fda update on advertising and promotion of prescription drugs
DESCRIPTION
FDA Update on Advertising and Promotion of Prescription Drugs. Thomas Abrams, R.Ph., M.B.A. Division of Drug Marketing, Advertising, and Communications Food and Drug Administration January 30, 2006. Topics. Policy Updates Enforcement Updates 2006 and beyond. DDMAC’s Mission. - PowerPoint PPT PresentationTRANSCRIPT
FDA Update on Advertising and Promotion of Prescription Drugs
Thomas Abrams, R.Ph., M.B.A.Division of Drug Marketing, Advertising, and CommunicationsFood and Drug AdministrationJanuary 30, 2006
DDMAC’s Mission
To protect the public health by assuring prescription drug promotion is truthful, balanced, and accurately communicated
Direct-to-Consumer Promotion
Increasing interest Concerns about DTC PhRMA and Industry Actions FDA Actions
FDA Actions and DTC
Research on DTC conducted Sept 2003 – Public Meeting held on DTC
research Feb 2004 – 3 draft guidances issued Nov 2004 – DTC Research Final Report Nov 2005 – DTC Part 15 Meeting held
Risk Information
Most common violation cited in DDMAC’s letters
Important to public health American public entitled to balanced picture
Risk Information
Industry– make efforts to better present risk info– include serious and common risks
cannot omit risk from promotion
FDA– working on draft guidance for risk info presentation– taking necessary and appropriate enforcement
actions
Guidance Development
Presentation of Risk Information Brief Summary: Disclosing Risk Information
in Consumer-Directed Print Advertisements (Brief Summary)
Help-seeking and Other Disease Awareness Communications by or on Behalf of Drug and Device Firm (Help-seeking)
Enforcement Analysis
15 Warning Letters in 2005 vs 4-5 WLs average of previous years
Stopped and corrected misleading promotion Actions needed to achieve compliance
Types of Violations - Most Common
Inadequate Risk Information - 82% Misleading Effectiveness Claims - 43% Misleading Comparative Claims - 43%
Targeted Audience
Healthcare Professional Directed - 60% Consumer Directed - 30% Both HCP and Consumer Directed - 10%
Nipent Warning Letter
Booth panel and handout Overstatement of safety and efficacy Failed to present any risk information Boxed Warnings about severe renal, liver,
pulmonary, and CNS toxicities Untitled letter in 1997 – risk Untitled letter in 2001 – misleading claims
Nipent Warning Letter
Overstatement of Safety– Nipent is selectively cytotoxic to the leukemic
population, exhibiting little or no effect on stem cells
– Unsubstantiated and contradicts PI (use of drug is associated with multiple hematologic cytopenias)
Omission of risk information
Survanta Warning Letter
Direct mailer to healthcare professionals Effectiveness claims
– Large, colorful, bolded headers– colorful charts– bullet points
Risk information – small font in two lines at very bottom of page 3 of 4-page
promotional piece– below the references and footnotes
Quadramet Warning Letter
DTC radio ad, patient testimonial video, and website
Overstatement of effectiveness Omission and minimization of risk information
– Bone marrow suppression– Radioactivity in excreted urine
Quadramet Warning Letter
Quadramet doesn’t make you lose your hair, it targets the cancer and that is what so great about it. It knows where to go. I think it is amazing.
Quadramet travels to the site of bone reformation due to metastatic bone cancer to provide relief with a single injection.
After the Quadramet shot started to take effect, she was back to her old self, she wasn’t drowsy.
And I am surprised that she didn’t sit here and cook a big meal for you guys.
Lumigan Warning Letter
Sales aid Unsubstantiated superiority claims
– Weight of evidence proves LUMIGAN produces lowest mean IOP. For example…vs beta-blockers … vs travoprost… vs latanoprost… vs dual therapy
– Lumigan produces lowest mean IOP…vs dual therapy 14% to 27% greater mean IOP reduction than Cosopt
Remodulin Warning Letter
Journal ad and FAQ booklet Misleading comparative claims to Flolan
– Answer to “How is Remodulin different than Flolan” highlights advantages of Remodulin’s method of administration (subcutaneous vs. central infusion)
– “Can I Switch From Flolan to Remodulin?” “Yes in fact there were published results … where patients were successfully switched from Flolan to Remodulin.”
Both presentations fail to reveal material facts -- that Flolan has a proven effect on walking distance and survival in indicated patient population while Remodulin has not demonstrated these benefits
Cubicin Warning Letter
Journal advertisement and website Broadens the indication
– treatment of all infections caused by Staph aureus
PI states it is not indicated for pneumonia– In Phase 3 studies of community-acquired
pneumonia, death rate was higher
Correctives
Same audience and similar vehicle Correct misleading messages Examples – print ad, DHCP letter
Plans for 2006 - DTC
Part 15 Analysis and Follow Up PhRMA Guiding Principles
– Increase in number of submissions of proposals
Advisory comments Guidance Development
Plans for 2006 –Guidance Development and Voluntary Compliance
Guidance Development– Presentation of Risk Information– Help-Seeking Communications– Brief Summary research
Voluntary Compliance– Guidance– Advisory Comments– Outreach
Plans for 2006 - Enforcement
Continue close monitoring and oversight of prescription drug promotion
Take appropriate actions to ensure compliance
Continue efforts to encourage voluntary compliance