Is Off-Label Marketing by a Pharma Company a Bad Thing?

Narrator: This is the Darshan Talks Podcast. Before this week's podcast, Is Off-Label Marketing by a Pharma Company a Bad Thing?, Darshan will introduce this episode with the recap for the week of Thursday, June 11th, 2020. Darshan: As the stock market might tell you, we're starting to come out of what would normally be thought of as the depths of COVID. We're now starting to see regulatory agencies take the position that crisis, while it's still upon us, the balance has shifted from availability to making sure that products are actually safe and effective. The FTC just sent out 16 multilevel marketing companies a warning letter about coronavirus and essentially saying that they're making unsubstantiated claims. Apple has decided to start sharing COVID screening data with the CDC, which raises some privacy concerns, obviously. But, it's kind of interesting to start thinking about it. 3M sued an Amazon seller over fake N95 masks. Customs officers seized 10,000 coronavirus face masks in Philadelphia. So, what we're really seeing is this trend of, okay, we know that we now have to live with COVID, how do we make sure that the products that are out there are safe and effective? What has also happened is that, we're starting to see the FDA start taking learnings from the pandemic, essentially. And Dr. Stephen Hahn, the head of the FDA, the FDA commissioner, has suggested that lessons learned during the pandemic will lead to permanent improvements at the FDA in process and policies. So they're starting to work with non-traditional manufacturers to increase the national stockpile of ventilators and personal protective equipment. And upwards of 100 emergency use authorizations were issued for the evaluation of new tests, devices, and potential therapies. In the same way, in the case of a public health emergency, the risk/benefit decisions were not as robust as usual, which meant that new data was incorporated, and the FDA is now revisiting some of those decisions to protect consumers from inaccurate tests. Obviously, he remains sure that the FDA has measured up. I'm not sure I necessarily saw that when I was looking and talking to people. There seems to be a very high level of false positives, and potentially a bunch of false negatives as well. But we'll find out as the analysis starts happening. The FDA also has expressed a general interest in allowing decentralized clinical trials. And they're talking about using more telemedicine for clinical trial participants. The question is, will this translate over into opioid and narcotic tests, which have had complications with telemedicine? So if you are looking at what that means, state tuned. Obviously, the FDA is still looking at what they found so far. The FDA also started doing some of their own analysis for fiscal year 2019, and they identified that there was an 8.6% decrease in the number of drug manufacturing sites. So it went down from 4,676 in 2018, to 4,273, despite 382 new sites being added. And that was allegedly because of manufacturers that had no application products such as over the counter drugs and homeopathic products. There was also a drop of inspections and compliance, and the investigators performed 1,258 drug quality surveillance inspections in 2019, from the 1,346 in 2018. So again, the question is, what's going on there from a manufacturing viewpoint? They did say that based on 10 point inspection score, the overall average for inspections in fiscal year 2019 was 7.4, with the average scores for the U.S. being higher than the rest of the world at 7.7-7.6. On the other hand, China had a score 7.0. And India and Latin America had scores of 6.8. Which really speaks to the level of quality that these countries need to start developing on.