Lowell Kabnick, New York University Vein Center, USA, has warned US phlebologists to seek professional advice regarding the legal issues surrounding foam sclerotherapy and the use of compounded agents.
Lowell Kabnick, New York University Vein Center, USA, has warned US phlebologists to seek professional advice regarding the legal issues surrounding foam sclerotherapy and the use of compounded agents.
The US regulatory authority, the Food and Drug Administration (FDA), has not yet approved any foamed sclerotherapeutic product.
Sotradecol is, Kabnick said, the only commonly used FDA-approved sclerosing agent currently available in the USA. Because it is commercially available, it should not be compounded.
The FDA has historically avoided legal action against pharmacies practicing traditional compounding, according to Kabnick, as long as the compounders follow regulations.
At this time, polidocanol is not a known drug in the eyes of the FDA, and compounding of polidocanol is illegal.
Creating foam from an FDA-approved drug is known to alter its biological behavior, and is therefore classified as compounding. Once you change the biological behavior of a specific drug, a new application to the FDA for a “foamed product” is required. After the application has been filed, the drug in its new form must undergo rigorous testing to garner approval and become legally available for use.
Use of compounded or “altered drugs” could make the physician liable for criminal charges and significant fines, as well as invalidation of malpractice insurance.
Kabnick added that it is considered fraudulent to bill Medicare while using an unapproved drug.
Kabnick said that his presentation did not serve as legal advice, and that practitioners should speak to an attorney, the state board of medical examiners, or at least to their malpractice insurance carrier for validation and substantiation.
Kabnick issued the warning at the “It’s all about veins: Advances in venous therapy” event which was hosted by the Arizona Heart Institute and preceded the International Congress on Endovascular Interventions in February, 2009.
Don’t miss Lowell Kabnick at the CX Venous Day (7 April 2009). Register Now!
