Allowing Off-Label Data Would Do More to Protect Public Health

As we all know, there are a lot of products successfully prescribed for off-label use, including those used for pediatric purposes without pediatric indications, aspirin prophylaxis for coronary disease in high-risk patients, and almost half of all treatments for headache-related diagnoses.

And since I’m going to be speaking at the FDA hearing, called Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products, I want to share some thoughts on the topic.

Before I tell you what I think the FDA should do, let me tell you why I’m so passionate about this topic. It affects me as a professional who has devoted my entire career to finding better ways to communicate between the pharmaceutical industry and the stakeholders it serves: healthcare professionals, patients and caregivers, and the healthcare system.

And, personally, I’m also a patient impacted by this very issue of using a product off-label. I’ve been a migraine patient all my life. As everyone in the industry knows, many managed care plans require a treatment protocol of on- and off-label products, tried one at a time, until failure — in the hopes of eventually finding the right solution. And, like most patients, I tried several PCPs and specialists. So that I could receive coverage (this is how managed care “keeps costs down”), they each proceeded through the same protocol to get to the most effective solution. One doctor recommended Norvasc, an antihypertensive. One recommended oral contraceptives. One told me to stop taking oral contraceptives. And so on, proving that migraine is a condition that is still mysterious to the scientific community. And extremely frustrating to me.


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Zoe Dunn
Zoe Dunn, President and CEO of Hale Advisors, is a digital marketing and communications specialist with over twenty years of experience in the field. She has extensive experience in both the agency and commercial marketing side of the pharmaceutical, medical devices, and biotech industries.

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