Promotional Compliance and Lab Testing with COVID-19: An Interview with Stephanie Noblit and Dale Cook

Narrator: This is the DarshanTalks Podcast, before this week's interview with Stephanie Noblit and Dale Cooke on promotional compliance and lab testing with COVID-19, Darshan will introduce this episode with the recap for the week of Thursday, May 7th 2020. Darshan: So here are some interesting bits of information that have occurred in the last week that might be relevant. Number one, Health and Human Services issued a notification about enforcement discretion for provision of telehealth services during the COVID-19 pandemic. What does that really mean? It means that, number one, a lot of companies have come out and said, oh, they've legalized telehealth using FaceTime and they're like, "That's not what they've done." What they've done is they've simply said, we will use enforcement discretion which means, we will choose not to enforce at least during this one period of time. There are significant limitations. Darshan: They actually said that they will not impose fines for non compliance with the regulatory requirements like not having the appropriate business associate agreement in place, but certain steps do need to be taken. That includes, enabling all available encryption and privacy modes, notifying the patient that third party applications, pose a potential privacy risk. So keep that in mind as you continue. The second bit of information that's popped up is that a lot of individuals and companies believe that the FDA has stopped doing audits during this time. It seemed that that's not true. Darshan: The FDA just warned an Indian testing company, two device makers and a university lab for running a non clinical trial for a medical device. If you need more information, feel free to reach out about that. Do you believe that the FDA should be doing this testing? If you disagree with that, feel free to reach out. Feel free to comment on Twitter. You can reach me on twitter @DarshanTalks. The other bits of information is that, the PPP loans just came into play. And people have been wondering what this means, because PPP loans, what happens if the employee doesn't want to come back? Darshan: Do you have to give those PPP loans back? So the EEOC provided some interesting information about that, and so did the Treasury. And off that, the question that was asked was, will a borrower's PPP loan forgiveness amount, be reduced if the borrower laid off an employee, and offer to rehire the same employee, but the employee declined the offer? And the short answer is no. That would not be the case. If you need more details, feel free to reach out about that as well. There is another interesting bit of information happening. Specifically, the question of clinical trials versus the right to try, and people are wondering what does this mean? What is the difference? Darshan: So clinical trial is working on the proposition that both arms of a clinical study are equivalent, and the right to try works with the proposition that you have a preferred option. So with clinical trials, if you look at it, the subject enters into the clinical study with what's known as equipoise. And that means that they do not believe that there is any difference between the two arms of the randomized trial, for the randomization to be ethical. However, that analysis does not consider if while the individual patient may be indifferent, the researchers themselves may not be, so they may be actually aiming for a specific result. Darshan: So, that becomes more complicated in the context of a pandemic, where patients just want to get better, while the actual individual researchers are hoping for one line of treatment, so that they can help other people. So, where a patient has a rational preference for the treatment,