Earlier this month, the largest settlement yet levied against a pharmaceutical company for illegal promotion of a drug was settled against Pfizer and its subsidiary Pharmacia & Upjohn Co. The $2.3 billion fine sanctioned the pharmaceutical company for promoting its painkiller Bextra for off-label uses. Similar charges concerning the drugs Zyvox, Geodon, and Lyrica were also made, along with allegations that the company provided kickbacks to healthcare professionals for prescribing these and other drugs. The settlement could affect continuing medical education providers who receive unrestricted educational grants from the firm.
As part of the agreement with the Department of Justice, Pfizer also was required to enter into a corporate integrity agreement (CIA) with the Office of Inspector General of the Department of Health and Human Services. The point, of course, is to ensure that the company puts procedures in place so that similar situations can be avoided, and, should they happen again, to ensure that they can be caught early and remedied. (Click here to download a copy of the 79-page Pfizer CIA.)
Among its many provisions are a few that should put CME providers that accept grants from the company on alert that their work will likely be closely scrutinized:
The term "Third Party Educational Activity" means any continuing CME, disease awareness, or other scientific, educational, or professional program, meeting, or event supported by Pfizer, including but not limited to, sponsorship of symposia at medical conferences…
Pfizer will develop a monitoring program for activities that are initiated, budgeted, and handled from Pfizer headquarters: 1) consulting arrangements, 2) publication activities, and 3) medical education grants and health care related charitable contributions submitted by MEG
It shouldn’t be too onerous, however.For the most part, the CIA appears to simply say that “Pfizer’s Policies and Procedures [must be] designed to ensure that Pfizer’s funding complies with all applicable federal healthcare programs and FDA requirements,” including disclosure of its financial support of a third-party educational activity and any financial relationships the company has with , speakers, and organizers. It also requires similar disclosures from those who receive Pfizer grants for CME activities.