Efforts to increase testing are occurring at the national and state levels. The Food and Drug Administration (FDA) continues to crack down on firms marketing products – including drugs, testing kits and personal protective equipment (PPE) – with unproven claims. Increased oversight of emergency use authorizations is underway as more products receive temporary FDA authorization.

Health and Human Services

The Centers for Medicare and Medicaid Services (CMS) took steps to increase access to diagnostic testing and medical care. Medicare does not require an order from a treating physician or other practitioner in order for beneficiaries to get COVID-19 tests. During the public health emergency, COVID-19 tests may be covered when ordered by any healthcare professional authorized to do so under state law. Pharmacists continue to be increasingly utilized and recognized. When pharmacists work with a physician or other practitioner to provide assessment and specimen collection services, the physician or other practitioner can now bill Medicare for the services. Pharmacists also can perform certain COVID-19 tests if they are enrolled in Medicare as a laboratory. CMS recognized the need for beneficiaries to access COVID-19 tests at pharmacies because “such point-of-care sites are a key component in expanding COVID-19 testing capacity.”

CMS also expanded telehealth services so that Medicare beneficiaries can receive care in their homes without risking exposure to COVID-19. CMS added to the list additional practitioners, including physical therapists, occupational therapists and speech language pathologists, who may provide telehealth services. Additionally, CMS will add new services to the list of telehealth-eligible Medicare services based on requests by practitioners to speed up the process of adding new services.

FDA

The FDA issued guidance reminding the industry of the automatic exemption and exclusion from certain requirements of the Drug Supply Chain Security Act (DSCSA) during a public health emergency. The DSCSA establishes the framework for the identification and tracing of certain prescription drug distribution. Specific activities are automatically excluded from certain DSCSA requirements upon the declaration of a public health emergency. Specifically, the distribution of a product for emergency medical reasons is exempted from the definition of a transaction and excluded from the definition of wholesale distribution under the DSCSA. The FDA issued the guidance to “provide detailed information addressing the scope of the DSCSA public health emergency exemption and exclusion during the COVID-19 public health emergency and to clarify the types of distribution activities related to COVID-19 that fall under the transaction definition exemption and the wholesale distribution definition exclusion.” The FDA limits the exemptions and exclusions to only products and activities that are being distributed for emergency medical reasons.

FDA Warnings

To date, the FDA has issued more than 40 warning letters related to COVID-19. The FDA and the Federal Trade Commission (FTC) jointly issued the most recent warning letters to two companies for marketing COVID-19 treatments and homeopathic treatments. There is no FDA-approved treatment for or prevention of COVID-19. The FDA is aware of hundreds of such products – including drugs, testing kits and PPE – sold online with unproven claims. FDA warning letters have originated from the FDA’s review of websites, social media accounts and labels. After one seller refused to take the corrective action communicated in a warning letter, a federal court issued a preliminary injunction requiring the seller to immediately stop distributing its unproven and potentially dangerous product. Before marketing any product during this time, firms should carefully review the requirements found in the Food, Drug, and Cosmetic Act, specifically regarding new drug approval and misbranding provisions.

PPE

On May 7, the FDA revised the emergency use authorization (EUA) on imported non-National Institute for Occupational Safety and Health (NIOSH)-approved respirators manufactured in China, removing more than 60 respirator models from the list of authorized imported, non-NIOSH-approved respirators manufactured in China. Under the original EUA, manufacturers or importers could request that their product be added to the list of authorized products. Originally, the FDA outlined three conditions of eligibility for a disposable non-NIOSH-approved respirator manufactured in China: (1) It is manufactured by an entity that holds one or more NIOSH approvals for other models of filtering facepiece respirators produced in accordance with the applicable standards of authorization in other countries that can be verified by the FDA; (2) it has a regulatory authorization under a jurisdiction other than China that can be authenticated and verified by the FDA; or (3) it demonstrates acceptable performance to applicable testing standards as documented by test reports from a recognized independent test laboratory that can be verified by the FDA.

The FDA revised the EUA because it received testing data from NIOSH, which found that some of the respirators manufactured in China and authorized under the EUA did not meet the expected performance criteria of greater than or equal to 95 percent particulate efficiency. The FDA communicated this respirator failure in a letter to healthcare providers. In addition to removing many respirators from the authorized list, the FDA has made the following revisions to the EUA: (1) revised the eligibility criterion allowing authorization based on acceptable performance to standards documented by independent laboratory testing; (2) removed the ability of importers to apply for the EUA, and directed manufacturers to provide a list of authorized importers; and (3) added recognition of the Chinese National Medical Products Association registration certification that can be verified by the FDA. Firms currently importing respirators should perform due diligence to ensure the respirators comply with the EUA and are effective at particulate filtration before distributing them to the public and healthcare professionals. Moving forward, only manufacturers will be able to add respirators imported from China to the list of authorized respirators.

The FDA sent a letter to healthcare providers regarding the risk of misinterpreting hydrogen peroxide indicator colors for vapor sterilization. The FDA has issued several EUAs for the reprocessing and sterilization of medical devices, specifically N95 respirators, during COVID-19. Additionally, many healthcare facilities are pursuing in-house sterilization and reprocessing. Hydrogen peroxide vapor sterilization is a popular method of decontaminating disposable compatible N95 and N95-equivalent respirators for single-user reuse. Hydrogen peroxide vapor sterilization systems often use a color-coded indicator to indicate whether the material was decontaminated. The FDA warned healthcare providers that there is no standard color to indicate validated sterilization. Each manufacturer has developed its own color scheme to validate the sterilization process, and the colors vary among manufacturers even though many are validated for the same cycle conditions. If staff assume that all manufacturers use the same color code to validate sterilization, they mistakenly may release contaminated devices for reuse. The FDA is working with manufacturers of sterilization systems to improve product labeling and explore standardization for colors used to indicate sterilization. For facilities that are reprocessing medical devices, it is important to update policies and procedures to put systems in place to prevent releasing contaminated devices.

Diagnostics and Serological Tests

To provide the most accurate information regarding COVID-19 testing, the FDA continuously updates its FAQs on testing for SARS-CoV-2. On April 28, the FDA received a letter from the House Committee on Oversight and Reform pressing for compliance with the subcommittee’s investigation into the agency’s policies governing serological testing for COVID-19. Likely in response, the FDA issued the revised Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency. The release of the revised policy was followed by Insight into FDA’s Revised Policy on Antibody Tests: Prioritizing Access and Accuracy, authored by Anand Shah, M.D., deputy commissioner for Medical and Scientific Affairs, and Jeff Shuren, M.D., director, Center for Devices and Radiological Health. Under the revised policy, the FDA outlined several expectations for antibody test developers. First, commercial manufacturers are expected to submit EUA requests, with their validation data, within 10 business days of the date they notified the FDA of their validation testing. Second, the FDA provided specific performance threshold recommendations for specificity and sensitivity for all serology test developers. The FDA also streamlined the EUA submission process by making templates available. The FDA continues to detain and refuse importation of illegitimate test kits.

Advancements in detection time and at-home testing are coming to market. In late April, the FDA authorized the first diagnostic test with a home collection option for COVID-19. The test required a sample collected from the patient’s nose, using a designated self-collection kit that contains nasal swabs and saline, to be mailed to a facility for testing. On May 7, the FDA issued emergency authorization for the first diagnostic test using at-home collection of saliva specimens. Patients collect a saliva sample and return it to a laboratory for testing. Late last week, the FDA issued the first EUA for a COVID-19 antigen test. Antigen tests quickly detect fragments of proteins found on or within the virus by testing samples collected by the nasal swabs. Antigen tests can return results in minutes. Now the FDA has authorized three different types of tests – polymerase chain reaction tests, serological tests and antigen tests – each serving a different purpose. More rapid detection and at-home COVID-19 tests are expected to be authorized in the upcoming weeks in an effort by the FDA to increase access to tests while encouraging and maintaining social distancing.

Drugs

The FDA issued an EUA for the investigational antiviral drug remdesivir for the treatment of suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease. Remdesivir is not an FDA-approved drug. While there is limited information on the safety and effectiveness of using remdesivir to treat people in the hospital with COVID-19, the investigational drug in a clinical trial was shown to shorten the time to recovery in some patients.

The FDA also approved two generic drugs indicated to facilitate tracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation, both critical in patients hospitalized with COVID-19. Succinylcholine chloride injection USP 200 mg/10 mL and cisatracurium besylate injection USP 20 mg/10 mL were both approved as generics. Cisatracurium besylate injection is listed on the FDA drug shortage list.

The FDA took similar action for compounded drugs when it added epinephrine and morphine sulfate to the list of drugs outsourcing facilities and pharmacy compounders may produce during the COVID-19 pandemic. As in its policies for outsourcing facilities and pharmacy compounders, the FDA told purchasers, “Hospitals that cannot obtain adequate supplies of FDA-approved drugs and are considering the use of compounded drugs for their hospitalized patients should first contact outsourcing facilities, which are subject to more robust quality standards than state-licensed pharmacies or federal facilities that do not register with FDA as outsourcing facilities.” For a discussion of the policies for outsourcing facilities and pharmacy compounders, see our previous alert.

State Boards

New York Gov. Andrew M. Cuomo announced, “We’re going to form a consortium with our seven Northeast partner states, which buy about $5 billion worth of equipment and supplies. That will then increase our market power when we are buying and we will buy as a consortium, price as a consortium, for PPE equipment, ventilators, medical equipment, whatever we need to buy.” The joint multistate agreement to develop a regional supply chain for PPE, other medical equipment and testing includes Cuomo, New Jersey Gov. Phil Murphy, Connecticut Gov. Ned Lamont, Pennsylvania Gov. Tom Wolf, Delaware Gov. John Carney, Rhode Island Gov. Gina Raimondo and Massachusetts Gov. Charlie Baker.

New York also authorized COVID-19 testing by pharmacists. Under the executive order, New York-licensed pharmacists can order COVID-19 tests, authorized by the FDA, to detect SARS-CoV-2 or its antibodies and administer Clinical Laboratory Improvement Act-waived COVID-19 tests, subject to completion of appropriate training developed by the New York Department of Health. The department has yet to develop the training, however. Further dampening increased access to testing is the requirement that entities wishing to conduct high and moderately complex testing must obtain a clinical laboratory permit from the New York Department of Health, which, according to the New York State Office of the Professions, “is a complex process that most pharmacies are not positioned to undertake in the short term.”

New York followed Pennsylvania, which was one the first states to allow pharmacists to conduct COVID-19 testing. Ohio also joined by issuing guidance on the authority of pharmacists, pharmacy interns and certified pharmacy technicians to conduct FDA-authorized COVID-19 testing under certain conditions.

The state of Ohio Board of Pharmacy issued “Responsible RestartOhio Guidance for Licenses,” which replaces all previous infection control requirements issued by the board. This is one of the first state board of pharmacy guidances on reopening of workplaces during COVID-19. It is recommended that community pharmacies follow CDC guidance for community pharmacies. Drug distributors (manufacturer of dangerous drugs, outsourcing facility, third-party logistics provider, repackager of dangerous drugs and wholesale distributor of dangerous drugs) in Ohio must follow the Responsible RestartOhio mandatory provisions, which include ensuring a minimum of six feet between people or, if that is not possible, the installation of barriers.

Takeaways

Rapid response in the life sciences and pharmacy sectors continues to occur at both the federal and state levels to address the threat of the new coronavirus. We expect to see continued activity in this space and will keep you updated as we become aware of developments.