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) 624-2660pkatz@crowell.com

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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

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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

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Drug Marketing

• False or misleading labeling and advertising

• “Misleading” includes material omissions

• Promoting unapproved uses

• Inadequate brief summary

• Lacking in fair balance

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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

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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”

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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

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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) 624-2660pkatz@crowell.com