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 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

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