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Compliance in the New Environment

Compliance in the New Environment. Wayne L. Pines August 25, 2005. Looking Ahead…. FDA preparing new guidance documents Help-Seeking/Disease Awareness Brief Summary Guidance Outdoor Media Presentation of Risk Information Electronic Submissions.

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Compliance in the New Environment

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  1. Compliance in the New Environment Wayne L. Pines August 25, 2005

  2. Looking Ahead… • FDA preparing new guidance documents • Help-Seeking/Disease Awareness • Brief Summary Guidance • Outdoor Media • Presentation of Risk Information • Electronic Submissions

  3. FDA Enforcement Priorities Will Remain Same • DTC • Launch materials • Exhibits • Competitor complaints • Lower priorities • CME • Peer-reviewed materials • Media materials • Meetings with healthcare professionals

  4. FDA’s Aggressive Enforcement Stance • On record pace this year for warning letters • Key issues: over-promotion of benefits, risk minimization • More aggressive corrective measures • Corrective advertising

  5. Every Company Has Risk Quotient • FDA enforcement is uneven • Marketplace is very competitive • Each company must assess benefits and risks • How many letters/violations? • How much publicity? • In the new environment, the benefit-risk ratio of taking risks has changed • Scrutiny more focused, penalties more severe

  6. What Companies Can Do • Productive marketing is possible within the rules • Aggressively promote approved claims • Use all communication vehicles • Can educate about “unapproved” uses: • Sponsoring appropriate CME • Channeling requests to Medical Affairs • Releasing legitimate research results

  7. What CompaniesShould Have in Place • SOPs for • Internal clearance of materials and promotional programs • System for submitting materials to FDA at time of first use • Plan for submitting launch materials to FDA for review • Training programs to assure compliance • Culture of compliance

  8. Predictions • Upsurge in warning letters will continue • Politics of drug safety and DTC will drive enforcement attitude • “Off-label” challenge from other sources – OIG/US Attorneys – will continue • FDA remains the resource, sometimes the instigator, of enforcement by agencies with more punitive tools • A year of change in the marketing/regulatory world

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