Post-DoJ settlement, GlaxoSmithKline toes the line in Breo launch

Does the Justice Department's off-label marketing enforcement actually deter bad behavior? That's been up for debate as one drugmaker after another agreed to pay hundreds of millions of dollars to settle federal investigations--some of them repeat offenders.

For instance, Johnson & Johnson ($JNJ) this week agreed to pay $2.2 billion to wrap up its Risperdal marketing probe. But the antipsychotic drug brought in many times that amount over the years before it went off patent. Worried that even billions in fines and civil penalties aren't having the desired effect, some officials have pushed for individual prosecution of executives involved--even top execs who may not have known about the shenanigans.

Some drugmakers appear to be changing their behavior, though, Bloomberg reports--not out of the goodness of their hearts, but out of self-interest.

GlaxoSmithKline ($GSK), in the midst of launching its new respiratory drug Breo Ellipta, has been hammering on the drug's potential side effects in presentations to doctors, the news service reports. Last year, the company forked over $3 billion to wrap up a variety of off-label marketing and other probes--including allegations that it promoted its older lung drug, Advair, for uses not approved by the FDA and withheld safety data on the drug as well.

A lot is riding on Breo's success; GSK collected more than $7.7 billion in Advair sales last year, and because the drug is off patent, generic competition in the U.S. could hit anytime a rival succeeds in winning approval. That's not likely for a couple of years, so the company has time to build up its new respiratory drugs in the meantime--including Breo.

In the past, that need to succeed might have inspired some envelope-pushing sales tactics. But these days, it's not all about the benefits of a drug, according to James Donohue, a medical professor paid by GSK to speak at a recent Breo promotional meeting. "With the old way we did things, you emphasized the efficacy and benefits," Donohue told Bloomberg. "At the end, you'd always include the safety, but you just brushed over it. Now there's a huge emphasis on the side effects."

Glaxo has made a series of moves to polish its tarnished reputation, including changing its compensation system for sales reps, opening up some research data, capping payments to doctors and cutting prices in poor countries. But an investigation into corruption in China--including allegations of up to $490 million in bribes--hasn't helped. According to Bloomberg, CEO Andrew Witty says he's thinking of making sales-compensation changes in other countries now--including China. That's a bit like closing the paddock door after the horse escaped, but it might keep others inside the fences.

Meanwhile, Bloomberg says, other drugmakers are also hammering home the risks of their new drugs. It's almost inescapable in the age of online information, one expert told the news service: "Selling as a practice in most industries means just giving the good news and leaving out the bad," consultant Bill Lee said. "Buyers have the power now. They can easily go to the Internet and get pretty much all the information they need."

- read the Bloomberg story

Special Report: Pharma's Top 11 Marketing Settlements - GSK - J&J