The Daily Report is a compilation of COVID-19 (coronavirus) news briefs from around the world to help life sciences and health care companies stay current in this challenging time.

In Wednesday's report: REMS requirements for lab tests/imaging, harmonized EU clinical trial guidance, PREP Act liability immunity provisions, CDRH's letter to industry, ventilator supply moves, EUAs for serological tests, and FDA FAQs on diagnostic testing.

Wednesday, 25 March 2020

• On 22 March 2020, the U.S. Food and Drug Administration (FDA) published the guidance “Policy for Certain REMS Requirements During the COVID-19 Public Health Emergency,” in which the agency recognizes that completion of laboratory testing (e.g., liver enzyme testing) or imaging studies (e.g., magnetic resonance imaging) required by risk evaluation and mitigation strategies (REMS) may be difficult as patients may need to avoid public places and patients suspected of having COVID-19 may be self-isolating and/or subject to quarantine. Accordingly, the guidance says that during the novel coronavirus pandemic, under certain conditions, FDA does not intend to take action against drug sponsors for failing to adhere to REMS requirements for laboratory testing or imaging studies. Read more here: "FDA permits waivers of some REMS-required laboratory tests, imaging studies due to COVID-19" (Authored by Lynn Mehler)

• In addition to guidance issued by European Union (EU) Member States on the conduct of clinical trials during the COVID-19 pandemic, harmonized EU guidance has now been issued. On 20 March 2020, the European Commission, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) published new recommendations for sponsors and investigators on how to manage the conduct of clinical trials during the COVID-19 pandemic. Read more here: "EU Guidance to sponsors, investigators on how to manage clinical trials during the COVID-19 pandemic" (Authored by Hein van den Bos)

• The Secretary of HHS issued an emergency declaration, effective 4 February 2020, regarding COVID-19. The impact of that declaration is to trigger the liability immunity provisions under the Public Readiness and Emergency Preparedness Act (PREP Act). Under those provisions, qualified pandemic products are "immune from suit and liability under federal and state law” for all claims relating to the administration to or use for purposes of diagnosing, mitigating, preventing, treating, or curing COVID-19. Importantly, the liability immunity does not impact the United States’ right to bring suit, such as under the False Claims Act. The liability immunity applies to suits brought by parties other than the United States and only if (1) the device is cleared or exempt under the FDCA or (2) the device is authorized for emergency use under an EUA issued under the FDCA and there is not willful misconduct that caused death or serious physical injury. The PREP Act also sets a high bar for willful misconduct: the conduct must be intentionally to achieve a wrongful purpose, knowingly without legal or factual justification, and in disregard of a known or obvious risk that is so great as to make it highly probable that the harm will outweigh the benefit. If the willful misconduct involves regulated activity under the PREP Act, the action is permitted only if HHS or DOJ have initiated an enforcement action. The liability immunity extends only through the period in which the Declaration is in effect or 1 October 2024, whichever occurs first. Read more here. (Authored by Peter Spivack and Emily Lyons)

• While numerous entities are responding with impressive speed and diligence in working to develop and deploy various COVID-19 countermeasures, some from the Plaintiffs bar are already putting up online advertisements offering legal services to pursue product liability and other civil liability claims relating to Coronavirus care and treatments. One of the most critical and immediate needs at this time is expedited clinical trial testing to support potential COVID-19 prophylactics and treatments, but conducting a clinical trial on an accelerated timetable is not without risks and no company engaging in these potentially life-saving clinical activities wants to become the subject of a product liability lawsuit down the road. To address liability considerations, on March 10, 2020, the Secretary of the Department of Health and Human Services (HHS) issued a declaration pursuant to the Public Readiness and Emergency Preparedness (PREP) Act granting tort immunity to entities involved in creating and distributing "countermeasures" to the COVID-19 virus. The Declaration is intended to foster the expeditious development of drugs and devices designed to prevent and treat COVID-19. Here’s what you need to know about the scope of the protections provided by the COVID-19 Declaration: "Navigating Limits on Product Liability under the PREP Act for COVID-19 Clinical Trial Activities." (Authored by Lauren Colton and Robert Church)

• On 24 March 2020, the FDA issued a letter to industry outlining the agency’s steps to address the impact of the COVID-19 public health emergency on day-to-day operations in the Center for Devices and Radiological Health (CDRH) and in the medical device industry. The agency indicated that

  • teleconference meetings with industry will take place in lieu of in-person meetings through 30 April 2020.
  • response due date extensions of 60 days are automatically granted for marketing applications on hold as of 16 March 2020, where the due date is on or before 30 April. The extension applies to Premarket Notifications (510(k)s), Premarket Approvals (PMAs) (original and supplements), Humanitarian Device Exemption (HDEs) (original and supplements), and De Novo classification requests. Questions on response due dates should be directed to CDRHPremarketProgramOperations@fda.hhs.gov.
  • the Document Control Center continues to receive and process incoming documents. FDA is not able to accept email submissions and is investigating alternative electronic options.
  • Emergency Use Authorization (EUA) applicants are strongly encouraged to submit pre-EUAs to get feedback from the agency. For inquiries on EUAs for in vitro diagnostics contact CDRH-EUA-Templates@fda.hhs.gov; for non-IVD medical devices contact CDRH-NonDiagnosticEUA-Templates@fda.hhs.gov.

  • CDRH continues to process and work on mission critical post-market and compliance activities. (Authored by Ted Wilson)

• Amid reported shortages of ventilators, accessories, and other respiratory devices resulting from the spread of novel coronavirus COVID-19, FDA issued a letter to health care providers and new guidance on 22 March 2020, related to FDA’s policies intended to increase access to devices for providing respiratory support. The guidance provides leeway to manufacturers of breathing support devices to allow use of these products for broader indications and also suggests that Emergency Use Authorizations (EUAs) may be granted to allow ventilators which are not currently FDA-cleared into clinical care environments. Further, the guidance supports the EUA pathway for manufacturers who do not traditionally manufacture medical equipment but may be able to partner with ventilator companies to manufacture such devices. Read more here. (Authored by Michael Heyl)

• FDA continues to clarify its policies and associated practical requirements for COVID-19 diagnostic tests. The Agency’s March 16 “immediately in effect” guidance document loosened the requirements for distribution of certain tests in order to increase the availability of much-needed diagnostic tests in an effort to control the pandemic. In brief, the updated policy allows diagnostic tests to be distributed prior to obtaining an emergency use authorization (EUA), pursuant to (1) appropriate validation; (2) notification to FDA; (3) disclosure within the test report/results that the test has been validated but not yet reviewed by FDA; and (4) other applicable limitations and test-type-specific requirements as outlined in the guidance. Per direct correspondence with FDA, molecular-based tests will still require an EUA to get past customs, meaning that the policy is less beneficial for foreign manufacturers. However, Hogan Lovells has learned that serological tests (those that detect antibodies to the virus as opposed to the nucleic acid sequences of the virus itself) that meet the above expectations and limit their claims to antibody detection (i.e., are not marketed as the sole basis for informing infection status) will not require an EUA to enter the U.S.; they can do so based on FDA notification and manufacturer registration and listing of the test with FDA. (Authored by Suzanne Levy Friedman)

• On 23 March 2020, FDA updated the agency’s FAQs on Diagnostic Testing for SARS-CoV-2 at https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-diagnostic-testing-sars-cov-2, to expand the types of FDA-accepted specimen collection devices and specimen transport media used by testing laboratories. Of importance, due to limited supplies, FDA now recognizes alternative specimen collection devices for possible use in collection of samples from symptomatic individuals. Testing facilities also may now accept a symptomatic patient’s onsite, self-collected specimens, as well as alternative specimen transport media for their transportation and storage. The specific types of self-collection and alternative sample transport media are listed in the updated FAQs. However, we are still several steps away from FDA accepting “at home” testing for symptomatic and asymptomatic individuals; when available, such tools could enhance the tracking and self-quarantine of individuals to stop the spread of the coronavirus. Notably, the agency specifically stated that: Due to concerns with specimen stability, transport, and appropriate collection materials, self-collection at home or at sites other than designated collection sites staffed by HCPs is currently not recommended. FDA stated its goal is to work with diagnostic manufacturers to develop at home tests and we are hopeful that ultimately home testing will be a reality and assist with containing the spread of this current viral epidemic. (Authored by Susan Tiedy-Stevenson)

Tuesday, 24 March 2020

• FDA issued a revised guidance on postmarketing adverse event (AE) reporting for drugs, biologics, medical devices, combination products, and dietary supplements during the ongoing COVID-19 pandemic. While the agency advises that normal adverse event AE reporting processes should be maintained to the maximum extent possible, the guidance explains FDA’s intended approach for prioritizing enforcement of adverse event reporting requirements during a pandemic, allowing for delays in meeting reporting obligations in some instances. (Authored by Philip Katz and Lina Kontos)

• As the coronavirus (COVID-19) pandemic rapidly evolves, the United States faces unprecedented needs, which are quickly challenging existing supplies and disrupting supply chains. Having already declared a National Emergency, the Trump Administration has begun to activate emergency contracting measures that can be used to procure goods and services needed to fight the virus, including the Defense Production Act of 1950 (DPA) and the Public Readiness and Emergency Preparedness Act (PREP Act). (Authored by Michael J. Vernick)

• Poland declared emergency regulations in response to the COVID-19 epidemic on 20 March 2020. The Ministry of Health’s regulation implements tighter limitations in many areas and stipulates among other things: (1) a ban on exports of life-support machines and cardiac monitors outside Poland; (2) the obligation to notify about the intended export of personal protection equipment and disinfection products outside Poland; (3) easier access to online treatment by enabling identification of patients' health insurance online or via phone; (4) admissibility to make orders for certain reimbursable medical devices, including orthopedic products, with use of electronic systems. The state of emergency will continue until revoked. (Authored by Agnieszka Majka)

Monday, 23 March 2020

• Amid reported shortages of ventilators, accessories, and other respiratory devices, FDA issued new guidance on 22 March 2020 related to the agency’s intended enforcement policy for such products. While stressing that FDA hospitals should use ventilators that are FDA-cleared, where the number of available ventilators may not be sufficient, the agency suggests utilizing other devices which are FDA-cleared and are capable of delivering breath support. Further, FDA announced that it does not “intend to object” to modifying the indications, claims, or making minor modifications to the functionality, hardware, software, or materials of such products to support patients with respiratory failure or respiratory insufficiency, without prior submission of a 510(k) notice for the duration of the declared public health emergency. The Enforcement Policy guidance further appears to expand the availability of emergency use authorizations (EUAs) to new ventilator manufacturers. The guidance contemplates two scenarios: (1) ventilators which have previously been approved by other jurisdictions outside of the US, as well as manufacturers of new ventilators and (2) manufacturers who do not manufacture medical devices but are available to increase the supply of such products. This expanded pathway may allow for companies with ventilators not currently cleared by FDA to come to market quickly to meet increased demand and also commercial product manufacturers to produce ventilators. (Authored by Lina Kontos and Arthur Kim)

• While not an Emergency Use Authorization (EUA), FDA announced on 20 March 2020 explicit regulatory enforcement discretion in a “direct to final” guidance document to allow manufacturers and users of specific, already-cleared and legally marketed vital sign monitoring devices that can be used to monitor COVID-19 patients to allow the devices to be modified and/or used for remote monitoring. In sum, FDA will allow these previously uncleared uses or modifications to allow remote monitoring throughout the duration of the COVID-19 emergency. Specifically, “FDA does not intend to object to limited modifications to the indications, claims, functionality, or hardware or software of FDA-cleared non-invasive remote monitoring devices … during the declared public health emergency … without prior submission of a premarket notification…” This will allow devices cleared for hospital use to be used in homes and for devices that have wired connections to be modified for wireless connectivity. (Authored by Randy J. Prebula)

• FDA announced on 20 March 2020 emergency conservation strategies for medical gloves. This guidance highlights strategies that health care providers may wish to consider based on the supply needs of their health care organization. The recommendations address strategies to conserve gloves: (1) when supply levels are adequate (by using non-sterile gloves when feasible and reserving sterile gloves to cases where needed); (2) when supply is limited (by using products beyond their labeled expiration date): and (3) when medical gloves are running low or are not available (by using expired products, reducing changes between patients, or relying on alternative gloves, such as radiation safety gloves or food service gloves). (Authored by Randy J. Prebula)

• To help clinical laboratories and healthcare providers access and expand SARS-CoV-2 testing, FDA updated its FAQs on 20 March 2020 to provide lists of laboratories conducting testing, states granted authority to review and authorize laboratories to conduct testing, provided detailed lists of available sample collection systems, and listed alternative transportation/storage media that can be used when standard viral transport and storage media are in short supply. (Authored by Randy J. Prebula)

• The Belgian Federal Agency for Medicines and Health Products (AFMPS) released a series of guidance and recommendations over the last few days in relation to the COVID-19 outbreak. They cover important topics such as direct-to-patient dispensing of medicinal products in clinical trials, the Belgian Federal government's Task Force to remedy the shortage of medical protection equipment or measures to ensure continuity of treatment for patients suffering from chronic diseases. (Authored by EA Wright and Helene Boland)

• The Spanish Agency for Medicinal Products and Medical Devices (AEMPS), as the competent authority for authorizing clinical trials in Spain, published a series of recommendations to be applied exceptionally during the COVID-19 crisis in the following areas: (i) scheduled face-to-face visits, (ii) recruitment of new patients, (iii) access to trial treatment, (iv) monitoring visits; (v) transfer of patients from one site to another, and (vi) clinical trials aimed at researching new drugs against coronavirus. The drastic measures recently adopted by the Spanish government through the declaration of the state of emergency could compromise some actions in the framework for clinical trials. It is therefore important that sponsors, together with investigators, carry out a risk analysis and prioritize the activities that are critical and how they should be performed. Both should assess the application of these measures in a proportionate manner for each clinical trial, taking into account its particularities, the organization of each site, and the epidemiological characteristics of COVID-19 in that site. Any exceptional measures taken should be duly documented in the trial file. Although their application does not require, in principle, prior approval by the AEMPS nor the Ethics Committee, some of them may require to be notified. (Authored by Santiago Garrido and Álvaro Abad)

• Is the COVID-19 health crisis the telemedicine moment? The inherent value of telemedicine is readily apparent in the context of an acute public health challenge that is being addressed primarily by limiting face-to-face human interaction. From the beginning, telemedicine has offered convenient and prompt access to medical professionals via your laptop computer; now add to these attributes the ability to avoid risks presented by a full waiting room of other patients who may be shedding a viral load. Read our analysis in Forbes. (Authored by John Osborn)

*Compiled by Aaron Armstrong and Judy Rein

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