts are inspiring, many wonder whether there are legal impediments to helping produce these products or whether certain help is counterproductive and not welcomed by medical professionals and public health professionals.
This article will discuss how people can help in the current situation and the issues they should be aware of before volunteering.
General Issues of Concern
Although companies and individuals want to help fight the spread of COVID-19 by producing and providing certain health care products, they should still be mindful of the following issues.
Manufacturing Quality – New companies entering the market to create sophisticated products should make sure they have a basic understanding of manufacturing quality standards for such products and the harms that can result by failing to maintain such standards. Products regulated by the U.S Food and Drug Administration (FDA or the Agency) are usually required to be manufactured in accordance with the FDA’s Current Good Manufacturing Practice regulations (CGMPs) (e.g., drugs, dietary supplements) or Quality System Regulations (QSRs) (e.g., devices). Although the FDA may not have the time or resources during this pandemic to conduct oversight of new ad hoc manufacturing facilities to ensure proper compliance with CGMPs or QSRs, manufacturers should nevertheless have a basic understanding of manufacturing controls to ensure that the produced products are not unsanitary or defective. In certain situations, the FDA will also consider waiving some of these requirements to meet the emergent need. We would advise reaching out to outside consultants for information on how best to produce these products under the current circumstances. For example, Regulatory and Quality Consulting Solutions (R&Q), which helped author this article and whose contact information is listed at the end of this article, can help provide information regarding how to ensure quality production and distribution of medical devices, including PPE.
FDA – As discussed below, the FDA is allowing certain products that would normally be considered violative to be marketed under the current emergency situation. You should consult the FDA’s Emergency Use Authorizations (EUA) and guidance to determine how the Agency intends to deal with each product you are intending to produce.
Additionally, you should consider reaching out to the FDA if you think the Agency should allow certain other products to be manufactured and distributed that they are not currently already allowing. The FDA is trying to ensure that help is provided in a way that is both safe and useful. The Agency views itself primarily as an institution to help the public health, and it can be a very useful ally in the effort to get needed products to health care professionals. Already, they have shown great flexibility in their enforcement discretion in an effort to speed up the delivery of essential products to the needy.
Misrepresentations – Even if the FDA is allowing you to produce your product under an EUA or enforcement discretion, it is critical that you do not misrepresent to users what it is that you are offering. For example, if your mask is not an N95 FDA-cleared surgical respirator, do not claim it to be. You could not only face possible liability for misleading consumers about the nature of your product, but you could also cause serious harm to the public health if professionals rely upon your product and it fails to provide them the protection they need.
Fraud – Unfortunately, desperate situations bring out unscrupulous charlatans that sell products that take advantage of people’s fears. Already, our firm has seen and heard about companies being approached by scammers with fraudulent 510(k) clearance documents and companies being approached by sellers that misrepresent a product’s FDA-approval status. It is important when working with any new party in this area that you exercise due diligence to verify that the party you are dealing with is legitimate and that they are truthful about the nature of their product. Remember, the FDA maintains publicly accessible, searchable databases for legitimate companies’ products and manufacturing facilities on its website that you can utilize when you need to confirm someone’s statements regarding product or establishment registration status.
Safety – Even if you decide to manufacture therapeutic products solely out of a desire to help others, you may still be held liable if you behave in a negligent manner and your actions result in injury to others. For example, making unsanitary hand soap could cause infections, as well as increase the spread of COVID-19 and expose you to liability for the harm you cause. While it is true that operating under an EUA from the FDA can protect you from some tort liability, you still want to make sure that you have taken reasonable and necessary efforts to ensure the safety of the products you are intending to distribute. If you are new to manufacturing these FDA-regulated products, then ideally you would consult with experts that can advise prior to manufacturing and distributing your drug products.
Reimbursement – While the FDA is currently exercising its enforcement discretion and allowing certain therapeutic products to enter the market, this does not mean that these products will necessarily be eligible for payment and reimbursement. Representing that your product is eligible for reimbursement from private and/or public payors when it is not could expose you to liability as well.
There are several items that are currently in extreme demand and that individuals are volunteering to manufacture. We will discuss each below.
- Why they are needed – One of the biggest risks with COVID-19 is that the disease will cause respiratory failure in patients resulting in death. Ventilators help mitigate this risk by providing support for the lungs so that the body can take in oxygen and expel carbon dioxide. Currently, there are not enough ventilators to meet all the expected demand. For example, New York Governor Andrew Cuomo previously stated that they anticipate needing 30,000 additional ventilators to deal with the influx of patients with COVID-19.
- How they are usually regulated – Ventilators are generally regulated as Class II medical devices by the FDA under regulations 21 C.F.R. §§ 868.5895, 868.5925, 868.5160, 868.5905 and 868.5454. As such, ventilators would normally require a 510(k) or a Pre-Market Approval (PMA) from the FDA before they can legally be marketed.
- How people can help – Volunteers can (1) help companies scale up manufacturing and shipping of FDA-cleared ventilators; (2) help hospitals procure already FDA-cleared ventilators; (3) help import FDA-cleared ventilators; (4) help to make limited modifications to FDA-cleared ventilators to support patients with respiratory failure pursuant to the FDA’s guidance on enforcement policy for ventilators; or (5) help manufacture new FDA ventilators that are not FDA-cleared but that operate under the FDA’s new guidance on enforcement policy for ventilators.
- Emergency Use Authorizations or other exceptions – As stated above, the FDA has issued a guidance document on its enforcement policy for ventilators. This policy allows for limited modification to FDA-cleared ventilators, allows FDA-cleared ventilators to be used for different indications, allows FDA-cleared ventilators to be used past expiration dating and allows for new manufacturing of ventilators that are not FDA-cleared but that operate under the FDA’s new guidance on enforcement policy for ventilators in certain circumstances. People should review this guidance document if they intend to assist in this area. If someone wants to manufacture new ventilators that will not be first FDA cleared, they should review the FDA’s guidance document on ventilators and contact the FDA at CDRH-COVID19-Ventilators@fda.hhs.gov with the information requested in the guidance.
COVID-19 Diagnostic Tests
- Why they are needed – In order to control the spread of COVID-19, many public health professionals believe that we need to engage in larger-scale testing to better understand who is infected so as to ensure a more targeted quarantine.
- How they are usually regulated – These type of diagnostic tests are usually regulated as in vitro diagnostics medical devices or Laboratory Developed Tests (LDTs). LDTs generally require less FDA oversight than other medical devices, but they must be conducted in a laboratory that has been certified under the Clinical Laboratory Improvement Amendments (CLIA).
- How people can help – Volunteers can (1) help companies scale up manufacturing and shipping of testing kits and testing swabs, and (2) help create COVID-19 tests at CLIA-certified laboratories.
- Emergency Use Authorizations or other exceptions – The FDA has issued a new policy for diagnostic tests. Under this new policy, you can sell a diagnostic COVID-19 laboratory test if the FDA approves your EUA request for such a test or if you have developed a test under the authority of the State where the CLIA-certified laboratory resides and the State takes responsibility for the laboratory testing. Additionally, under this policy, in some instances serological tests (i.e., only testing for presence of IgG/IgM) may be distributed with first obtaining an EUA. If you have alternative technological approaches that could utilize quick results, the FDA asks that you reach out to the Center for Devices and Radiological Health (CDRH) at CDRH-EUATemplates@FDA.HHS.GOV.
- Why they are needed – In order to ensure that health care professionals and patients maintain good hygiene to prevent the spread of COVID-19, it is imperative that health care professionals and the public wash their hands frequently and thoroughly. This increased demand for washing has resulted in a need for more hand sanitizer.
- How they are usually regulated – Hand sanitizers are regulated as drug products since they claim to cure or mitigate a disease. Most hand sanitizers are manufactured under the Tentative Final Monograph for Health-Care Antiseptic Products under proposed 21 CFR Parts 333 and 369.
- How people can help – Volunteers can (1) help manufacturers scale up existing production of hand sanitizer. They can also help create new production of hand sanitizer under the FDA’s new policies allowing non-drug companies to make hand sanitizer as long as they follow the FDA’s current guidance requirements for manufacturing and labeling, register as OTC drug establishments and list their products with the FDA. Pharmacists and State-licensed pharmacies are also allowed to compound hand sanitizer under the FDA’s new guidance.
- Emergency Use Authorizations or other exceptions – As discussed above, the FDA has a new enforcement policy that allows companies to make hand sanitizer for their own use or for public distribution as long as they follow the FDA’s current guidance requirements for how to manufacture and label the product, as well as register their establishments and list their products with FDA. Additionally, companies that make such products should have a way to accept adverse event reports regarding their product. The FDA also has a separate policy that allows pharmacists and State-licensed pharmacies to compound hand sanitizer in certain circumstances.
- Why they are needed – Respirators are personal protective devices that are worn on the face to reduce the wearer’s risk of inhaling small hazardous airborne substances. Unlike regular masks, respirators are able to filter very small particles including bacteria and viruses
- How they are regulated – These products are regulated as class II medical devices under 21 C.F.R. § 878.4040, 880.6260, and National Institute for Occupational Safety and Health (NIOSH) under 42 CFR Part 84.
- How people can help – Volunteers can: (1) help import FDA-cleared respirators; (2) import respirators that have not been FDA or NIOSH-approved but are listed under CDC’s Strategies for optimizing the Supply of N95 Respirators: Crisis/Alternate Strategies; (3) help import other related face-piece respirators (FFRs) approved by the NIOSH that the FDA is allowing to be used as a substitute for FDA-cleared respirators at this time; (4) help people use respirator models that passed the recommended shelf life; and (5) help decontaminate respirators so they can be used.
- Emergency Use Authorizations or other exceptions – The FDA has issued an EUA for (1) respirators that have not been FDA-cleared have meet certain foreign standards and/or have obtain marketing authorization from certain regulatory jurisdictions; (2) FFRs approved by NIOSH that FDA is allowing to be used as a substitute for FDA-cleared respirators at this time; (4) respirator models that passed the recommended shelf life; and (5) decontaminated respirators. You can reach out to the FDA regarding importing these products at COVID19FDAIMPORTINQUIRIES@fda.hhs.gov.
- Why they are needed – Surgical masks help to provide a barrier against large particles that may contain germs. They can help prevent people from infecting others if they are sick, as well as protect those that that are well from inhaling large particles that could have germs attached. These products are not as effective as respirators for filtering out small particles but they are still needed in health care settings to help reduce the chance of infected individuals spreading COVID-19. They are also being used by food service personnel in nursing homes and other high-risk environments.
- How they are regulated – Surgical masks are regulated as medical devices under 21 C.F.R. 878.4040.
- How people can help – Volunteers can (1) help import FDA-cleared surgical masks, (2) help find surgical masks beyond the manufactured shelf life for use in certain situations, (3) help gather protective clothing based on NIOSH and OSHA standards in crisis situations where no cleared surgical masks are available, (4) create homemade masks in accordance with CDC’s recommendations for crisis situations where there are no masks available (but note that these masks are not considered PPE since their ability to protect healthcare professionals is unknown); and (5) help import certain “face masks” that could be useful to healthcare professionals. The FDA has issued guidance on how to label “face masks” that may not meet the requirements or have the testing to be labeled a surgical mask and yet may be used in shortage situations.
- Emergency Use Authorizations or other exceptions – The FDA does not have an EUA for surgical masks but does recognize that you may use other protective clothing based on NIOSH and OSHA standards in crisis situations where no cleared surgical masks are available. The FDA also has issued guidance on how certain “face masks” that may not meet the requirements or have the testing to be labeled a surgical mask and yet may be used in shortage situations. Additionally, the Center for Disease Control and Prevention (CDC) recognizes that homemade masks can be used in accordance with CDC’s recommendations for crisis situations where there are no masks available and labeled in accordance with FDA guidance. If you have masks to import, you can reach out to the FDA at COVID19FDAIMPORTINQUIRIES@fda.hhs.gov.
- Why they are needed – Surgical gowns help to reduce the spread of infections by protecting the wearer from germs that could get on their body.
- How they are regulated – Surgical gowns are regulated as medical devices under 21 C.F.R. § 878.4040
- How people can help – Volunteers can (1) help import FDA-cleared surgical gowns, (2) help find surgical gowns beyond the manufactured shelf life for use in certain situations, (3) help gather protective clothing based on NIOSH and OSHA standards in crisis situations where no cleared surgical gowns are available, (4) help repair reusable gowns in accordance with CDC recommendations on cloth isolation gowns, and (5) help create or donate homemade clothing made in accordance with CDC’s recommendations for crisis situations where there are no gowns available (but again note that these gowns are not considered PPE since their ability to protect healthcare professionals is unknown).
- Emergency Use Authorization or other exceptions – The FDA does not have an EUA for surgical gowns and recognizes that you may use other protective clothing based on NIOSH and OSHA standards in crisis situations where no cleared surgical gowns are available. Additionally, the CDC recognizes that you can use homemade gowns in accordance with the CDC’s recommendations for crisis situations where there are no gowns available (but these masks are not considered PPE since their ability to protect healthcare professionals is unknown). If you have gowns to import, you can reach out to the FDA at COVID19FDAIMPORTINQUIRIES@fda.hhs.gov on this.
Outside Contributor: Nancy Morrison, Executive Director, Regulatory & Quality Consulting Services
For more cutting-edge perspectives on the legal and business implications of COVID-19, visit our COVID-19 resource center.
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