Instructions for use are as important as the device itself, said Robert Klepinski.
Tightly controlling product promotion processes is a smart way to avoid off-label conflicts with FDA. Considering the many different avenues for communication, manufacturers must be even more aware of what they say about a product—and where and how they say it. One solution is to establish a standard operating procedure (SOP) that provides a solid framework for advertising methods, attendees at a conference in March learned.
“Advertising and promotion are part of the product,” said Robert Klepinski, an attorney at Fredrickson & Byron P.A. (Minneapolis). “You're not selling hardware; you're selling therapy to help people. The instructions for use are as important as the hardware itself.” Klepinski, along with other industry experts, discussed the risks of off-label promotion at the Medical Device Compliance and Regulatory Congress held at Harvard University (Cambridge, MA).
The instructions for a product's intended use are considered labeling. However, labeling isn't limited to the product and its packaging. Virtually any information that comes with a product is considered labeling—even a chart in an operating room that demonstrates how to use a device, said Judith O'Grady. She is the senior vice president of regulatory affairs, quality assurance, and clinical affairs at Integra LifeSciences Corp. (Plainsboro, NJ). Aside from information on the product and its packaging, labeling includes the following:
• Instructions for use and the device manual.
• Company Web sites.
• Press releases and video releases.
• Posters and other information displayed at professional meetings.
• Letters to physicians discussing product claims.
• Direct-to-consumer advertising.
Although companies want to keep patients aware of the latest product uses, approved or not, it can be a challenge to balance this desire with FDA's job of protecting patients. Companies can maintain this balance with an SOP that encompasses methods for the following:
• Product labeling.
• Written processes for developing promotional materials and for determining how information is reviewed and distributed.
• Periodic employee training.
The first step is to build procedures for promotional materials into the quality process early. Klepinski recommended that manufacturers begin with a claim chart when they start product planning and update it as product testing either verifies or disproves any claims. An SOP should include a written process that sets standards for promotional materials and designates the appropriate people to sign off on them. Before distribution, all materials must be reviewed by a medical director and product managers as well as company departments such as legal, regulatory, and clinical.
Even press releases can fall victim to off-label claims and, therefore, must be reviewed. A press release is a tool to inform an audience of what's coming, said Klepinski. The problem, he said, is that some companies turn the same releases into distributed advertisements. Everyone in the company needs to know the purpose of press releases and what can and can't be done with them. The same is true for the dissemination of articles that discuss an off-label use. The FDA Modernization Act of 1997 allows the distribution of journal articles and reference texts that discuss unapproved uses, but under strict requirements. These conditions include having a target audience of healthcare professionals (not consumers) and providing FDA with relevant clinical data before distributing the information.
Training employees early and periodically also prevents mistakes from controlling the company's promotion policy. Training should not be limited to the sales force, either. All departments—marketing, clinical, legal, regulatory, quality, and even senior management—should be involved, says O'Grady. One of the most important factors is that managers support company procedures and compliance initiatives.
“Organize yourself, and stay invisible,” advised Klepinski. Establishing an SOP and remaining consistent with promotional processes is an effective method that should prevent manufacturers from making off-label claims that could get themselves into serious trouble.