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.

2020-2021 PINK SHEET PERSPECTIVES - Megaphone
FDA issued fewer Rx drug promo enforcement letters in 2020 while initiating six new research projects • Source: Shutterstock

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.

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

Japan Pushes Generic Industry Reforms Via New Govt Fund

 
• By 

Amid ongoing generic drug supply problems, Japan's government is to set up a new fund to support corporate investments geared towards manufacturing and consolidation.

Will They Or Won’t They? Tariff Questions Loom For Drugmakers

 

Pharma executives and investors are waiting with bated breath to find out if President Trump will include drugs in a new round of tariffs to be announced on 2 April.

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.