Marketing & Advertising
Final guidance on communicating scientific information on unapproved uses (SIUU) allows firm-generated presentations to be based on sources other than reprints, but says communications based on nonscientific content are not protected from enforcement.
The compounding industry ties for Martin Makary, President-elect Trump’s candidate to lead the FDA, could mean less compounding enforcement, experts said, but government officials said their enforcement focus will remain nonpartisan.
The loss of institutional knowledge about OPDP’s prior comments on promotional materials can result in an enforcement letter for the new owner of a company or product, experts say.
An Office of Prescription Drug Promotion “untitled” letter cites a short-form video by interior designer and TV personality Nate Berkus, continuing an enforcement trend involving drug promotions by social media influencers and celebrities.
Written contracts should be detailed, require compliance with FTC and FDA requirements, and guard against activities that may damage a company’s reputation, experts said.
China has proposed new guidelines designed to head off potential bribery by pharma companies related to the conduct of clinical studies and possible manipulation of outcomes.
Advertisers are facing a 20 November deadline to bring TV and radio ads into compliance, but stakeholders still question the reg’s scope, including whether and how it applies to ads on streaming services and social media platforms. FDA advisory comments suggest the agency is taking a hard stand on the rule’s ‘dual modality’ requirement.
A panel of experts from J&J, UCB and Takeda deliberated on the use of AI and internal processes to strike the right balance between speed and accuracy in MLR reviews that could protect a company from serious repercussions. They also spoke of the need for regulatory systems to catch up.
Australia’s industry group has updated its code of conduct with a number of new provisions, including one that clarifies its stance on members using its complaints system to disrupt another company's business.
Multiple and repeated complaints will sharpen the Office of Prescription Drug Promotion’s focus on an advertisement, Director Catherine Gray said, while Foley Hoag partner August Horvath said the self-regulatory NAD process is best suited to complaints that lack a ‘great scientific basis’ for objecting.
The COSIsiFA initiative includes a new independent website, regular newsletters, a six-monthly bulletin, and training courses to help promote the appropriate use of medicines.
The newly published revised code of practice from the UK drug industry association moves certain elements from “guidance” to “mandatory” status, includes an option for providing prescribing information via QR codes, and promises to resolve complaints faster.
Pink Sheet reporter and editor discuss the FDA’s latest advertising enforcement letter, which targeted a migraine treatment TV commercial featuring Serena Williams, and its impact on drug promotion, as well as the now growing list of legal cases targeting agency decisions with Chevron deference overturned.
Developments in India and Pakistan are designed to standardize how drug companies disclose their expenses associated with health care professionals.
AbbVie’s migraine ad overstates the drug’s benefit, a problem that is amplified by using a celebrity, the agency says.
The launch of Pfizer's new direct-to-consumer program for vaccines and migraine drugs follows the introduction of Eli Lilly's LillyDirect in January. Company-branded initiatives are careful to partner with third-party vendors and allow the use of treatments marketed by other companies to avoid compliance pitfalls.
The lung cancer drug Krazati from Bristol Myers Squibb’s Mirati Therapeutics drew an FDA ad/promo untitled letter, highlighting the agency's trend of pursuing false or misleading efficacy claims, particularly when data comes from outside approved labeling.
The UK and EU pharma industry associations have defended their respective codes of practice despite alarming study results. Meanwhile, a consultation on proposals to revise the UK code received over 3,500 comments.
HPV vaccine shipments to China are expected to fall after a government crackdown on bribery and corruption caused scientific communication with health care providers to decline. Gardasil also may be hurt by budgetary pressures on distribution of the government-reimbursed vaccine.
An instagram post by Brittany Mahomes, wife of Kansas City Chiefs quarterback Patrick Mahomes, failed to contain any risk information for the epinephrine injector, the FDA’s Office of Prescription Drug Promotion said in an untitled letter.