Healthy Skepticism Library item: 10156

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: report

Staff of the Committee on Finance
Use of Educational Grants by Pharmaceutical Manufacturers
Washington, DC: United States Senate 2007 Apr
http://web.archive.org/web/20110111193718/http://www.acme-assn.org/home/prb042507a.pdf

Abstract:

Executive Summary

The United States Senate Committee on Finance (Committee) has exclusive jurisdiction over the Medicare and Medicaid programs. Accordingly, the Committee has a responsibility to protect the safety and well-being of the more than 80 million Americans who receive health care coverage under Medicare and Medicaid, as well as a responsibility to all Americans to ensure that program funds are spent properly. In recent years, Medicaid payments for prescription drugs have grown faster than any other area of the Medicaid program. With the addition of the outpatient prescription drug benefit to the Medicare program in 2006, Federal spending on prescription drugs became even more substantial. Therefore, drug marketing and utilization patterns are of great concern to the Committee.

Pharmaceutical manufacturers fund educational programs that physicians and other health care workers attend, including some used to fulfill their licensure requirements. In 2005, the Committee staff became aware through reports that pharmaceutical companies were routinely using educational grants to help build market share for their newer and more lucrative products. This raises two primary concerns. First, new products tend to be more expensive than older products, thereby increasing total program spending. Second, new products have less clinical history, and may expose patients to greater risks than older products with better established safety and efficacy.

Beginning in June 2005, the Committee wrote to the 23 largest pharmaceutical manufacturers to inquire about their use of educational grants and subsequently sent questions to the Accreditation Council for Continuing Medical Education (ACCME), the primary accrediting body for continuing medical education (CME) for physicians. The Committee staff reviewed answers from the pharmaceutical manufacturers and the ACCME, as well as reports published in journals and the popular press and other publicly available data.

In reviewing enforcement actions by Federal agencies, and reports in the popular press and medical journals, the Committee staff found that drug companies have used educational grants as a way to increase the market for their products in recent years. This practice is of particular concern when the companies use educational grants to encourage physicians to prescribe products for uses beyond their Food and Drug Administration (FDA) approval. Based on the Committee staff’s review of responses from the pharmaceutical manufacturers, it appears the manufacturers have implemented policies meant to rein in these activities. The companies have taken steps to separate the grant-making process for educational programs from their marketing efforts. In addition, various industry groups and government agencies have created guidelines for educational grants to reduce the potential for abuse. Drug companies, however, are not mandated to follow the guidelines and a significant gray area continues to exist regarding the use of educational grants to serve marketing purposes.

Indeed, ACCME’s records reveal numerous cases over the past 3 years in which companies had too much influence over the content of supposedly independent educational programs. In one case, a CME provider was cited for allowing a company to help select presenters; in another, the company allegedly influenced the setting and frequency of educational events. One CME provider was cited for promoting the ‘‘proprietary business interests of a commercial interest’’ during an educational program. During 2005 and 2006, 18 of the 76 CME providers reviewed by ACCME-or 24 percent-did not comply with at least one of the standards meant to ensure independence.

Another continuing concern for the Committee staff is the lack of proactive or real time oversight for educational grant programs. CME providers are not required to run prepared text by the FDA, ACCME, or any regulatory authority in advance of CME programs, and the FDA and ACCME do not routinely place monitors in CME audiences to assess what information is presented. Both the FDA and ACCME have intervened after the fact when presented with evidence that abuse occurred in educational grant programs. They do not, however, pre-approve or directly monitor educational grant programs and oversight actions may occur long after the problematic educational activity occurred. Even when ACCME determines that the CME providers repeatedly failed to distance themselves from the drug companies that sponsor them, ACCME can take years to impose penalties. Based on ACCME policies, it can take as long as 9 years from the date of a non-compliant educational activity for an educational provider to lose accreditation.

C O N T E N T S
Page
I. Executive Summary ……………………………………………………………………………… 1
II. Introduction …………………………………………………………………………. 2
III. Scope and Methodology ………………………………………………………………………….. 4
IV. Background …………………………………………………………………………… 5
Off-Label Use …………………………………………………………………………………. 5
Partners in Compliance and Oversight ……………………………………………………. 5
Food and Drug Administration …………………………………………………………… 5
Departments of Justice and Health and Human Services ……………………………………… 7
Pharmaceutical Research and Manufacturers of America ……………………………………… 8
Consumers ……………………………………………………………………………. 8
V. Discussion …………………………………………………………………………… 9
General Funding Statistics …………………………………………………………….. 9
Accreditation ………………………………………………………………………… 9
Policies and Procedures for Awarding Grants …………………………………………….. 10
Clinical Practice Guidelines ………………………………………………………….. 11
Policies for Accrediting Educational Providers ………………………………………….. 12
VI. Observations ………………………………………………………………………… 15
VII. Considerations ………………………………………………………………………. 16
Kickbacks …………………………………………………………………………… 17
Veiled Advertising …………………………………………………………………………. 17
Bias in Clinical Protocols ……………………………………………………………. 17
Off-label Promotion …………………………………………………………………………… 18
Appendix A-Accreditation Council for Continuing Medical Education (ACCME) 2004 ‘‘Standards for Commercial Support: Standards to Ensure the Independence of CME Activities’’ ………………………………………………………………………… 19
Appendix B-Health and Human Services Office of Inspector General (HHS OIG) 2003 ‘‘Compliance Program Guidance for Pharmaceutical Manufacturers’’ ……………………………………………………………………… 25
Appendix C-Pharmaceutical Research and Manufacturers of America (PhRMA) 2002 ‘‘Code on Interactions With Healthcare Professionals’’ ……………………………………………………….. 41
Appendix D-Food and Drug Administration (FDA) 1997 ‘‘Guidance for Industry: Industry-Supported Scientific and Educational Activities’’ ………………………………………………… 97

Notes:

Full report is a 4.71 MB .pdf file