The US FDA’s decision to finalize a promotional guidance defining a new class of permitted claims that are “consistent with the label” is probably disappointing to some advocates for broad readings of the First Amendment as it applies to drug company communications.
Learning To Love The “CFL”: US FDA’s New Communication Policy
Final guidance on communication “consistent with the label” is noteworthy for how closely it follows Obama-era draft. That may be a surprising twist given the background of the Trump-era FDA Commissioner and HHS Secretary – but on balance is probably the best possible approach for maintaining the current FDA approval climate.
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Results from a single-arm study cannot support representations on overall survival, progression-free survival and disease control rate for the cancer drug, the Office of Prescription Drug Promotion said in another “untitled” letter implicating the agency’s CFL guidance.
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Sponsors should review longstanding agency concepts on consumer-friendly language and claims limitations, along with Office of Prescription Drug Promotion research and enforcement, when applying the 2018 CFL guidance to direct-to-consumer advertising, Sidley Austin’s Cope says.
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A retrospective analysis does not support a claim that multiple myeloma patients are more adherent to Hemady than generic dexamethasone, OPDP said in an "untitled" letter suggesting increased enforcement focus on promotions leveraging the agency’s 2018 CFL guidance.
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Sponsors should consider the DTC ad's audio as the major statement about a prescription drug’s side effects and then choose strategically how to display the accompanying text. TV ads are now employing banners and larger text to satisfy the rule’s “dual modality” requirement.
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A global collaborative inspections pilot reduced the number of individual inspections for participating manufacturing facilities, demonstrating that multiple regulatory authorities can carry out joint inspections using a mix of on-site and remote approaches.
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The UK’s medicines regulator is pressing on with clarifying its expectations on decentralized manufacturing of medicines.
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Sponsors should review longstanding agency concepts on consumer-friendly language and claims limitations, along with Office of Prescription Drug Promotion research and enforcement, when applying the 2018 CFL guidance to direct-to-consumer advertising, Sidley Austin’s Cope says.