Pharmaceutical company best practices should include a focus on drug pricing
issues as well as promotional activities, a Department of Health and Human
Services Office of Inspector General official said during a conference Nov.
Pharmaceutical companies should pay extra attention to how they calculate
drug prices, as well as how they report pricing information, Mary Riordan,
senior counsel in the OIG's Office of Counsel, said during the Pharmaceutical
Regulatory and Compliance Congress and Best Practices Forum.
She also said companies should implement a centralized risk assessment
program and maintain flexible and effective audit practices.
Riordan said OIG expects to audit several manufacturers in 2013 regarding
their drug pricing policies.
She also recommended that companies maintain effective oversight of
promotional activities involving drugs, such as the use of coupons and related
payments to physicians and individuals.
Riordan was joined by Gregory Demske, chief counsel to the HHS Inspector
General, who spoke of the importance of corporate integrity agreements (CIAs) in
For example, Demske said the CIA that GlaxoSmithKline entered into in July in
conjunction with its $3 billion settlement contained a provision prohibiting the
company from compensating sales staff based on the volume of their sales (127
Instead, sales compensation will be based on customer evaluations and sales
“We think it's a significant move for the company, and it's moving them
toward aligning with the theme of paying for outcomes as opposed to paying based
on volume,” Demske said.
Demske also said the CIA included a “clawback” provision, enabling the
company to take back bonuses that were made to executives who engaged in any
In addition to her best practice recommendations, Riordan discussed a number
of themes that emerged from a roundtable OIG held in February with 23
pharmaceutical companies operating under corporate integrity agreements.
She said the five main themes from the roundtable included:
and monitoring risk areas;
and procedures on employee training; and
activities after the CIA ends.
The OIG issued a report
on the roundtable in March (58 HCDR, 3/27/12).
By James Swann