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Rx Drug Promotion: Potential Enforcement Worries

 
• By Brenda Sandburg

Pitfalls of using third-party hubs for reimbursement assistance, sharing preapproval data with patient groups, and promoting biosimilars with labeling carveouts are among the concerns noted by panelists at FDLI conference.

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Prescription drug promotions face hurdles from pre-approval communications to label carveouts • Source: Shutterstock

Biopharma executives and outside counsel honed in on several issues that could impact the way companies promote their medical products at the Food and Drug Law Institute’s advertising and promotion conference last month. Below are some activities they worry could be the subject of enforcement action, as well as a court ruling that could restrict biosimilar promotion.

One panel was devoted to the risks that drug and device manufacturers face with their use of hubs that assist healthcare providers with reimbursement, including

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