GUEST COMMENTARY

How MSLs Can Help Get Biopharma’s Groove Back
By Rick Keefer

An August 2009 Gallup poll found that a paltry 31% of U.S. adults held a positive opinion of the pharmaceutical industry (tied with Utilities and Advertising, and just behind Airlines, at 32%).¹ Unfortunately, it’s not only average citizens who hold us in low esteem; many physicians do as well. To appreciate their level of anti-pharma sentiment, see the May 2009 Archives of Internal Medicine editorial “Time for the Medical Profession to Act: New Policies Needed Now on Interactions Between Pharmaceutical Companies and Physicians.”² The bottom line: We’ve got to find ways to rebuild our industry’s reputation.

One way we can regain and retain physicians’ respect is through the work of Medical Science Liaisons (MSLs). In many cases, MSLs represent the highest-level interaction we have with physicians, especially researchers and KOLs. MSLs are—and should be—respected within the medical community as a credible resource for clinical information; they are in demand,³ they author articles in peer-reviewed medical and pharmacy journals,^4,5 and they are even the subject of career-choice books.^6,7

What steps can we take to ensure that MSLs are viewed by physicians as trusted members of the healthcare team? We can start by giving them the tools they need to do their work expertly and in full compliance with applicable laws, regulations, and established conventions. A legal update on law firm McGuireWood’s Website sets out 8 strategies to do just that.⁸ I’ve listed them below, along with additional thoughts on each:

Establish Interaction SOPs. Provide the MSL team with clear guidance and SOPs for key interactions, including with physicians and clinical investigators, with sales and marketing staff, and at medical education programs.

Correctly Align MSL Reporting Responsibility. Build firewalls that adequately separate MSLs from sales, marketing, and other commercial functions. In many companies, MSLs report to the Medical Affairs or R&D departments.

Establish SOPs for Responding to Requests for Off-Label Information and Materials. Generally speaking, MSLs should not proactively disseminate off-label information. Ensure that SOPs clearly spell out the conditions for proactive visits to physicians and the rules of engagement for responsive communications. Watch closely for ongoing FDA guidance, and make sure your policies are up-to-date, MSL-specific, and clearly communicated to staff.

Routinely Examine Compensation Methodologies. MSL compensation models are an increasingly important point of focus for compliance audits. MSLs should never be compensated based on any sales metric. Avoid problematic compensation models that may seem to reward MSLs for improper conduct.

Create Guidelines for Information Exchange on Unapproved Drugs. MSLs should understand FDA rules regulating the representation of investigational new drugs. In discussions with clinicians and investigators, they should provide fair-balanced information regarding pipeline products. Clear rules of engagement should be established covering proactive communications during the critical prelaunch phase of a new drug.

Review Interactions Between Sales Force and MSLs. MSLs are not “promotional tools” available to supplement the sales team. Establish and enforce clear guidelines governing the manner in which MSLs and the sales/marketing teams interact.

Create Guidance for Interactions Between MSLs and Investigator-Initiated Trial Programs. In their interactions with investigators and KOLs, MSLs should avoid suggesting ideas for new trials. Furthermore, MSLs should not encourage excessive or redundant trials.

Avoid Involvement of MSLs in a Direct Promotional Context. MSLs should never be involved in direct promotion or a “selling” situation. Institute MSL-specific codes of conduct that reflect current compliance guidelines, legal and regulatory requirements, and company standards.

According to our Chief Compliance Officer, Richard Lev, JD, this 8-step plan “provides an excellent starting point for maintaining a professional, high-integrity MSL force.” These recommendations align well with the guidelines we’ve implemented for contract MSLs on behalf of clients.

In the end, our ability to repair our industry’s tarnished image depends in part on our determination to protect the professional role of MSLs. This is a fight we must win. (To comment, you can email the author at RickK@pSellingSolutions.com.)

REFERENCES
1. http://www.gallup.com/poll/122342/Automobile-Banking-Industry-Images-Sli.... Accessed August 25, 2009.
2. Greenland P. Time for the Medical Profession to Act: New Policies Needed Now on Interactions Between Pharmaceutical Companies and Physicians. Arch Intern Med. 2009 May 11;169(9):829-31.
3. http://jobsearch.monster.com/Search.aspx?vw=b&yellowinter=1&rad=20&rad_u.... Accessed September 8, 2009.
4. Kupferer EM, Dormire SL, Becker H. Complementary and alternative medicine use for vasomotor symptoms among women who have discontinued hormone therapy. J Obstet Gynecol Neonatal Nurs. 2009 Jan-Feb;38(1):50-9.
5. Rojas-Fernandez CH, Moorhouse P. Current concepts in vascular cognitive impairment and pharmacotherapeutic implications. Ann Pharmacother. 2009 Jul;43(7):1310-23. Epub 2009 Jul 7.
6. Malecha SE. Bridging Scientific Knowledge: The Role of the Medical Science Liaison. Bloomington, IN: AuthorHouse; 2009.
7. Albert E. The Medical Science Liaison: An A to Z Guide. Bloomington, IN: AuthorHouse; 2007.
8. Werling KA, Townshend GH. 8 Keys to Compliance for Medical Science Liaisons. Part 1: http://www.mcguirewoods.com/news-resources/item.asp?item=2397. Part 2: http://www.mcguirewoods.com/news-resources/news/2413.asp. Accessed August 25, 2009.

Rick Keefer is President and CEO of Publicis Strategic Solutions Group.

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