The PhRMA Code that took effect January 1 increases regulatory compliance pressure on companies. Its newest provision is clear: Any entity engaged in drug promotion, including PR firms hired by companies, is accountable for upholding compliance when executing promotional tactics.
PR remains subject to intense regulatory scrutiny as the FDA and the Department of Justice (DOJ) take enforcement and legal actions against companies believed to be engaged in off-label promotion. Press releases in particular are ripe for enforcement, as they are publicly available on the Web. A release was the basis for a government settlement with InterMune and for its CEO's indictment. Files of PR and other communications firms have been and continue to be subpoenaed.
Not all PR pros are equipped for this change. Until now, there has been no standardized, systematic, and comprehensive training customized to PR. On the whole, regulatory thought leaders lack confidence in their firms' level of regulatory understanding. Interim survey results of regulatory decision-makers found that submission by PR pros of draft materials that need major revisions increases company risk and costs.
PR pros must make four shifts to address the current climate:
- Face the gap. The industry can't delay assessment of regulatory compliance literacy among PR pros.
- Reprioritize in today's economy. Belts are being tightened, so agency and corporate management must recognize regulatory compliance as a training priority. Sales reps are trained periodically on government requirements and voluntary codes. PR pros should follow suit.
- Cultivate a new culture. Firms must ask: Are we abdicating responsibility for regulatory compliance to our clients? Clients must decide whether to require their firms to invest in regulatory compliance training apart from company-provided information. Several pharma companies have done just that, recognizing the value of working with regulatory-savvy agency teams.
- Conduct a risk-benefit analysis. Must it take a client mandate or, worse, an indictment before firms take regulatory compliance seriously? This is hardly an optimal risk-management strategy. Whistleblowers increase everyone's vulnerability. There already have been billions in fines and personal indictments and the DOJ's position is that the industry is not doing enough.
PR agency leaders are embracing the need to share accountability with clients. Weber Shandwick's healthcare practice has committed to train and certify its US staff. Euro RSCG Worldwide PR will train one of its largest account groups. Boutique firm The Reilly Group requires everyone working with its pharma clients to train and certify. Lippe Taylor is among other firms taking part in compliance training.
What is the industry waiting for? It's time to set a new standard related to this issue – before one is set for us. Rules are constantly changing. The consequences of noncompliance are severe – for clients and, now, for their agencies. Noncompliance? Not on our watch! It's time for the PR profession to step up.
Ilyssa Levins is president of Center for Communication Compliance.