If The ‘SIUU’ Fits: The New Vocabulary Of US FDA ‘Off-Label’ Policy

An updated US FDA policy governing dissemination of ‘off-label’ journal reprints and other scientific communications suggests the agency feels on firmer legal ground to reaffirm some guardrails. It also expands the regulatory vocabulary to include ‘scientific information on unapproved uses,’ or SIUU.

stethoscope and literature
• Source: Shutterstock

A newly updated US Food & Drug Administration guidance for sponsors on dissemination of journal articles and similar content that discusses “off-label” uses of approved therapies introduces a new item to the lexicon of regulatory jargon: SIUU, or “scientific information on unapproved uses.”

More from Marketing & Advertising

Are Bigger Ad Policy Changes Coming After US FDA’s Drug Promotion Office Hit Hard By Layoffs?

 
• By 

The loss of policy analyst, legal, project manager and social scientist positions has experts wondering if the Trump Administration is eyeing a broader effort to limit DTC advertising. The OPDP layoffs are expected to result in delayed reviews of promotional pieces.

US FDA Cites Taiho’s Lytgobi Healthcare Provider Website For Misleading Efficacy Claims

 
• By 

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.

How To Leverage US FDA’s ‘Consistent With Labeling’ Guidance In DTC Ads

 
• By 

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.

Ad/Promo: Improved Adherence Claim For Dexcel’s Hemady Not Supported, US FDA Says

 
• By 

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.

More from Compliance