FDA Relaxes Requirements for COVID-19 Testing
In early February, the Secretary of Health and Human Services determined that the respiratory disease, called Coronavirus (COVID-19), caused by the virus SARS-CoV2, is a public health emergency justifying the authorization of emergency use of in vitro diagnostic tests for cases in the US. To achieve rapid and widespread testing for COVID-19, the Food and Drug Administration (FDA) then relaxed its regulations on the development of diagnostic tests by specific laboratories and commercial manufacturers.
Accelerating the Availability of COVID-19 Testing
Drug and device manufacturers should be aware that, under the new FDA guidelines, departments of health in states or territories can authorize laboratories to develop and perform tests to detect COVID-19 during the pandemic outbreak. Authorized laboratories can use serological testing and leverage diagnostics from commercial manufacturers for specimen testing without submitting Emergency Use Authorization (EUA) requests to the FDA; the state or territory takes responsibility for it.
The FDA has also accelerated the submission and authorization of an EUA for tests to detect COVID-19 by laboratories that perform high-complexity testing. Hoffmann-La Roche Ltd., for example, received an EUA for its cobas SARS-CoV-2 Test, which runs on the company’s cobas 6800 and 8800 systems that are widely available in the US and global markets. Roche’s COVID-19 test can purportedly deliver results to patients in fewer than 24 hours. According to Bloomberg, Abbott Laboratories has also received an EUA for its coronavirus test, which can apparently provide results in as few as five minutes and the company plans to supply 50,000 daily tests beginning April 1st.
While Roche ramps up COVID-19 testing, the company agreed to work with Forge Therapeutics to treat bacteria caused by other lung infections. The agreement aims to treat hospital-based infections occurring in people with chronic lung disease and compromised immune systems.
FDA Guidance to Follow
Recognizing that COVID-19 may impact the conduct of clinical trials of medical products, the FDA issued guidance (FDA-2020-D-1106) to ensure the safety of trial participants considering site closures, quarantines, travel restrictions, and interruptions in investigational product supply chains caused by the pandemic. It includes:
- Informing participants of changes to the study and monitoring plans;
- Implementing additional methods for safety assessments via telephone, virtual visits, and alternative locations; and
- Arranging alternative secure delivery methods for self-administered investigational products.
Other recent FDA guidance aimed to expand the availability of face masks, particulate filtering facepiece respirators, ventilators, and non-invasive remote monitoring devices to facilitate patient monitoring while reducing patient and healthcare provider contact and exposure to COVID-19 (FDA-2020-D-1138). The FDA also released a temporary policy for the preparation of alcohol-based hand sanitizer products during the public health emergency (FDA-2020-D-1106).
How Frier Levitt Can Help
Frier Levitt attorneys have in-depth life sciences industry knowledge and provide representation and advice to manufacturers related to formulation, labeling, promotion, and marketing of various pharmaceutical products and medical devices. Contact Frier Levitt today if you have a legal question concerning diagnostic testing governed by the FDA or if you need assistance with launching your product or device.
