PharmExec Blog

Five Compliance Questions to Ask Yourself, from the DOJ

At CBI’s 10th Annual Pharmaceutical Compliance Congress, Maame Ewusi-Mensah Frimpong, deputy assistant attorney general, consumer protection branch, civil division, at the US Department of Justice, said being compliant means understanding people, and their motivations. Frimpong said non-compliance boils down to a failure of individuals, and offered five questions for chief compliance officers to ask themselves about their colleagues.

In addition to taking a close look at pharma’s internal processes, manufacturing facilities and corporate policies this year, the US Justice Department (DOJ) – in the name of “protecting consumers where they are most vulnerable,” according to Frimpong – is also placing a “focus on people,” since processes and policies (at least publicly-circulated processes and policies) don’t typically break the law; people do. “We know there are enormous cost pressures, but you can’t sacrifice safety under these pressures,” said Frimpong.

To that end, Frimpong recommended that attendees ask themselves five questions about the group of people they work with, to help identify potential problems before they result in an investigation or worse. In summary, Frimpong’s questions are:

1. Do we have the right people? Are they experts in their specific task areas? “People are not fungible,” said Frimpong. Given the complexity involved in certain manufacturing practices, for example, it’s crucial that the right person is working in the right role.

2. Do our people have the right incentives enabling them to see problems, report problems, and fix problems? Frimpong said strong internal communications are key to facilitating diligent compliance programs.

3. Are our people satisfied and engaged with the company and their jobs? Frimpong said the departure of key people can sometimes lead to lapses in compliance, citing SB Pharmaco, a GSK subsidiary, and the manufacturing deficiencies at the company’s (now-closed) plant in Cidra, Puerto Rico.

4. Are people and policies working in harmony? Companies should set realistic goals, and refrain from crafting compliance programs and procedures that can’t be met. Unrealistic standards are doomed to fail, said Frimpong.

5. Do we, as chief compliance officers, know what our people are actually doing? Given the size and scope of many large, multinational pharmas, it’s important that leadership make a concerted effort to communicate with and assess the performance of specific individuals whenever possible.

Frimpong underscored the problem – and gave examples – of companies who’ve put patients in harm’s way in service of the bottom line, saying, “when companies put profits over patients, everyone loses.”

Extra: For a report from Jill Wechsler on comments about the recent Caronia decision made by Tom Abrams, director of the Office of Prescription Drug Promotion, at the CBI Congress, click here.


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