FDA's Warning Letter Appeals Process Challenged. In response to FDA's decision to pursue enforcement action against TMJ Implants while the company's appeal of a warning letter is pending, House representatives have sent a letter to FDA questioning the appropriateness of this practice and requesting information on similar cases over the past 10 years. The representatives view this policy as bypassing the appeals process and resulting in the unavailability of relief within the agency. Additional information is available at www.thegraysheet.com (a subscription service).

CMS Maintains Existing Carotid Stenting Coverage. Despite indications that the agency would expand coverage of carotid stents for use in high-risk, asymptomatic patients with blockage greater than or equal to 80%, CMS issued a decision maintaining its 2005 coverage policy for a limited subset of these patients based on a re-evaluation of the evidence. Additional information is available at www.thegraysheet.com (a subscription service).

FDA Panel Recommends Approval of Link STAR Ankle. The advisory panel voted 4-2 in favor of premarket approval for the Scandinavian Total Ankle Replacement System on April 24. The STAR Ankle system is intended for use as a non-cemented implant to replace a painful arthritic and/or severely deformed ankle due to rheumatoid arthritis, primary arthrosis, or posttraumatic arthrosis. Additional information is available at www.thegraysheet.com (a subscription service).

Medical Device Usability Standard Aims to Focus Industry on Human Factors. FDA has increasingly been focusing on the importance of incorporating human factors in device development to avoid use errors caused by poor usability of devices. A draft international standard, IEC 62366, Medical Devices - Application of Usabillity Engineering to Medical Devices, addresses these issues and provides considerable guidance to device firms on how to incorporate human factors in device development. The draft standard will be voted on in June and, assuming a favorably reception, released in October or November of this year. Additional information is available at www.thegraysheet.com (a subscription service).

FDA Grants HDE to ev3's Onyx HD 500. The device, a liquid embolic system to treat wide-necked brain aneurysms, is a more viscous version of the company's Onyx 18 and 34 products that were approved for the treatment of brain arteriovenous malformations. The humanitarian device exemption ("HDE"), allowing the company to treat up to 4,000 patients in the U.S. each year, was based on data from 200 patients suggesting treatment of patients with wide-necked brain aneurysms with embolic coils is less effective. Additional information is available at www.thegraysheet.com (a subscription service).

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Analysis: FDA and Off-Label Use of Biliary Stents

While the Food and Drug Administration (“FDA”) has the authority to regulate off-label promotion by industry, the ultimate decision on the use of medical devices is made by physicians who use them in their everyday practice.  This is certainly the case with biliary stents, which are routinely used in the peripheral vasculature rather than the location for which they have been cleared.  This has led to a situation where a considerable volume of biliary stent sales have been driven by off-label use, creating an uneasy situation where these products have become the standard of care for indications for which they have neither been cleared or approved.  It has also created issues for manufacturers who face constant demands from clinicians for information on the vascular use of biliary stents.

Recognizing the issues posed by these circumstances, FDA recently invited industry manufacturers of biliary stents to a closed door meeting.  The purpose of the meeting was to impress upon the medical device industry the challenges presented by off-label use of biliary stents and the agency’s concerns regarding industry’s support for such practices, even in the absence of direct violation of the off-label promotion provisions.  In particular, the high clinical demand for biliary stents for the treatment of femoral artery disease has led to an apparent rise in adverse events associated with such use.  In addition, the widespread off-label use is limiting the ability of biliary stent manufacturers who are legitimately seeking approval for vascular indications to enroll patients in clinical studies to gain approval for peripheral indications, as many patients and providers already see these products as standard of care.

FDA has signaled its intent to increase its attention to off-label promotional practices by closely reviewing the labeling for these devices, issuing more warning letters to firms violating off-label promotional activities, and increasing off-label enforcement actions.  Beyond these actions, however, the agency has few alternative avenues to influence off-label use of biliary stents.  Potential factors contributing to the present circumstances include the high bar FDA sets for gaining approval for additional indications and the inability to use data from off-label uses to support approval for new indications.  In light of continuing patient safety concerns and existing limitations on the use of off-label data, it may be time to consider options for aligning interests and incentives in the relationship between FDA and its authority to regulate off-label promotion and the important protection afforded physicians to use FDA-regulated products off-label under the practice of medicine doctrine.