On Wednesday, June 24th, MassBio hosted the Good Promotional Practices Before & After Approval Forum geared towards helping audience members in a range of drug development stages think about how to best promote their therapies.
Missed the Forum? We’ve compiled a list of key takeaways that are important to keep in mind as you move through the drug development process!
1) Be Different
“Differentiation is key. Walk out of a therapeutic space if you can’t differentiate from what’s out there” – Damon Harrell
Damon Harrell, Senior Director of New Product Planning at Alkermes, Inc. stressed that it is imperative to ensure your product has a unique therapeutic value. If you find you are unable to differentiate yourself, you should reconsider moving on. In the words of Damon: “Good science doesn’t always mean a desirable product.”
2) Channel the Patient Voice
“Be the voice of your customer as early on as possible and let the clinical team figure out how to get you that data.” – Harrell
Ensure the clinical team is aware of patient needs and their perspective. Help push the patient voice into the conversation and then let the clinical team work their magic to make a life-changing product.
“Your product should be aspirational, you want to meet the needs of patients.” – Harrell
By striving towards an aspirational goal and keeping the patient at the heart of the process, the team will stay focused on that goal and you will end up with a marketable product that makes a powerful difference in a patient’s life.
Side note: The panel also encouraged the audience to only speak in aspirational terminology in the pre-approval stages. Don’t promise any specifics!
4) Perfect your Label
“You can NEVER start too early or spend too much time writing your label!”- Harrell
“Assume if it’s not in your label that you can’t say it to a physician or patient.” – Harrell
“Don’t build your label around promotions, build it around therapeutic value.” – Ann Karen Henry
Labels were a big topic of conversation throughout the forum. Damon Harrell and Ann Karen Henry, Principal at APL Strategic Regulatory Consulting, say you need to make sure you get it right or there can be serious repercussions. The FDA provides guidance but the rules are ever-changing. Ensure you understand the guidance and the caveats that come along with it. If you don’t – ask for help! The Office of Prescription Drug Promotion (OPDP) is a great resource willing to provide advice.
5) All Eyes are on You
“The FDA spends time scrutinizing pre-approval stages. Including monitoring the conferences your company is attending.” – Henry
The FDA is paying close attention even in the pre-approval stages. Be aware and know the rules to avoid missteps. Keep in mind the FDA isn’t the only one watching. The DOJ, attorney general, shareholders, competitors and more are all keeping an eye out!
6) Be Honest
“If you say the good, you’ve got to say the bad and you can’t just put the bad in tiny font! Layout matters.” – Linda Pollitz
Of course you want to showcase the incredible capabilities of your product, but Linda Pollitz, Director of Regulatory Affairs Advertising & Promotional Labeling at Alkermes, Inc. says you must be clear about the potential risk factors and side effects. You can’t just put the negatives in tiny font and hope no one sees them. The fact is they exist, acknowledge it and do your best to promote the positives.
If you are a MassBio Member and are looking for some more insight from this Forum, login to your Member Portal where you can stream the entire event!
Be sure to keep an eye out for our upcoming Forums!