Transcript pines_4
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 FDA Enforcement Priorities Will Remain Same • • • • DTC Launch materials Exhibits Competitor complaints • Lower priorities – CME – Peer-reviewed materials – Media materials – Meetings with healthcare professionals 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 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 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 What Companies Should 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 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