Transcript Regulation of Drug Marketing Introduction to Drug Law and

Regulation of Drug Marketing
Introduction to Drug Law and Regulation
FDLI Workshop
April 28-29, 2003
Teaneck, New Jersey
Philip Katz
Crowell & Moring LLP
1001 Pennsylvania Avenue, NW
Washington, DC 20004
(202) 624-2660
[email protected]
Drug Marketing
• Advertising
• Labeling
• Other activities/statements
• Sales force
• Press releases
• Securities filings
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Drug Marketing
• Advertising
• Not well defined
• Labeling
• Label and “all other written, printed or
graphic matter . . . accompanying” the
drug
• “Accompanying” defined broadly
3
Drug Marketing
• Misbranded drugs
• False or misleading labeling
• Labeling lacks required information
• Labeling lacks adequate directions for
use or adequate warnings
• Rx drug advertising lacks brief summary
4
Drug Marketing
• False or misleading labeling and
advertising
• “Misleading” includes material omissions
• Promoting unapproved uses
• Inadequate brief summary
• Lacking in fair balance
5
Drug Marketing
• Unapproved new drugs
• Defined by intended use
• Look to advertising/labeling claims,
statements, knowledge of other uses
• Includes off-label uses of approved drugs
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Drug Marketing
• Unapproved new drugs
• Reporting clinical trial results
• Press releases
• Securities filings
• Describing narrow indications
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Drug Marketing
• Brief summary
• True statement of information in brief
summary relating to side effects,
contraindications, and effectiveness
• Exception for reminder ads
• Exception for broadcast ads
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Drug Marketing
• Brief summary
• Side effects, contraindications broadly
defined
• Information must be specific
• Can’t fix false or misleading statements
elsewhere in ad
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Drug Marketing
• Fair balance
• Part of “true statement” in brief summary
• Balance between information about
effectiveness and that regarding side
effects, contraindications
• Look to scope, depth and detail of
information
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Drug Marketing
• Lack of fair balance
• Inadequately supported effectiveness or
safety claims
• Comparative claims not demonstrated by
substantial evidence or substantial
clinical experience
• Selective, unrepresentative use of
information
11
Drug Marketing
• Reminder advertising
• No need for brief summary
• No representation or suggestion
concerning safety, effectiveness or
indications
• Price ads only, if drug has boxed warning
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Drug Marketing
• Broadcast advertising
• Information relating to major side effects
and contraindications in audio or audio
and visual parts of presentation
• Exempt from brief summary if “adequate
provision” made for disseminating
approved labeling
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Drug Marketing
• August 1999 guidance on “adequate
provision”
• Toll-free number for access to labeling
• Print ads or brochures
• Website address
• “See your doctor for more info”
14
Drug Marketing
• FDA enforcement
• Untitled letters or warning letters
• Stop using the material
• Corrective communications
• Penalties for FDCA violations
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Drug Marketing
• FTC enforcement
• OTC drug advertising
• Different perspective, process, and
results than FDA
• Focus on false or misleading
representations
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Drug Marketing
• FTC enforcement
• Identify the representation
• Determine whether it’s true and
substantiated
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Drug Marketing
• Identifying the representation
• Express and implied claims
• Intent irrelevant
• Reasonable interpretation by target
audience
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Drug Marketing
• Truth and substantiation
• Implied presence of substantiation
• “Establishment” claims
• True + false = false
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Drug Marketing
• Prescription Drug Marketing Act
• Drug sample distribution
• Written request from licensed practitioner
• Requirements re request, receipt,
verifying prescribing authority, inventory
reconciliation, systems to prevent
diversion, record-keeping
• Significant penalties for violations
20
Drug Marketing
• Issues of practical application
• First Amendment
• Direct-to-consumer promotion
• Internet
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Regulation of Drug Marketing
Introduction to Drug Law and Regulation
FDLI Workshop
April 28-29, 2003
Teaneck, New Jersey
Philip Katz
Crowell & Moring LLP
1001 Pennsylvania Avenue, NW
Washington, DC 20004
(202) 624-2660
[email protected]