This update approaches three months of coverage of the Food and Drug Administration (FDA) and related regulatory response to COVID-19. Updates and developments continue in the COVID-19 response despite a decrease in media coverage. Here, we will provide an overview of where the regulatory response is today as well as general updates.
Health and Human Services (HHS)
HHS previously authorized pharmacists to order and administer FDA-authorized COVID-19 tests. In response to several states placing restrictions on pharmacists’ ability to order and administer FDA-authorized COVID-19 tests, HHS made it abundantly clear that “no State or political subdivision of a State may establish, enforce, or continue in effect with respect to [FDA-authorized COVID-19 tests] any provision of law or legal requirement that is different from, or is in conflict with” a pharmacist’s ability to order and administer FDA-authorized COVID-19 tests.
HHS announced a partnership with industry to expand pharmaceutical manufacturing in the United States for use in producing medicines needed during the COVID-19 response and future public health emergencies. The drug ingredients will be manufactured at facilities in the United States, including a new facility to be built in Virginia.
Domestic and foreign routine surveillance inspections will continue to be postponed except for certain mission-critical inspections, and the FDA will utilize and implement additional alternative inspection tools and approaches. The FDA further reaffirmed its continued postponement of inspections in its testimony to the Senate Finance Committee.
The Senate Finance Committee held a hearing titled COVID-19 and Beyond: Oversight of the FDA’s Foreign Drug Manufacturing Inspection Process. The FDA testified that for all FDA-regulated drugs, only 26 percent of manufacturing facilities producing active pharmaceutical ingredients and 46 percent of manufacturing facilities producing finished dosage forms are located in the United States. This may provide insight into HHS’s new partnership with industry to expand pharmaceutical manufacturing in the United States for use in producing medicines needed during the COVID-19 response and future public health emergencies.
The FDA updated the Questions and Answers appendix in Guidance on Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency. Previously, the FDA addressed submitting protocol amendments, documenting protocol deviations, initiating virtual clinical trial visits for monitoring patients, making changes to ship investigational products directly to patients, and obtaining and documenting informed consent from patients in isolation due to COVID-19. This update includes new content on using alternate laboratories or imaging centers, holding trial participant visits via videoconference, conducting required postmarketing clinical trials, managing protocol deviations and amendments to ongoing trials, and consulting with the FDA regarding administering investigational product infusions at home rather than at the clinical trial site. The updated guidance has a new questions-and-answers section on Part 11 compliance for electronic systems that are used to generate electronic signatures on clinical trial records.
To assist with obtaining informed consent remotely, which the FDA guidance discusses, the FDA made its MyStudies app available to investigators as a free platform to securely obtain patients’ informed consent for eligible clinical trials when face-to-face contact is not possible or practical due to COVID-19 control measures. FDA MyStudies is now referred to as COVID MyStudies.
The FDA also published guidance titled Institutional Review Board (IRB) Review of Individual Patient Expanded Access Requests for Investigational Drugs and Biological Products During the COVID-19 Public Health Emergency Guidance for IRBs and Clinical Investigators. In the guidance, the FDA provides recommendations regarding the key factors and procedures IRBs should consider when reviewing expanded access submissions for individual patient access to investigational drugs for treating COVID-19.
Diagnostic and Serological Tests
According to the FDA, more than 400 test developers have already submitted or said they will be submitting emergency use authorization (EUA) requests for COVID-19 tests. The FDA released a video explaining the differences between the types of tests: molecular tests, antibody tests and antigen tests. To date, under EUAs, the FDA has authorized 128 tests, which include 108 molecular tests, 19 antibody tests, and one antigen test. For the most up-to-date information regarding COVID-19 testing, the FDA continuously updates its FAQs on Testing for SARS-CoV-2.
Under the FDA’s Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency, commercial manufacturers of both diagnostic tests and antibody tests may distribute tests prior to issuance of an EUA as long as the FDA is notified. On its website at FAQs on Testing for SARS-CoV-2, the FDA provides a notification list of tests for which the manufacturer has notified the FDA of its intent to distribute while an EUA is pending. Indeed, if an EUA request is not submitted by a commercial manufacturer of a serology test within a reasonable period of time or if significant problems are identified with such a test that cannot be or have not been addressed in a timely manner, the FDA removes the manufacturer and test from the notification list.
The FDA has updated two guidances for the temporary compounding of certain human drugs during the COVID-19 public health emergency: outsourcing facilities and pharmacies. We previously discussed the guidances here. The FDA still maintains that hospitals that cannot obtain FDA-approved drugs and seek to use compounded drugs for their hospitalized patients should first contact outsourcing facilities that produce compounded drugs under more robust quality standards than those of state-licensed pharmacies or federal facilities. The FDA made a housekeeping change for both guidances by making the list of drugs for the purposes of the temporary enforcement policies available as stand-alone documents for outsourcing facilities and pharmacies. Outsourcing facilities must submit weekly product reports to the FDA for drugs compounded pursuant to the temporary enforcement policy. The FDA also granted outsourcing facilities a 90-day respite for essential copies of FDA-approved drugs – the FDA does not intend to take action against an outsourcing facility for filling orders for a drug product that is essentially a copy of an approved drug product, provided the drug appeared on the list of drugs used for hospitalized patients with COVID-19 within 90 days of the outsourcing facility compounding, distributing or dispensing the drug. Pharmacy compounders now must report adverse events.
Accordingly, the FDA updated a final guidance, Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic, to include information for compounded drugs. The guidance provides recommendations to industry regarding adverse event reporting for FDA-regulated products during a pandemic.
The FDA also issued guidance clarifying the FDA’s enforcement of certain requirements relating to the distribution of drug samples under the Prescription Drug Marketing Act of 1987. For the duration of the public health emergency related to COVID-19, the “FDA does not intend to take action against a manufacturer or authorized distributor of record that accepts alternate ways of verifying delivery and receipt of drug samples instead of obtaining the signature of the person acknowledging delivery” as long as other requirements are met. Under the guidance, the FDA provided a temporary policy regarding enforcement of the requirement for drug samples to be sent to the requesting health care practitioner licensed to prescribe the drug, or to a designee at the pharmacy of a hospital or other health care entity. The FDA also a clarified its interpretation of sample delivery directly to a licensed health care practitioner and confirmed that drug samples may not be distributed to a retail pharmacy.
To date, the FDA has issued more than 65 warning letters related to COVID-19. The FDA is aware of hundreds of products, including drugs, testing kits and personal protective equipment (PPE), sold online with unproven claims. FDA warning letters have originated from the FDA’s review of websites, social media accounts and labels. A federal court entered a temporary restraining order to stop the distribution of colloidal silver products. The colloidal silver products were marketed as treatments for COVID-19. The FDA and the Federal Trade Commission jointly sent the firm marketing these products a warning letter two months before the temporary restraining order was granted. The FDA is actively enforcing the Federal Food, Drug, and Cosmetic Act during COVID-19 unless temporary enforcement discretion has been announced in a guidance for industry. According to the deputy general counsel of HHS and the chief counsel of the FDA, Stacy Amin, “[t]he FDA will continue our efforts to make sure that this and other like-minded sellers comply with the law.”
In response to concerns relating to insufficient supply and availability of gowns and other apparel for use by healthcare personnel as PPE for use in healthcare settings in accordance with the Centers for Disease Control and Prevention (CDC) recommendations to protect both healthcare personnel and patients from the transfer of SARS-CoV-2, the FDA issued an EUA to help increase the availability of currently marketed and new gowns and other apparel for a medical purpose during the COVID-19 pandemic.
Firms importing filtering facepiece respirators or purchasing imported non-NIOSH-approved filtering facepiece respirators should review their suppliers and the reissued EUAs. The FDA reissued EUAs for decontamination systems and filtering facepiece respirators. The EUA Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China was revised to no longer authorize respirators listed in Appendix A if they are decontaminated. Decontamination systems are no longer authorized to decontaminate respirators manufactured in China. Additionally, decontamination systems are limited, so they authorize only decontamination of noncellulose respirators that do not have an exhalation valve that either is authorized in NIOSH-Approved Air Purifying Respirators for Use in Healthcare Settings During Response to the COVID-19 Public Health Emergency or is authorized and identified in Exhibit 1 of Imported Non-NIOSH-Approved Disposable Filtering Facepiece Respirators. The FDA is increasing scrutiny of imported non-NIOSH-approved filtering facepiece respirators.
The CDC updated Guidance for Pharmacists and Pharmacy Technicians in Community Pharmacies during the COVID-19 response. Universal face coverings and the use of engineering and administrative controls to encourage social distancing remain mainstay strategies recommended by the CDC for pharmacies. Notable updates include the recommendation to provide adult vaccinations based on local conditions. When providing clinical services, such as adult vaccinations, pharmacies should evaluate the risk of an in-person encounter versus the benefit of using the Framework for Healthcare Systems Providing Non-COVID-19 Clinical Care During the COVID-19 Pandemic. Additionally, pharmacies should develop a strategy for screening patients for fever and symptoms of COVID-19 prior to providing vaccinations.
New York Gov. Andrew Cuomo issued Executive Order #202.24, allowing pharmacies to bill for COVID-19 testing under Medicaid. The New York Department of Health issued Medicaid Fee-for- Service (FFS) Policy and Billing Guidance for COVID-19 Testing at Pharmacies, which remains in effect for the duration of Executive Order #202.24. NYS Medicaid FFS will cover COVID-19 specimen collection or Clinical Laboratory Improvement Act-waived COVID-19 testing at pharmacies in accordance with this executive order. Pharmacies will be able to bill only Medicaid non-dual-eligible members for FDA-approved or cleared tests or tests that have been authorized by the FDA under an EUA. Dual-eligible members will continue to access testing services through Medicare.
Maryland has instituted a Medicaid payment policy similar to New York’s. Under the Maryland Department of Health COVID-19 #18: Testing for COVID-19 by Medicaid Pharmacies, pharmacies may bill for specimen collection for COVID-19 testing.
The South Dakota Medicaid program will similarly pay pharmacists for providing COVID-19 testing services.
The pace of issuance of emergency regulatory policies affecting the life sciences and pharmacy sectors has stabilized at both the federal and state levels, aligning with the rate of new COVID-19 infections. Existing policies issued within the past three months continue to be updated and revised. We expect to see continued activity in this space and will keep you updated as we become aware of developments.