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Regulation of Drug Marketing
Introduction to Drug Law and RegulationFDLI Workshop
April 28-29, 2003Teaneck, New Jersey
Philip KatzCrowell & Moring LLP1001 Pennsylvania Avenue, NWWashington, DC 20004(202) [email protected]
2
Drug Marketing
• Advertising
• Labeling
• Other activities/statements• Sales force• Press releases• Securities filings
3
Drug Marketing
• Advertising
• Not well defined
• Labeling
• Label and “all other written, printed or graphic matter . . . accompanying” the drug
• “Accompanying” defined broadly
4
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
5
Drug Marketing
• False or misleading labeling and advertising
• “Misleading” includes material omissions
• Promoting unapproved uses
• Inadequate brief summary
• Lacking in fair balance
6
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
7
Drug Marketing
• Unapproved new drugs
• Reporting clinical trial results
• Press releases
• Securities filings
• Describing narrow indications
8
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
9
Drug Marketing
• Brief summary
• Side effects, contraindications broadly defined
• Information must be specific
• Can’t fix false or misleading statements elsewhere in ad
10
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
11
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
12
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
13
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
14
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”
15
Drug Marketing
• FDA enforcement
• Untitled letters or warning letters
• Stop using the material
• Corrective communications
• Penalties for FDCA violations
16
Drug Marketing
• FTC enforcement
• OTC drug advertising
• Different perspective, process, and results than FDA
• Focus on false or misleading representations
17
Drug Marketing
• FTC enforcement
• Identify the representation
• Determine whether it’s true and substantiated
18
Drug Marketing
• Identifying the representation
• Express and implied claims
• Intent irrelevant
• Reasonable interpretation by target audience
19
Drug Marketing
• Truth and substantiation
• Implied presence of substantiation
• “Establishment” claims
• True + false = false
20
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
21
Drug Marketing
• Issues of practical application
• First Amendment
• Direct-to-consumer promotion
• Internet
Regulation of Drug Marketing
Introduction to Drug Law and RegulationFDLI Workshop
April 28-29, 2003Teaneck, New Jersey
Philip KatzCrowell & Moring LLP1001 Pennsylvania Avenue, NWWashington, DC 20004(202) [email protected]