REGULATORY FIX NEEDED FOR OFF-LABEL ENFORCEMENT

Law enforcement currently takes too prominent of a role in setting off-label enforcement policy, necessitating regulations to establish more consistent policy, an industry attorney said.

Currently, off-label promotion standards differ greatly based on which U.S. attorney is involved, making it difficult for companies to know what's expected of them, William Sarraille of Sidley Austin said during a Sept. 18 advertising and marketing conference sponsored by the Food and Drug Law Institute. Prosecutors seem to be taking a greater role in setting standards, essentially usurping agencies such as the FDA and the Centers for Medicare & Medicaid Services. This situation results in a "potential for uneven enforcement."

The solution is for the federal government to issue regulations making clear which off-label promotions are acceptable, he added. But while the agencies are discussing such federal standards, their effort is not keeping pace with law enforcement's increasing role, he said. "Law enforcement is increasingly driving the bus."

But Eugene Thirolf, director of the Justice Department's Office of Consumer Litigation, disagrees that prosecutors are attempting to take control of this issue from agencies. U.S. attorneys work alongside the FDA and the CMS in deciding whether to pursue a case, he said. "In today's government, you can't have one person off doing their own thing." Prosecutors are simply following current statutes and taking the cases referred to them, he added.