Consultant Lawyer or Going In-House: An Interview With Kenneth White

Darshan: Hey, Kenny. Kenneth: How's it going? Narrator: This is the DarshanTalks Podcast. Before this week's podcast, Consultant Lawyer or Going In-House, an interview with Kenneth White, Darshan will introduce this episode with the recap for the week of Thursday, June 25th, 2020. Darshan: So this week has been, as expected, a bit of a continuation from last week. However, what we're starting to see is the government is now taking a lot of the lax regulations that it had and it's now starting to enforce a lot of them. We're starting to ensure that not only are products available for people, but that they actually meet the standards that these products should have, the medical products should have. So for example, the Department of Justice has charged a manufacturer for exporting misbranded masks. At the same time, there was a writeup recently about stem cell companies selling hope for COVID-19 and that also has been deemed to be problematic because there are no proven therapies for the treatment of COVID-19. There was also, as you know, hydroxychloroquine and there was a question about whether it could be effective or not. And the FDA came out and revoked the emergency use authorization for hydroxychloroquine and basically said that it doesn't meet the standards that are necessary. The other interesting things happening this week were that the EMA came out and it's talking about providing free orphan drug advising to academia. So if you're working with orphan disease states, this becomes really quite interesting, especially if you are the early phases and you're in academic institutions. There is some interest right now, a New Jersey doctor came out and sued the ... Reached out again, the NIH and USPTO under FOIA and accused them of unfairly denying his requests for records over DNA. So if you look at the newsletter, you might find some more interesting notes about that. What I thought was really interesting was that the FDA also took this opportunity to look at its pilot program on patient reported outcomes from cancer clinical trials and it's putting some of that information out. So stay tuned, that could be relatively game changing as we continue. This was also the week in which, if you are a general counsel, the U.S. Supreme Court ruled that the Title VII protections extend to LGBTQ employees. So you may want to update your employee handbook and the like as you continue. If you have any questions about how any of these apply to you, feel free to reach out, obviously you can reach me at DarshanTalks, but I like to use these opportunities to talk about some of the other issues that are popping up. This was also a week in which I actually saw my first personal protective equipment with a company brand on it. And is that the future of healthcare where people walk around with drugs with company logos on it? And you might say, "Well, don't you already have the drug company's logo on it?" Yeah, I guess that's part of it, but I'm not sure how I feel necessarily about another company's logo on your drugs or your medical devices. Maybe things will change, maybe I will change, but I just thought that was interesting. If you think that that is unusual, if that's a step too far, feel free to leave me a message, tweet me on Twitter, and I'd love to hear from you. Narrator: This is the DarshanTalks Podcast. Regulatory guy, irregular podcast, with host Darshan Kulkarni. You can find the show on Twitter @darshantalks or the show's website at darshantalks.com. Darshan: Hey everyone. Welcome again to another episode of DarshanTalks. We have a really special guest, we have Kenneth White. And I've known Kenny for almost a decade at this point and one of my favorite memories with Kenny was enjoying a really cool meal in S...