The pharmaceutical industry has paid more than $5 billion in fines over the last five years. To put things into perspective:
Money that went toward paying those fines could have been used to fund the development of four or five new drugs. At the same
time, half of all industry Corporate Integrity Agreements (CIAs) were spearheaded by a presettlement allegation (and subsequent
investigation) involving off-label promotion, while 80 to 85 percent of all CIAs addressed off-label promotions as one of
the major areas for companies to fix during their five-year journey with the government.
Yet over the last five years, drugmakers have gone through a major metamorphosis addressing off-label risks. The public may
not notice the difference for a few years since there are still big CIAs being negotiated following investigations that were
started six to eight years ago.
The industry has also paid dearly to its consultants and attorneys to revamp processes and policies, retrain employees, and
automate systems—all to avoid off-label promotion. New standard operating procedures (SOPs) have had to address the major
risk areas, ranging from sales, marketing, and medical to publications, speaker programs, and continuing medical education
(CME). These soft costs for these necessary changes have added another $1 billion to the off-label tab.
Now that the pharmaceutical industry has invested its energy and resources in avoiding inappropriate off-label practices,
it's worth assessing just how well they have worked in mitigating risks to compliance.
Off-Label Compliance in Real Time
For compliance managers, addressing off-label compliance while carrying out daily business can be as tricky as trying to fix
a plane in midair. After all, the key is to identify risks and take corrective action while the plane is still on the ground—and
before catastrophic accidents occur! Too often, compliance managers limit their focus to the design of their compliance programs
(policies, procedures, and training schedules) while neglecting the maintenance (evaluation, monitoring, and testing).
It should also be noted that FDA recently provided draft guidance on the topic of off-label promotion. The guidance suggests
ways in which medical journal articles on unapproved new uses of approved drugs may be disseminated; it also draws attention
to the fact that the industry needs to monitor these types of activities to ensure compliance. (For more info, see "New FDA
Regs for Off-Label Promotion?", or go to
New FDA Regs for Off-Label Promotion?
The high-level policies covering off-label communications are relatively straightforward. The challenge is that they impact
almost every element of business. In fact, most companies have more than 80 potential exposure points to off-label promotion
(see "Pharma's 80 Off-Label Risks"). The sheer magnitude of these risks makes compliance hard to address through policies
and procedures alone.
Pharma's 80 Off-Label Risks
In addition, how these rules and regs are operationalized likely varies from department to department, function to function.
Given this complexity, policy development, SOP design, and compliance training alone are unlikely to prevent inappropriate
off-label communication. Drugmakers must begin to use evaluation and monitoring techniques to identify potential issues before
they become financial problems.