FDA to Review Off-Label Use of Biliary Stents

Showing an ever-growing presence in the post-market medical device arena, it now appears that the FDA is going after biliary stent manufacturers to review “off-label” use of these devices to prop open larger blood vessels.

Tiny bile-duct scaffolds, known formally as biliary stents, are supposed to prop open the tubes that carry digestive fluids to the intestines, as opposed to blood-pumping arteries, which are the province of stents approved for vascular uses, including drug-coated coronary stents used near the heart.

But since biliary stents are available in much larger sizes than their vascular cousins, doctors commonly use them to prop open large arteries, such as those leading to the legs and kidneys. "Our go-to stent for disease in the legs are biliary stents," said Dr. Gary L. Schaer, the director of the cardiac-catheterization laboratory at Rush Hospital in Chicago. A September 2006 article by an FDA scientist also concluded that "virtually all" kidney-artery operations used stents not approved for that purpose.

Some industry sources estimate that as much as 90% of biliary stents are sold to catheterization laboratories and used off-label in arteries. On-label sales of biliary stents amounted to about $38 million last year, according to Millennium Research Group. Those numbers don't include off-label use in arteries.

Government intervention for patient safety is critically important, especially when the use of drugs or devices shows significant harm to patients. But government intervention in health care also may threaten the very way medicine is practiced today.

In the case of biliary stents, doctors devised a creative solution to a difficult clinical conundrum (resolving blockage in a large artery when no FDA-approved tool exists) that has helped many patients avoid significant complications from major surgery. When these doctors compared the results of a minimally-invasive approach to the difficulties their patients had with major open surgical procedures like infection/wound healing, etc, they were hooked. The biliary stent companies responded to the demand in kind.

The situation is analogous to the early days of catheter ablation. As an electrophysiologist, I can vividly recall the conundrum the FDA was placed in when catheter ablation burst onto the scene of cardiac arrhythmia management. Doctors recognized then that significant risks existed with open heart surgery for surgical arrhythmia management and felt (correctly) that the morbidity and mortality of off-label catheters for catheter ablation was safer for their patients.

But now, if the FDA restricts the sale of these stents to patients when no properly-labeled alternative exists on the market, will physicians be forced to change their practice and take a giant leap backward in patient care management in the interest of proper FDA labeling practices?

And why stop with stent manufacturers? Is the FDA going to extend their reach still further? What about off-label drug use?

Physicians have a long history of off-label drug use. Take the drug amiodarone, for instance. Amiodarone is the most commonly prescribed (and effective) antiarrhythmic medication prescribed for atrial fibrillation, an irregular heart rhythm of the upper heart chambers, but is not approved for this indication. Could the FDA force manufacturers to go back to the drawing board before sales for such drugs are permitted for "off-label" indications?

This would set an ominous new precedent for physicians and their patients. It would also set an ominous new precedent for the medical device and pharmaceutical industry. Worse still, it would set a new precedent for the legal industry to proceed to litigate every off-label complication that occurs to a patient - be it drug or device.

-Wes