A CIA first: mandatory de-link in sales force pay

Most startling, perhaps, is the provision requiring GSK to cut the link between sales rep pay and how much they sell. "The GSK CIA is very significant because it does address the issue of financial incentives for individuals within [GSK], in a way that we have not done in the past," says Demske. "There are two major ways that we do that: one is compensation for sales people; GSK's current system breaks the tie between sales person compensation and the volume of business that they're generating, and the second part is the claw-back provision."

With respect to sales rep compensation structures, government has been gnawing on this idea for a few years. Since 2008, Pfizer, Novartis, Merck, AstraZeneca, Johnson & Johnson, Lilly, Abbott, Novo Nordisk, Allergan, and Forest Labs—to name a few—all signed CIAs that directly addressed the issue of sales rep pay as it relates to potentially incentivizing off-label promotion. The GSK CIA, however, is the first time rep compensation based on sales volume has been outlawed entirely.

"The idea is to try to change the financial equation for people at the sales level and the executive level, so the executive isn't just thinking, 'Well, the more profits that are generated, the more bonus I get,' but also thinking, 'If I cross the line, I may have some of my money on the line, and I may lose that bonus, and maybe even more than that,'" says Demske. Sir Andrew Witty, GSK's CEO, wouldn't go broke if he had to give back three year's pay, but "in our analysis, nothing can damage a company's value more than a significant compliance enforcement action," says Ginor. "With a CIA, essentially for five years, the government is running your company."

"Dear Payer" and other CIA firsts

There are other completely new provisions in Glaxo's CIA. Mary Riordan, senior counsel, office of counsel to the inspector general, points to an expansion of the famous "Dear Doctor" program that requires a pharma company working under a CIA to send out a letter notifying physicians about the settlement. "This CIA goes one step further...there's also a requirement that [GSK] send a letter to payers, government, and other payers with which the company has rebate agreements, to notify the payers about the settlement," says Riordan. "Part of the purpose of that provision is to really focus the company's attention on the relationship that GSK has with government payers." Government payers, including Medicare and Medicaid, represent around half of Big Pharma's revenues.

In addition to the provisions cited above, other CIA requirements "reflect what GSK was already doing," says Riordan, like restrictions on the way funding is provided to third party medical education organizations, and the criteria for determining which organizations are eligible. Another example, unique to GSK's CIA, requires that a physician—if requesting off-label information from a rep—sign a form stating that the request was unsolicited. This is an example of a program already instituted by GSK, but reinforced by the mandate of a CIA. "That provision is part of a broader section [III.B.3] that talks about policies and procedures that the company has to maintain," says Riordan. "We were sort of memorializing and binding GSK to abide by those policies and procedures during the course of the CIA," which lasts through June of 2017.

This enshrining of internal compliance programs and policies is often the result of a typically long and protracted negotiation between pharma and government, prior to a settlement. Ginor says companies can derail enforcement actions before they escalate, by bending over backward to show that a problem is being adequately addressed. An apology letter from a CEO won't cut it. "It is escalation versus negotiation...government does not feel that they are your consultants," says Ginor. It's better to spend a little extra money on compliance programs at the outset, in good faith, than to spend a whole lot more later on, after the Justice Department steps up on its soapbox, says Ginor.