In a deal that could change the way some companies market their drugs, the Food and Drug Administration has agreed to allow a pharmaceutical company to promote a drug for a use that the agency has not approved, the company said on Tuesday.
The agency on Tuesday downplayed the implications of the deal. In a statement, it said that the settlement applied only to the Amarin case and that its position on whether companies have a constitutional right to provide truthful information about off-label uses had not changed.
Under the settlement, Amarin would have to submit proposed marketing materials to the agency, which could then object if it felt the information was untrue or misleading. If the two parties could not agree, a federal judge would sort it out.
Leaving such decisions to a judge, not the F.D.A., concerned Dr. Joshua M. Sharfstein, a former principal deputy commissioner at the F.D.A. who is now an associate dean at the Johns Hopkins Bloomberg School of Public Health.
“The courts are at the precipice of taking over a fundamental F.D.A. function of calling balls and strikes in the drug market about what’s truthful and not misleading,” Dr. Sharfstein said.
Alan Bennett, a lawyer who represents the Medical Information Working Group, a coalition of drug and device companies that want the F.D.A. to expand their ability to talk about their products, said he agreed that the F.D.A., not the judiciary, was best able to evaluate information about drugs.