FDA COVID-19 roundup: actions and advisories
The US Food and Drug Administration continues to be kept on its toes with responses to the global COVID-19 pandemic. In addition to issuing drug- and product-related guidances, the agency also has been busy offering advice to both healthcare professionals and civilians and being vigilant in removing fraudulent treatments from the market.
‘All hands on deck’
This week, the agency released “FDA Voices: A Perspective on the FDA’s COVID-19 Response.” The document — written by Mitch Zeller, director of the FDA’s Center for Tobacco Products — gives an overview of the FDA’s comprehensive approach in tackling the pandemic.
In the document, the FDA reports its representatives have been proactive in the fight against the virus. Its strategy has involved using a scientific approach as well as other innovative methods to formulate responses on various fronts.
Chloroquine phosphate and hydroxychloroquine sulfate
Recommendations by President Donald Trump and various White House staffers to use the drugs to treat COVID-19 likely will cause an increase in demand for the products. The FDA announced it is taking various measures to help ensure a continued adequate supply of the drugs.
The agency FDA published product-specific guidances (PSGs) to support generic drug development for the treatments. Specifically, the PSGs clarify that chloroquine phosphate clarifies is AA rated, meaning there are bioequivalence problems and no in vivo studies are necessary. The revised hydroxychloroquine sulfate PSG adds advice about a Biopharmaceutics Classification System-based biowaiver option.
Additionally, the FDA announced it is prioritizing review of any newly submitted Abbreviated New Drug Applications (ANDAs) for chloroquine phosphate and hydroxychloroquine sulfate under MAPP 5240.3: Prioritization of the Review of Original ANDAs, Amendments, and Supplements.
Compounder PPE issues
The FDA has issued a number of guidances around supply and reuse of specific personal protective equipment (PPE) items, such as N95 masks. This week, the FDA issued a PPE-related guidance involving pharmacy compounders.
According to the agency, PPE shortages at pharmacy compounders could “significantly impact the quality, purity and availability of drugs that are compounded for patients, including those in critical need.” The guidance discusses how pharmacies may be able to preserve PPE if supplies are limited.
Further, the guidance enables compounders to use alternative PPE products, as long as they adopt risk mitigation strategies as enumerated in the guidance.
Fraudulent treatments
The FDA and Federal Trade Commission (FTC) has issued a slew of warning letters to companies charged with producing, promoting or selling fraudulent COVID-19 products. To date, there are no approved preventatives or treatments for COVID-19 available either through medical professionals or on the open market.
Accused purveyors of pseudo cures include Free Speech Systems LLC, DBA Infowars.com, a company accused of offering a colloidal silver toothpaste as well as a gargle. Infowars.com is a website operated by conservative provocateur Alex Jones.
