The US Food and Drug Administration’s Office of Prescription Drug Promotion issued six enforcement letters in 2020, just one more than the record low set in 2017. While citations declined they focused on some new areas, including COVID-19 claims and the placement of important safety information in emails.
US FDA Actions On Rx Drug Promos Covered New Territory Last Year
Office of Prescription Drug Promotion issued just six letters citing companies for improper drug promotion in 2020, including the placement of safety information in an email and making unfounded COVID-19 claims. New research projects focus on celebrity endorsements, medical conference materials.
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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.