FDA Update on Advertising and Promotion of Prescription Drugs

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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

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Topics

• Policy Updates
• Enforcement Updates
• 2006 and beyond

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Policy Updates

• Direct-to-Consumer Promotion (DTC)
• Risk Information
• Guidance Development

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Risk Information

• Most common violation cited in DDMACs letters
• Important to public health
• American public entitled to balanced picture

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Risk Information

• Industry
• include serious and common risks
• cannot omit risk from promotion
• make efforts to better present risk info
• FDA
• taking necessary and appropriate enforcement
  actions
• working on draft guidance for risk info
  presentation

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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)

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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

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Types of Violations - Most Common

• Inadequate Risk Information - 82
• Misleading Effectiveness Claims - 43
• Misleading Comparative Claims - 43

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Targeted Audience

• Healthcare Professional Directed - 60
• Consumer Directed - 30
• Both HCP and Consumer Directed - 10

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Violations concerning Risk Information

• Nipent Warning Letter
• Survanta Warning Letter

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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

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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

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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

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Misleading Effectiveness Claims

• Quadramet Warning Letter

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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

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Quadramet Warning Letter

• Quadramet doesnt 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 wasnt drowsy.
• And I am surprised that she didnt sit here and
  cook a big meal for you guys.

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Misleading Comparative Claims

• Lumigan Warning Letter
• Remodulin Warning Letter

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Lumigan Warning Letter

• Sales aid
• Unsubstantiated superiority claims
• Weight of evidence proves LUMIGAN produces lowest
  mean IOP. For examplevs beta-blockers vs
  travoprost vs latanoprost vs dual therapy
• Lumigan produces lowest mean IOPvs dual therapy
• 14 to 27 greater mean IOP reduction than Cosopt

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Remodulin Warning Letter

• Journal ad and FAQ booklet
• Misleading comparative claims to Flolan
• Answer to How is Remodulin different than
  Flolan highlights advantages of Remodulins
  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

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Correctives

• Same audience and similar vehicle
• Correct misleading messages
• Examples print ad, DHCP letter

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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

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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

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DDMAC Information

• Phone numbers
• Phone - [phone]
• Fax - [phone] and [phone]
• Web addresses
• DDMAC website
• www.fda.gov/cder/ddmac
• Warning and untitled letters
• www.fda.gov/cder/warn
• Guidances
• www.fda.gov/cder/guidance