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FDA’s Evolving Response to the COVID-19 (Coronavirus) Outbreak

Within the U.S. Department of Health and Human Services (HHS), many agencies have responsibility for responding to public health emergencies. The Centers for Disease Control and Prevention (CDC), as its name implies, is at the forefront of the COVID-19 (coronavirus) outbreak as the government seeks to control and prevent the spread of the virus in the United States. The National Institutes of Health (NIH), particularly the National Institute of Allergy and Infectious Diseases, are also involved, primarily conducting research into the sources, cause, and means of transmission of the new virus and coordinating vaccine development efforts. The Food and Drug Administration (FDA) is responsible for assuring the safety and effectiveness of medical products and therefore has oversight over any clinical trials for promising coronavirus treatments (drugs, vaccines, devices), as well as authority to authorize the marketing of any such product.

FDA Is Monitoring Medical Product Shortages

FDA's role in responding to a public health emergency like the one we’re currently experiencing is broader than clinical trial oversight and product approval. The agency oversees the drug supply chain and monitors drug and device shortages. FDA recently announced the first coronavirus-related drug shortage. Federal law requires drug manufacturers to notify FDA when they become aware of a circumstance that could lead to a potential shortage and FDA maintains a list on its website of drugs in shortage. FDA has a few levers to mitigate drug shortages or potential drug shortages, including extending expiration dates and expediting review of alternative therapies, although many stakeholders consider the agency’s role to be too minimal and in need of additional attention from Congress.

Unlike drugs, however, there is no statutory requirement for device manufacturers to notify FDA of potential or actual shortages. This makes it difficult for FDA to have a clear and up-to-date picture of device shortages and therefore makes it much more difficult for the agency to take steps to mitigate such shortages. FDA is not satisfied with this status quo, though. The agency’s FY2021 budget request to Congress includes a proposal to allow FDA to require device manufacturers to notify the agency of potential shortages, to require device manufacturers to periodically update the agency about the manufacturing capacity of “essential devices” (a term to be defined), and to authorize importation of unapproved/uncleared devices if doing so could help mitigate a shortage and the benefits of such devices outweigh the risks.

In the agency’s February 27, 2020, supply chain update related to COVID-19, FDA Commissioner Stephen Hahn, who is a member of the White House Coronavirus Task Force, reiterated the importance of this recent request to the public, adding, “Enabling the FDA to have timely and accurate information about likely or confirmed national shortages of essential devices would allow the agency to take steps to promote the continued availability of devices of public health importance.”

Although having such information is critical to the agency’s work and to the protection of public health, the device supply chain is more complex than the drug supply chain. Drug ingredients are typically manufactured at one or just a few facilities, whereas devices often have components manufactured in dozens of facilities. As a result, device companies have indicated that it would be extremely burdensome to satisfy FDA's desired mandates, potentially requiring them to divert resources from research and development and manufacturing. It is yet to be seen whether, in light of the current coronavirus situation, these issues are compelling counterarguments to the FDA’s policy position. Senator Josh Hawley (R-MO), who sits on the Homeland Security and Governmental Affairs Committee, has expressed interest in drug and device shortages in light of the coronavirus outbreak and could be an ally of the agency in enacting the desired authorities. Further, Representatives Schakowsky, Hice, and Schneider introduced a bill that aligns with FDA’s request for more authorities related to device shortages. These new authorities could be incorporated into the FY2021 spending bill or other health care legislation​ pending for 2020.

In the meantime, FDA is exercising its authority in creative ways to address potential supply chain disruptions and shortages. FDA and CDC recently announced that certain respirators—including N95 respirators—that are regulated by CDC, but not by FDA, can be used in health care settings in an effort to maximize the number of respirators available. (A respirator may be regulated by CDC’s National Institute for Occupational Safety and Health (NIOSH) and not FDA if the manufacturer does not make claims about its use related to health care.)

Immediately-in-Effect Policy Issued for Clinical Labs

In addition to its role in monitoring the supply chain and attempting to mitigate the adverse effects of a drug or device shortage, FDA oversees the development and approval of diagnostic products and test kits. On February 29, 2020, the agency announced that it was issuing a policy for COVID-19 molecular diagnostics tests developed and used in laboratories certified to perform high-complexity testing under the Clinical Laboratory Improvement Amendments (CLIA) prior to issuance of any emergency use authorizations (EUA) for such tests. A test kit developed by the CDC was granted an EUA on February 4, 2020, following the HHS declaration of a public health emergency; that CDC-developed test is what has been (or soon will be) distributed to public health agencies throughout the country.

FDA’s policy was effective immediately and enables laboratories to use any COVID-19 tests that they develop more quickly, with the goal of achieving more rapid testing capacity in the United States. It describes the circumstances under which FDA does not intend to object to the use of newly developed diagnostics for clinical testing while the laboratories that developed them pursue EUAs from the agency. Commissioner Hahn noted in the announcement that the agency “believe[s] this policy strikes the right balance during this public health emergency” and that FDA “will continue to help to ensure sound science prior to clinical testing and follow-up with the critical independent review from the FDA, while quickly expanding testing capabilities in the U.S. We are not changing our standards for issuing Emergency Use Authorizations. This action today reflects our public health commitment to addressing critical public health needs and rapidly responding and adapting to this dynamic and evolving situation.”

The balance between access to novel medical technology and appropriate regulatory oversight is not static. It is interesting to consider the agency’s encouragement of new laboratory developed tests (LDTs) in the context of responding to a public health emergency juxtaposed with the agency’s longstanding position that LDTs should be subject to more oversight. Congress is likely to consider the current experience with COVID-19 as it looks to act on the long-awaited Verifying Accurate and Leading-Edge IVCT Development (VALID) Act that was targeted to be introduced this month, based on the latest information we heard before the coronavirus situation began.

Lastly, while it can be difficult to think about long-term solutions in any emergency (including a public health emergency), we believe that some of the ideas being discussed would be good topics for a Collaborative Community. In particular, how to deal with device shortages, improving availability of diagnostics and assuring their validity, and how best to encourage and deliver new treatments (particularly during a crisis) may be appropriate issues for a multi-stakeholder, multi-perspective effort like a Collaborative Community to consider.

We will continue to monitor the federal response to coronavirus from a variety of legal and regulatory angles.

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Joanne counsels global clients on the regulatory and distribution-related implications when bringing a new FDA-regulated product to market and how to ensure continued compliance after a product is commercialized.