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Navigating FDA Compliance Changes: Strategies for Pharmaceutical Companies

Explore the evolving FDA compliance landscape and learn key strategies for ensuring marketing and regulatory compliance in the pharmaceutical industry. Discover insights on risk assessment, enforcement trends, and proactive measures to stay compliant.

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Navigating FDA Compliance Changes: Strategies for Pharmaceutical Companies

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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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