5 questions raised at the FDA’s off-label hearing

One physician believes that changing regulations to allow off-label communications would mean there is less of an incentive for drugmakers to take their therapies through the FDA approval process. That view and others were shared Wednesday at the first day of the FDA’s public hearing to solicit input from pharma companies, insurers, patient advocates, and others as the agency reviews its policies regarding off-label communications.

The hearing — held at the FDA’s headquarters in Silver Spring, Maryland — is the latest episode in the long tug of war between the industry and the FDA on whether truthful and non-misleading information may help or hinder healthcare providers and payers in their decision making.

Here are five issues raised at the FDA hearing.


Patients need an accessible resource to find information about experimental drugs and ongoing clinical trials.

Zoe Dunn, principal at Hale Advisors, described GlaxoSmithKline’s online database of its own clinical research as a good example of how patients need access to better information about experimental medicines and ongoing clinical trials. She said, however, in response to a question from Dr. Sherman that ClinicalTrials.gov “falls short from being patient and health literacy friendly. This [information] needs to be more publicly accessible.”

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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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