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. 5.
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 promoting compliance.
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 HCDR, 7/3/12).
Instead, sales compensation will be based on customer evaluations and sales competency.
“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 misconduct.
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:
• CIA implementation challenges;
• compliance program structure;
• identifying and monitoring risk areas;
• policies and procedures on employee training; and
• compliance activities after the CIA ends.
The OIG issued a report on the roundtable in March (58 HCDR, 3/27/12).
By James Swann
All Bloomberg BNA treatises are available on standing order, which ensures you will always receive the most current edition of the book or supplement of the title you have ordered from Bloomberg BNA’s book division. As soon as a new supplement or edition is published (usually annually) for a title you’ve previously purchased and requested to be placed on standing order, we’ll ship it to you to review for 30 days without any obligation. During this period, you can either (a) honor the invoice and receive a 5% discount (in addition to any other discounts you may qualify for) off the then-current price of the update, plus shipping and handling or (b) return the book(s), in which case, your invoice will be cancelled upon receipt of the book(s). Call us for a prepaid UPS label for your return. It’s as simple and easy as that. Most importantly, standing orders mean you will never have to worry about the timeliness of the information you’re relying on. And, you may discontinue standing orders at any time by contacting us at 1.800.960.1220 or by sending an email to email@example.com.
Put me on standing order at a 5% discount off list price of all future updates, in addition to any other discounts I may quality for. (Returnable within 30 days.)
Notify me when updates are available (No standing order will be created).
This Bloomberg BNA report is available on standing order, which ensures you will all receive the latest edition. This report is updated annually and we will send you the latest edition once it has been published. By signing up for standing order you will never have to worry about the timeliness of the information you need. And, you may discontinue standing orders at any time by contacting us at 1.800.372.1033, option 5, or by sending us an email to firstname.lastname@example.org.
Put me on standing order
Notify me when new releases are available (no standing order will be created)