- 8 Keys to Compliance for Medical Science Liaisons -- Part I
- March 2, 2007 | Authors: Leslie M. Werlin; Gretchen E. Townshend
- Law Firms: McGuireWoods LLP - Los Angeles Office ; McGuireWoods LLP - Chicago Office
Life science companies are increasingly utilizing the scientific expertise of Medical Science Liaisons (“MSLs”) to conduct educational and scientific discussions with health care professionals. Simultaneously, the Office of Inspector General of the Centers for Medicare and Medicaid Services (“OIG”) continues to scrutinize how life science companies promote and market their products. In this environment, all life science companies should focus attention on MSL compliance. For better or for worse, the FDA and OIG have established very little direct regulation applicable to MSL activities. The following keys to compliance, however, are gleaned from the laws and regulations generally applicable to the promotion of pharmaceuticals and medical devices.
A manufacturer’s sales force may promote an approved drug “on label” only. FDA has recognized, however, the importance of supporting educational discussions and the full exchange of scientific information between life science companies and physicians, discussions that may include information on unapproved uses. Because most MSL activities are not “promotional” in nature, such activities are not restricted by FDA rules and regulations regarding promotion of an approved product. MSLs are typically scientific or medical professionals with advanced degrees, retained by pharmaceutical companies for the purpose of conducting scientific and educational discussions with health care professionals. A company’s MSL team is the front line of this regulatory tension between promotion and scientific discussion. The following keys to compliance will help guide a MSL team to prevent critics from alleging that it has slipped into the prohibited territory off-label promotion or breached other regulations.
1) Establish Standard Operating Procedures and Provide the MSL Team With Clear Guidance
A life science company’s MSL team is in the field on a daily basis, interacting directly with health care professionals. Hence, monitoring the MSL team’s compliance with regulations is much more difficult than monitoring communications that come directly from the company. Therefore, a manufacturer may want to establish Standard Operating Procedures (“SOPs”) that outline clear and understandable guidelines for MSLs. Among topics that SOPs could beneficially speak to: (a) interactions with the sales force, (b) off-label communications and distribution of off-label materials, (c) interactions with the company’s investigator-initiated trial program, and (d) continuing medical education events. Without clear guidelines, MSLs must wade through the unclear and confusing regulations to decide what is appropriate in various situations.
2) Correctly Align MSL Reporting Responsibility
Although the OIG has not created any regulatory or legal requirements that dictate MSL reporting responsibilities, a company may wish to have its MSL team report to the company’s Medical Affairs and Research and Development Departments. As scientific and health professionals, MSLs often have the greatest affiliation with these departments. If MSLs report to marketing, sales or another division of the company’s commercial organization, critics may mischaracterize the MSLs’ tasks while in the field. In contrast, responsibility to Medical Affairs/R&D more clearly evidences the MSL’s purpose in promoting scientific discussions.
3) Establish Standard Operating Procedures for Dissemination of Off-Label Information
Regulation of the dissemination of off-label information has fluctuated over the past decade. The FDA originally promulgated guidance on dissemination of off-label information in 1996. The Washington Legal Foundation (“WLF”) successfully challenged this guidance, which in 1998 was found to be an unconstitutional restraint on speech. Wash. Legal Found. v. Friedman, 13 F. Supp. 2d 51 (D.D.C. 1998). In 1997, Congress passed the Food and Drug Administration Modernization Act (FDAMA) which did permit distribution of off-label article and journal reprints, but placed a variety of onerous conditions on manufacturers such as pre-distribution submission to the FDA. The WLF was again successful in challenging these regulations as unconstitutional. Wash. Legal Found. v. Henney, 202 F.3d 331 (D.C. Cir. 2000). The FDA has since agreed to treat the FDAMA conditions as a “safe harbor” instead of a requirement. Recently, the InterMune Corporate Integrity Agreement (“CIA”) reinforced the FDA’s guidance on distribution of off-label information. Companies should analyze their off-label dissemination policies to ensure that the policies address activities conducted by the MSL team and incorporate the latest FDA guidance and WLF principles.
4) Routinely Examine MSL Compensation Methodologies
When investigating the promotional activities of a manufacturer, prosecutors have started to look increasingly at the company’s business projections and compensation methodologies. James Sheehan, Associate U.S. Attorney in Philadelphia, a staunch critic of many life science industry practices, recently stated: “In my experience, business plans are not only there just to predict. Business plans are metrics. They’re there to drive where you are going to focus your attention and effort, where are you going to focus your attempt to achieve results.” Because of the sharper focus on these business plans, pharmaceutical companies need to be aware of the implications of their own “internal” documents. Potentially problematic methodologies include aggressive MSL business plans, or situations where a MSL appears to be heavily rewarded based on territory sales figures, growth of off-label prescriptions or other metrics that critics might allege to be improper. Hence, companies should review these methodologies and business plans and eliminate any metrics that critics could say improperly award MSLs for questionable conduct.