Legal Updates

2/26/2007

8 Keys to Compliance for Medical Science Liaisons - Part 2

This article is part two of a two-part series focusing on Medical Science Liaison or “MSL” compliance. For the first article, see 8 Keys to Compliance for Medical Science Liaisons - Part I (2/19/2007).

A company’s MSL team is the front line of the tension between scientific discussion and exchange and “off-label” promotion and other FDA and OIG rules and regulations. The following keys to compliance will help guide a MSL team to prevent claims that it has slipped into the prohibited territory of off-label promotion or breached other rules and regulations.

5) Create Guidelines Applicable to Information Exchange Regarding Unapproved Drugs

Healthcare professionals frequently request information from MSLs on the use of unapproved drugs. Companies should consider establishing structured guidelines and SOPs applicable to information a MSL may give regarding a company’s “pipeline.” FDA regulations provide that:

A sponsor or investigator, or any person acting on behalf of a sponsor or investigator, shall not represent in a promotional context that an investigational new drug is safe or effective for the purposes for which it is under investigation or otherwise promote the drug.

21 CFR § 312.7.

As with all other communications, a company should consider advising MSLs to use caution when discussing pipelines to avoid crossing the line into “promotional” activity. It should also provide MSLs with all available information regarding the pipeline, both positive and negative. It is important that MSLs are aware of the promotional restrictions surrounding unapproved drugs.

6) Review Interactions Between Sales Force and MSLs

MSLs should not be viewed or characterized as a tool for the sales force to use in promoting a product. Life science companies should consider establishing SOPs both for the sales force and for MSLs with guidance as to how the MSL and the sales force will interact. For example, SOPs can establish the process by which a member of the sales force may request an MSL visit for a customer. The process could range from an informal call to the MSL assigned to the region or a more formal request system operated by the company’s Medical Affairs department. There is no firm regulatory guidance on these interactions but having rules in place will help to evidence the company’s intent to use MSLs for proper purposes.

7) Create Guidance for Interactions between MSLs and IIT Programs

MSLs’ regular interactions with Key Opinion Leaders (“KOLs,” i.e., physican leaders in a specific practice area), naturally lend to their involvement with the company’s “Investigator Initiated,” “Investigator Sponsored” or “Grant-in-Aid” clinical trial programs. In managing interactions related to these trials, it is important for the MSL to avoid “seeding” trial ideas with KOLs. When the company funding the trial seeds the trial protocol through the MSL, the company risks becoming the de facto sponsor of the trial. Similarly, MSL teams should not encourage investigators to conduct excessive or redundant trials. The OIG may interpret excessive or redundant trials that provide compensation to the investigator as provision by the company of an illegal kickback to the investigator.

8) Avoid Involvement of MSLs in Promotional Context

Companies should consider advising MSLs to avoid involvement in promotional contexts, thereby further separating MSLs from the sales force. For example, MSLs may be discouraged from joining sales force personnel at promotional dinners. Similarly, MSLs should probably also be discouraged from joining the sales force on sales calls. To the extent MSLs are included in either of these situations, MSLs should consider themselves subject to the same promotional rules and regulations as the sales force. Thus, all statements made by an MSL in these promotional contexts should conform to FDA labeling requirements.

Life science companies may benefit by operating under a company-wide corporate compliance plan that incorporates specific guidelines or SOPs for the activities of MSLs. The guidance discussed herein, which of course is not legal advice, is but a starting point for any pharmaceutical or medical device company seeking to build a more compliant MSL team. If you would like additional information or desire assistance in improving your company’s MSL compliance, please contact us.

If you would like to receive our legal news updates by e-mail, please use our online sign-up form.

McGuireWoods news is intended to provide information of general interest to the public and is not intended to offer legal advice about specific situations or problems. McGuireWoods does not intend to create an attorney-client relationship by offering this information, and anyone's review of the information shall not be deemed to create such a relationship. You should consult a lawyer if you have a legal matter requiring attention.

MORE INFORMATION