Executive Briefing Series (formerly The Food & Drug Letter)

Pharmaceutical sales forces have expanded rapidly in recent years, but reductions in the time physicians are willing to spend with sales representatives combined with the increased risk of prosecution and civil litigation stemming from sales and marketing practices are making it difficult for drugmakers to balance rising sales expenses. If sales reps can’t meet with physicians or aren’t effective in promoting products, sales will suffer. If reps adopt tactics that violate false claims or antikickback statutes, legal costs and settlements can take a major bite out of earnings and subject the company to ongoing oversight and reporting requirements. This issue of FDL examines Rx sales training strategies to mitigate legal and regulatory compliance risk while turning challenges into opportunities to effectively communicate product benefits to physicians.

The average length of time a pharma sales representative gets to spend with a physician on a sales call has dropped below two minutes, according to figures from BioPharma Consultants, and government guidance and enforcement patterns suggest many traditional sales and marketing practices are becoming high-risk.

Justice Department officials have recently notified both Pfizer and Eli Lilly that their sales and marketing practices are under investigation.

Even the best company policies and strongest training programs can’t guarantee a drugmaker won’t have the proverbial rogue sales representatives in its sales force.

One approach pharma sales representatives can use to improve their chances of getting past receptionists to speak directly to doctors is to become a source of information and advice on running a medical practice.

Enforcement officials already view sampling as part of an “out of control” pharma approach to marketing.

With the Justice Department and HHS' Office of Inspector General scrutinizing off-label communications for false claims and fraud implications, permitting sales representatives to respond to off-label inquiries from physicians is even more risky than it was when the pharma industry only had the FDA to worry about.

When traditional sales calls fail to achieve the desired results, or when reps find it difficult even to obtain a meeting with a physician, it may be time to change tactics and adopt alternative or complementary programs, according to two pharma marketing experts.

Although average sales prices (ASPs) won’t be used to calculate Medicare Part B drug reimbursements until next year, physicians are already asking pharma sales representatives about the new manufacturer-reported figures.