Food and drug regulatory specialists help turn vodka into sanitizer

Wade Ackerman and Scott Danzis spoke with the Daily Journal about their work with clients on emergency use authorization (EUA) requests.

Mr. Ackerman says of the firm, “One of the things I appreciate about being in California, but also part of this firm that’s deeply connected with D.C., is that we have connectivity with what’s going on at FDA and on the Hill.”

Regarding EUAs, he says, “That’s a specific authority that Congress gave FDA to use during a declared public health emergency. FDA has issued a number of EUAs for tests [PPE] and ventilators. We’ve seen at least one EUA for a therapeutic and certainly know that FDA is looking closely at what other therapeutic options could be authorized.” He explains that “therapeutic” is an FDA term for something that treats the virus directly, like a vaccine or an anti-viral drug. “EUA is the most likely mechanism that FDA will use to bring therapies online for coronavirus, at least in the near term.”

Mr. Danzis says, “We’re engaged extensively with traditional medical device companies who are trying to get products through FDA as fast as possible. We’re also working with companies that have never been FDA regulated but are looking at what they can do by converting their manufacturing expertise and equipment to make personal practice equipment or other products. We help them understand what the liability implications of making these products available would be and whether there’s certain protections and immunities that they can avail themselves of, and there’s just a million other questions about how they import products or export products.”