A former sales representative for Insys Therapeutics, the maker of the fentanyl-based painkiller Subsys, pleaded guilty today to participating in a scheme in which doctors were bribed to increase off-label prescribing of the opioid drug.
Michelle Breitenbach, 38, of Middletown, pleaded guilty to a second-degree charge of conspiracy to commit commercial bribery in Middlesex County Superior Court. She admitted that as a New Jersey sales representative for Insys, she participated in a scheme in which doctors were paid kickbacks and bribes in the form of speaker fees for marketing and education events in exchange for prescribing Subsys off-label.
Doctors who participated in the “speakers bureau program” for Insys purportedly spoke at events to educate other doctors about Subsys, law enforcement officials said. In reality, law enforcement officials said the events involved free meals at expensive restaurants, and doctors were paid as speakers even if they did not speak, or if other doctors did not show up to listen. Breitenbach said that the management at Insys pressured sales representatives to promote the speakers bureau program as a means to drive increased sales of Subsys. She admitted that the payments made to the doctors as “speakers” were actually rewards for prescribing more Subys.
Last year, the New Jersey Attorney General’s Office filed suit against Insys and its founder, John Kapoor, accusing the company of endangering the public through an unlawful marketing campaign designed to exponentially increase sales of Subys by making fraudulent claims and offering incentives to health care providers to prescribe Subsys to a broad array of pain patients.
Subsys is a spray form of fentanyl that has FDA approval only for intense breakthrough pain related to end-stage cancer. While doctors have discretion to legally prescribe drugs for off-label use beyond what is approved by the FDA, drug companies are prohibited from promoting their drugs for off-label use in an untruthful or misleading way, and from influencing healthcare providers’ prescription decisions with payments or other benefits.
Breitenbach could face up to five years in prison. Her sentencing is scheduled for July 6.