JUSTICE DEPARTMENT TO MAINTAIN FOCUS ON OFF-LABEL RX FRAUD
Ferreting out off-label drug fraud remains a top priority at the Department of Justice (DOJ), especially in light of the government's aim to cut $10 billion from Medicaid and the new competitive pressures expected with next year's Medicare prescription drug benefit, says a top DOJ official.
Medicaid payments for improper off-label drug use, for example, could total hundreds of millions of dollars, said Jeffrey Bucholtz, a deputy assistant attorney general in the DOJ's Civil Division. Under the Federal Food, Drug, and Cosmetic Act, doctors may prescribe a drug for off-label uses, but firms are prohibited from marketing their products for these uses.
Determining what constitutes illegal off-label marketing occurs on a case-by-case basis, said Bucholtz, who recently told a Food and Drug Law Institute conference that there is "no easy formula for what practices will draw government scrutiny." However, there are activities that raise red flags at the DOJ, including paying doctors to attend meetings in expensive restaurants, sporting events or exotic locales to hear presentations about off-label uses; paying large fees to "thought leaders" to give speeches touting off-labels uses; directing sales representatives to market a drug to doctors who, because of their specialty, are very unlikely to ever prescribe the drug for the approved use; using medical liaisons, who are supposed to be impartial, but who are paid by the manufacturer; and making promotional claims that are not truthful, balanced or substantiated.
Cooperation, he added, is more than simply not obstructing the investigation or merely providing documents that have been compelled by subpoena. Examples of strong corporate cooperation include making witnesses available for interviews without the DOJ having to issue subpoenas.
In addition, firms are encouraged to take swift disciplinary actions in off-label abuse cases, such as replacing managers responsible for the illegal marketing and terminating employees who refuse to cooperate with the investigation.