Amarin Ruling Makes Judges Regulators: Law Professor

Yale Law School professor Amy Kapczynski says that a federal court decision in a suit brought by Amarin against FDA over dissemination of off-label information on its Vascepa in effect replaces drug regulators with judges, whose expertise in science and medical research varies considerably, when off-label promotion is concerned. Writing in an opinion piece for the Archives of Internal Medicine, Kapczynski says that not only do judges lack the requisite training to effectively assess complex drug claims, but they lack access to the necessary data and the tools that regulators have to evaluate and shape that data.

If the decision stands, she writes, companies with a drug approved for one use will only have to produce enough evidence to convince a judge, not FDA, to market it for additional indications. To be effective, she adds, a company’s marketing must also influence the prescribing patterns of physicians. And although physicians are a more sophisticated audience, she says, they are not in a position to substitute for regulators.

Kapczynski cautions that if the decision is allowed to stand, it may put patients and the evidence base for medical practice at risk. She argues that FDA aims not to censor company speech but to foster development of accurate and reliable information and then to channel that information into settings where it can be rigorously evaluated.

She notes that the agency is currently in settlement negotiations with Amarin, possibly not wishing to take a chance with this case in a higher court. “At some point, however,” she says, “FDA will have to either take the underlying issue about off-label marketing up the chain to the Supreme Court itself or lose a key aspect of its regulatory authority by a thousand cuts. If and when FDA finally takes a stand, it will need the help of experts who can help judges understand our drug regulatory system and render vivid the acute dangers of deregulation where medicines are concerned.”