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FDA Update on Advertising and Promotion of Prescription Drugs. Thomas Abrams Division of Drug Marketing, Advertising, and Communications Food and Drug Administration February 22, 2006. Topics. Policy Updates Enforcement Updates 2006 and beyond. Policy Updates.

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fda update on advertising and promotion of prescription drugs

FDA Update on Advertising and Promotion of Prescription Drugs

Thomas Abrams

Division of Drug Marketing, Advertising, and Communications

Food and Drug Administration

February 22, 2006

  • Policy Updates
  • Enforcement Updates
  • 2006 and beyond
policy updates
Policy Updates

Direct-to-Consumer Promotion (DTC)

Risk Information

Guidance Development

risk information
Risk Information

Most common violation cited in DDMAC’s letters

Important to public health

American public entitled to balanced picture

risk information1
Risk Information


include serious and common risks

cannot omit risk from promotion

make efforts to better present risk info


taking necessary and appropriate enforcement actions

working on draft guidance for risk info presentation

guidance development
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
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
Types of Violations - Most Common
  • Inadequate Risk Information - 82%
  • Misleading Effectiveness Claims - 43%
  • Misleading Comparative Claims - 43%
targeted audience
Targeted Audience
  • Healthcare Professional Directed - 60%
  • Consumer Directed - 30%
  • Both HCP and Consumer Directed - 10%
violations concerning risk information
Violations concerning Risk Information
  • Nipent Warning Letter
  • Survanta Warning Letter
nipent warning letter
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 information
  • Untitled letter in 2001 – misleading claims
nipent warning letter1
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
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
misleading effectiveness claims
Misleading Effectiveness Claims
  • Quadramet Warning Letter
quadramet warning letter
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 letter1
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.
misleading comparative claims
Misleading Comparative Claims
  • Lumigan Warning Letter
  • Remodulin Warning Letter
lumigan warning letter
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
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
  • Same audience and similar vehicle
  • Correct misleading messages
  • Examples – print ad, DHCP letter
plans for 2006 guidance development and voluntary compliance
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
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

ddmac information
DDMAC Information
  • Phone numbers:
    • Phone - (301) 796-1200
    • Fax - (301) 796-9877 and (301) 796-9878
  • Web addresses:
    • DDMAC website
      • www.fda.gov/cder/ddmac
    • Warning and untitled letters
      • www.fda.gov/cder/warn
    • Guidances
      • www.fda.gov/cder/guidance