How Outdated FDA Regulations Affect the New World of Pharma Launches? With Dale Cooke, President of Philly Cooke Consulting
In this episode of Pharma Launch Secrets, Bozidar is joined by Dale Cooke, President of PhillyCooke Consulting, a company that focuses on ensuring that relevant stakeholders understand FDA regulatory requirements for the different categories of products and how to apply those regulations to new and emerging technology channels.
- Just how outdated are the FDA regulations?
- What is the new normal when it comes to product launches, regulations, and advertising?
- How can you creatively market pharma products without breaking the rules?
To answer these questions Bozidar is joined by Dale Cooke, President of PhillyCooke Consulting, a company that focuses on ensuring that relevant stakeholders understand FDA regulatory requirements for the different categories of products and how to apply those regulations to new and emerging technology channels.
👉 [01:47] The FDA regulations are particularly challenging, especially considering they were made in the 1960s. That being said, Dale admits that the regulations have to lag behind technology, as they don’t want them updating rules every week. It’s Dale’s job to guide stakeholders through those regulations, and how to apply them to new and emerging technology channels.
👉 [07:30] There will be times when you realize, late at night, that something you’ve written could have been interpreted in a completely different way from how it was meant to be understood. Dale explains that this is something he has experienced a few times in his work, but it can happen to anyone. In fact, people should experience it so that they know how to avoid it in the future.
👉 [09:34] In January of last year, pharma companies were claiming that they could never move to a remote working model, however within the next seventy-two hours, they did it just like that, revolutionizing the way people work and how they interact with each other. Dale believes that, although the situation isn’t as in flux as it was, we’re still figuring out what the new normal is.
👉 [14:12] Dale compares the creation and selling of FDA-approved products to writing a Haiku: you can be as creative as you like, but you need to stay within the parameters of a strict set of rules, otherwise, it won’t work.
If you want to learn more fascinating insights into the intricacies of pharma marketing and FDA regulations, tune into this episode of Pharma Launch Secrets, a Podcast by Evermed.
And connect with Dale here:
About The Show:
“Pharma Launch Secrets” is a podcast by Evermed and hosted by CEO Bozidar Jovicevic. We host direct, actionable conversations with world-leading pharma launch experts and help you stay up-to-date with the latest trends and strategies to help you launch your product successfully.