In good times and bad, healthcare talent is hard to find. Agency demand for individuals with proven records of navigating the regulatory minefield of the FDA far exceeds supply. Clients are increasingly intolerant of inexperienced people working on their business, in any capacity. For healthcare companies, the risks of non-compliance are simply too high.
A study published in May by Rx Compliance Report asked drug and device company regulatory executives to assess risks and activities of their so-called “promotional agencies.” Though the sample is small at about 60, some 90% of respondents said they believe communications agencies are not “sufficiently knowledgeable about regulatory considerations.” Of major concern, according to the piece, is the amount of wasted time and resource that results from materials that have to be reworked.
Ilyssa Levins, who spent 30 years in healthcare at Grey Global Group, launched a firm specializing in training professionals called Center for Communication Compliance. Levins emphasizes that agencies not focusing on this issue will lose out in more ways than one. Agencies, she says, are not immune from prosecution, though there hasn't yet been a test case. Redoing materials cuts into profit margins and jeopardizes big pieces of business. It also diverts resources away from new business and other growth activities.
Levins also warns that there is a creative cost. “When programs are submitted that are so far out of compliance, they get thrown out immediately,” she says. “Agencies are losing potential revenue because big ideas that might earn them more fees are getting killed.” Understanding the regulatory limitations and landscape will offer agencies an opportunity to walk their clients through scenarios for success with even more edgy campaigns.
That level of account management finesse is only possible for those truly conversant in this increasingly torturous environment. Talented healthcare PR pros will seek out organizations that will give them the opportunities to train and become fluent in these areas. Given the never-ending search for healthcare experts, that threat alone may be enough to make agencies take notice.