With COVID-19 continuing its domination of global life and headlines, life-sciences companies are working to develop tests, treatments and therapies to fight the virus. The US Food and Drug Administration has kept busy issuing advice, rulings and guidances on the virus; following are the latest news items.
The agency has issued guidances intended to help accelerate development of preventative and treatment products for the virus.
FDA Commissioner Stephen Hahn said, “Accelerating the investigation of safe and effective therapies that could benefit people affected by the COVID-19 pandemic is one of the FDA’s highest priorities. We are committed to maximizing our regulatory flexibility and using every tool at our disposal to speed the development and availability of these medical products and believe these new guidances will help innovators and researchers do just that.”
“COVID-19 Public Health Emergency: General Considerations for Pre-IND (Investigational New Drug application) Meeting Requests for COVID-19 Related Drugs and Biological Products” recommends a process (designed to be more efficient than in the past) for developers to receive agency feedback on their supporting data with the goal of starting clinical trials as soon as possible. It clarifies the types of data and information sponsors should provide to address clinical, nonclinical and quality considerations before submitting an application to initiate studies.
The second guidance, “COVID-19: Developing Drugs and Biological Products for Treatment or Prevention,” provides current FDA recommendations on later-stage clinical trials intended to establish safety and effectiveness for COVID-19 products. The guidance outlines critical sponsor considerations such as appropriate patient selection, including the evaluation of therapies in patients at high risk of complications from COVID-19 (e.g., the elderly).
Clinical trial guidance
The FDA has added new content to its “Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency” guidance document. The new information discusses considerations for using alternate laboratories or imaging centers, holding trial participant visits via video conference, and conducting required post-marketing clinical trials.
The document also includes updated information about managing protocol deviations and amendments to ongoing trials. Additionally, it recommends consulting with the FDA regarding administering investigational product infusions at home rather than at the clinical trial site.
The company issued an Emergency Use Authorization (EUA) to Sherlock BioSciences for its CRISPR SARS-CoV-2 Kit. This marks the first instance of authorized use of CRISPR technology for an infectious disease test.
The diagnostic test, according to the company, searches for the specific target RNA or DNA sequences of the SARS-CoV-2 virus in upper respiratory specimens, such as nasal swabs, and bronchoalveolar lavage specimens, such as from fluid in the lungs, from individuals suspected of COVID-19 by their healthcare provider. Use of the diagnostic tool is exclusive to laboratories certified under Clinical Laboratory Improvement Amendments (CLIA) to perform high-complexity tests.
Fraudulent tests and treatments
The FDA continues to keep a watchful eye for unscrupulous companies selling products promising COVID-19 prevention and cures. To date, there are no FDA-approved products for blocking or treating the virus.
The agency reports it has issued 48 warning letters so far to companies producing and promoting unproven products. These products include:
- Sublingual gel treatments purported to treat the virus
- “Viral Protection Kits” claiming to prevent infection
- CBD-based COVID-19 treatments
- Essential oils and dietary supplements
- Herbal cures
- Traditional Chinese medicines
- A treatment with honey listed as the primary, active ingredient