Welcome back to the #V3Podcast.
This is The Vision, the Voice & the Value of Medical Affairs with Host, Dr. Anne Arvizu and Guest, Dr. Darshan Kulkarni.
Dr. Darshan Kulkarni is the Principal Attorney of the Kulkarni Law Firm and focuses his practice on helping FDA regulated companies successfully bring their products to market. He has over 20 years of experience in providing legal, medical, and regulatory services. Darshan has served as a pharmacist for over a decade – making him uniquely well-positioned to help clients through all stages of the development process. He advises clients on issues varying from FDA regulatory strategy, clinical trial negotiations, manufacturing audits, FDA compliant promotional and non-promotional review, FDA responses, to genericization and other interdependent processes.
In this episode, Anne opens the show explaining the term “unlabeled use.” In the United States, doctors use this all the time. They aren’t going to stop prescribing medicine if a drug will be beneficial to a patient. Darshan poses the question: is label and labeling the same thing? The goal of the FDA is to make sure the products are safe and not misbranded. The label is what is on the bottle. Labeling is anything that goes with the bottle. The term “goes with” is exceptionally broadly defined. Your sales materials can be considered labeling. If your sales rep speaks off label, that’s still part of the labeling of the bottle.
In the early 2000s, the FDA started going after companies about how medical affairs people were going off-label and acting as supercharged salespeople. The industry said that wasn’t true. The medical affairs, people are having a scientific conversation. There are categories of information that are not subject to censorship – such as a political speech. You can’t shut down political speech just because you do not like what they are saying. However, you can shut down two scientists because you do not like what they are saying. The FDA went to court with the pharma companies and lost the first case.
Every so often, people ask why the FDA won’t stop doctors from prescribing off label. The FDA has no jurisdiction over doctors. Prescribing is entirely legal, but off label marketing is not okay. All of the top fines that companies pay are from off label marketing. IMS Health Inc. collected data from people and gave the data to pharma companies. The state of Vermont said they were not able to sell the data because the companies would target the doctors too much, and it might raise the cost of prescribing. The Supreme Court asked: is it truthful and not misleading? Vermont said yes, but there was a cost to it. The Supreme Court said you couldn’t stop people from saying something simply because there will be a cost to it.
So what constitutes truthful and not misleading? To claim the FDA, you need randomized controlled studies – substantial evidence. If you want to make health economics claims, it does not require significant evidence. No one knows the difference between truthful and not misleading. Another case came up: United States v. Caronia. Ex-Orphan Medical sales rep Alfred Caronia successfully argued to a court that the First Amendment gives him a right to promote drugs for uses not approved by the FDA. The critical thing to look at is the role a person will play in a particular context – are they playing a salesperson or a physician?
Stay tuned to hear Dr. Darshan Kulkarni explain why we need medical affairs, the future of our industry, and why the industry is pushing back against the FDA.
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If you need more information regarding achieving value in medical affairs departments or learning more about Dr. Anne Arvizu then please visit the RxER Communications website here.
This show is being produced by the Pharmacy Podcast Network and is partner-sponsored by The Accreditation Council for Medical Affairs (ACMA) to help better serve the next generation of medical affairs leadership and adding value by supporting the medical experts and compliance leaders in our industry. You can find out more about ACMA here.
In this Episode:
- About unlabeled uses [ 2:50 ]
- About Dr. Kulkarni [ 5:30 ]
- The difference between label and labeling [ 9:30 ]
- Cases from the FDA [ 12:50 ]
- Misbranding [ 17:45 ]
- Presenting new data [ 20:50 ]
- IMS Health Inc. v. Sorrell [ 22:50 ]
- United States v. Caronia [ 27:00 ]
- Sales reps can speak off label [ 40:00 ]
- Why keep medical affairs? [ 43:30 ]
- The future of our industry [ 50:00 ]
- About guidance documents [ 53:00 ]
- “At this moment, a sales rep can speak off label – there’s nothing to stop them.” -Dr. Darshan Kulkarni
- “There’s a strong line between commercial and medical affairs.” -Anne Arvizu
- “I don’t see big pharma changing.” -Dr. Darshan Kulkarni
- “I shouldn’t be limited whether I’m in a company or out of a company to state what I feel.” -Anne Arvizu
- “No one knows what truthful not misleading means.” -Dr. Darshan Kulkarni
- Darshan Talks: https://www.darshankulkarni.com/podcasts/
- Darshan’s Newsletter: https://www.darshankulkarni.com/newsletter/
- Darshan’s Twitter: https://twitter.com/darshantalks
- Darshan’s Instagram: https://www.instagram.com/darshantalks/
- Darshan’s LinkedIn: https://www.linkedin.com/in/darshankulkarni/
- IMS Health Inc. v. Sorrell: https://www.oyez.org/cases/2010/10-779
- United States v. Caronia: https://harvardlawreview.org/wp-content/uploads/pdfs/vol127_united_states_v_caronia.pdf