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Biogen's Experience Highlights Challenges With Expanded Access Programs

 
• By Sue Sutter

Expanded access program for rare pediatric disease treatment did not enroll many patients due to clinician community overwhelmed by patient demand and questions over who would pay ancillary drug costs.

Even when a drug manufacturer is able and willing to make an investigational therapy available through expanded access, the success of such programs may hinge on the clinical community's response, as well as logistical and financial considerations.

Tammy Phinney, vice president of regulatory affairs at Biogen Inc., shared the company's experience with one expanded access program...

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