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Industry, Patient Advocates at Odds as FDA Revisits Off-Label Communication

November 11, 2016, FDA Week

Michael Labson spoke at an FDA public hearing on behalf of the Pharmaceutical Research and Manufacturers of America where he laid out a stepwise approach PhRMA believes FDA should take regarding off-label communication, and is quoted in an FDA Week article. According to Labson, FDA should create three safe harbors for different types of communication: first, communication with payers; second, communication of real-world evidence with health care professions; and third, communication with healthcare professionals of medically accepted unapproved uses.

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