Off-Label Device Marketing Under Increasing Scrutiny
The marketing of products — particularly medical devices — for purposes for which they were not developed, tested or intended is coming under increased scrutiny by the FDA and Congress.
Increasing federal and state healthcare costs, spillover from off-label violations in the pharmaceutical arena and controversy surrounding the use of drug eluting stents (DESs) have focused attention on the use of language in device advertising to promote uses not intended for the target population. This also comes at a time when the Democratic-controlled Congress is champing at the bit to investigate medical marketing practices after 12 years of being out of power.
For example, in December 2006, the FDA’s Circulatory System Devices Panel Meeting found that a majority of DESs “are implanted in patients or vessels with characteristics different than those studied to support marketing approval.” The panel generally agreed that off-label use of DESs is associated with an increased risk of stent thrombosis, death and myocardial infarction as compared to on-label use.
Later, at a March 12 meeting on off-label promotion of biliary stents, it was noted that up to 90 percent of the market consists of sales to catheter labs where these stents are used in vascular procedures. The problem is that they’re indicated for propping open the ducts that carry digestive fluids in patients with end-stage pancreatic cancer. The FDA called in more than a dozen manufacturers and took them to task for promoting these stents at cardiovascular conferences and listing them in the cardiovascular sections of catalogs. The agency gave these companies three weeks to change these practices.
The FDA can’t legally regulate the practice of medicine, but it can regulate manufacturers and their marketing practices. If the agency sees that the majority of a product’s use is off-label, it may suspect that the manufacturer is using off-label promotional practices.
The Office of the Inspector General (OIG) generally addresses these concerns in the context of lawsuits brought by whistle-blowers — sales reps or members of the target audience — under the False Claims Act. Under the act, which applies to Medicaid reimbursement, each violation is subject to a fine of $5,000 to $11,000, and the violator is subject to triple damages. Whistle-blowers can receive 15 to 30 percent of the damages. Companies in violation are subject to exclusion from federal programs, which in itself can be a crippling punishment.
Increasingly, courts and regulators are signaling that they’re ready to bear down hard on off-label device marketing. Consider:
- Assistant U.S. Attorney James Sheehan from the Eastern District of Pennsylvania, who was recently nominated as New York State’s Medicaid Inspector General, has stated along with other state officials that his enforcement efforts will encompass off-label marketing of medical devices;
- In the Caputo case in 2006, the U.S. District Court for the Northern District of Illinois sentenced the compliance officer of medical device manufacturer AbTox to six years of imprisonment after he was convicted for inter alia off-label device manufacturing; and
- In late March, Rep. Henry Waxman, (D-Calif), chairman of the House Committee on Oversight and Government Reform, wrote to five companies — including two device manufacturers — requesting copies of all internal and external materials and plans related to marketing stents for potential off-label use.
Don’t look to existing guidelines for black and white rules on off-label marketing. Many of the guidelines focus on such issues as what constitutes improper remuneration between manufacturers and healthcare professionals. AdvaMed’s latest Code of Ethics on Interactions with Healthcare Professionals has no mention of off-label promotions, instead highlighting issues such as gifts and travel reimbursement. A March 2007 PricewaterhouseCoopers study found that “the appropriate use of data from postmarket studies without violating off-label promotion rules” was a gray area in the current code.
The OIG’s April 2003 voluntary guidance for pharmaceutical companies — which applies to device manufacturers as well — emphasizes anti-kickback provisions but is silent on off-label promotions.
In the absence of clear-cut guidance, some good rules of thumb include:
- Limit sales presentations and other marketing materials to approved indications for a device;
- Avoid discussing off-label uses in any marketing materials; and
- If there is a need to mention off-label use — for example, in reference to an ongoing clinical trial — make sure to state prominently that the product has NOT been approved for that indication.
It’s permissible to distribute journal articles that discuss off-label use in some circumstances, but be sure the information is from a credible, objective source, that the entire article is distributed, rather than excerpts, and that it contains a disclaimer that this use is not FDA-approved. The request for the article must be initiated by a healthcare professional, and the company should keep records of such requests and distributions.
The bottom line is that in the current environment, it is a much safer bet to simply avoid distributing such material. There are other ways for physicians to obtain clinical information that will not put your company (or even your person) at risk for prosecution. — Todd Clark
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