Specialty Pharmacies Continue to Face Legal and Ethical Issues Employing Hemophilia Patients to Market Drug Products

Approximately 20,000 Americans suffer from hemophilia, a genetic disease which inhibits a patient’s blood clotting ability. Hemophilia is caused by genetic mutations in a patient, and is hereditary, meaning that the condition is often passed down from generation to generation. Hemophilia is treatable through a variety of specialty drug products which frequently cost over $100,000 a year, per patient, and can cost over $1 Million a year for some. The profitability of many of these hemophilia products, particularly expensive clotting factors, has created fierce competition amongst specialty pharmacies resulting in new and innovative techniques that are raising serious legal and ethical concerns.

In striving to better serve their patient populations, specialty pharmacies are subjecting themselves to enhanced legal and ethical scrutiny resulting from the development of innovative marketing techniques. One increasingly popular technique that some specialty pharmacies have implemented involves recruiting and employing their hemophilia patients to sell the pharmacy’s drug products to the patient’s family members and friends in the hemophilia community. Aside from the significant legal consequences that may follow from a pharmacy’s improper marketing relationships (e.g., violation of federal and state anti-kickback laws, etc.), a recent article published by the New York Times, entitled “Hemophilia Patient or Drug Seller? Dual Role Creates Ethical Quandry” (January 13, 2016), explores some of the ethical considerations that these pharmacies face when employing their hemophilia patients to market their products.

The article discusses the inherent conflict of interest an individual faces when they are both a hemophilia patient and a marketing representative for a specialty pharmacy dispensing hemophilia products. For instance, a patient serving as a representative may mislead family and friends suffering from hemophilia to purchase a more expensive or greater quantity of a drug product because of the anticipated compensation for the sale. Moreover, some specialty pharmacies have even gone so far as to recruit minors suffering from hemophilia for sales positions, which has raised concerns with parents and family members who believe their children are being taken advantage of by the industry.

Frier Levitt regularly counsels specialty pharmacies regarding the legal, regulatory and ethical considerations of employing marketers, including specialty pharmacies that choose to employ their patients to market hemophilia products. Amongst other considerations, Frier Levitt works with its specialty pharmacy clients to develop Standard Operating Procedures and otherwise counsel its clients to ensure compliance with all federal and state laws and regulations, as well as ethical responsibilities. Contact us to find out how we can assist your specialty pharmacy.

Tagged with: , , , , , , ,