Healthcare Compliance Perspective:
Prescription drug off-label marketing potentially injures many people in addition to constituting fraud, waste and abuse. The FDA approves limitations on use based upon scientific assessment, and mandates that contraindications / limitations be communicated to all potential users. Healthcare providers must audit to ensure that prescription medications are used in accordance with federal approval, no more and no less.
Although Subsys was approved by the Food and Drug Administration (FDA) to treat excruciating cancer-related breakthrough pain, the complaint alleges that the drug maker recklessly marketed the drug for much wider use, covering a much broader set of patients.
Additionally, the company allegedly engaged in a pattern of deceptive and illegal conduct by downplaying the drug’s risks of addiction, bribing doctors to prescribe the drug, and lying to healthcare providers to skirt their authorization process. The Attorney General’s office is seeking penalties and disgorgement of all revenues accumulated during the period of misconduct-up to $75 million.
Ignoring the purpose of the drug to provide relief to cancer patients who were suffering from excruciating pain, the company allegedly ignored this limited approval and instead broadly targeted many types of providers and patients and represented that the drug was appropriate for flares of mild pain. It also downplayed Subsys’ risk of addictiveness. The company further directed its sales representatives to urge providers to prescribe Subsys in high doses, which were more expensive than lower doses. A 30-unit prescription of the lowest strength medicine costs approximately $700, while a prescription for the highest strength costs over $3500.
The complaint alleges that the company’s sales representatives called on medical offices employing providers who had been arrested for illegal opioid distribution.
The company allegedly formed a business unit devoted solely to securing prior authorization from health plans for as many patients as possible and trained its prior authorization staff to imply that patients had cancer pain, even when they did not. The company also paid certain providers between $3000 and $5000 to act as “speakers,” at sham promotional events and implored its sales staff to obtain a “return on investment” on those payments by increasing prescription numbers.
