On September 14, 2020, Claudia Lewis was featured in Law360’s Coronavirus Q&A series, in which she discussed working with the Food and Drug Administration (FDA) during the pandemic, helping companies that manufacture personal protective equipment (PPE), and a new type of relationship with clients and colleagues that has emerged from working remotely. The following is an excerpt:
What questions are you currently fielding from clients?
In connection with COVID, a lot of clients have switched to being a PPE resource, both to distributing it and sourcing it for general purposes and creating their own lines of PPE. And so now the clients are asking me, "I'm assuming these emergency use authorizations are not going to stay in place forever," or "I'm in this for the long haul, I would like to take steps to get the full 510k or some other FDA oversight." We're sort of switching to making this more long term instead of meeting societal needs in the short term. So there's a lot of questions about importing — "How do I get those products in?" I've gotten a lot of questions about how to price these products in terms of making sure that you're not gouging. The Federal Trade Commission has some regulations and the states have regulations, so we've had to do a state-by-state survey to make sure the pricing is not overinflated.
Click here to access the article.
What questions are you currently fielding from clients?
In connection with COVID, a lot of clients have switched to being a PPE resource, both to distributing it and sourcing it for general purposes and creating their own lines of PPE. And so now the clients are asking me, "I'm assuming these emergency use authorizations are not going to stay in place forever," or "I'm in this for the long haul, I would like to take steps to get the full 510k or some other FDA oversight." We're sort of switching to making this more long term instead of meeting societal needs in the short term. So there's a lot of questions about importing — "How do I get those products in?" I've gotten a lot of questions about how to price these products in terms of making sure that you're not gouging. The Federal Trade Commission has some regulations and the states have regulations, so we've had to do a state-by-state survey to make sure the pricing is not overinflated.
Click here to access the article.