LEGAL GROUP SUPPORTS FORMER INDUSTRY OFFICIAL IN CASE REGARDING OFF-LABEL USE

The Washington Legal Foundation (WLF) is supporting a former regulatory affairs official's appeal of a recent court ruling that he conspired to sell a device that had not been approved by the FDA. The group's action presents a challenge to the agency's policies restricting device firms from promoting off-label uses of their products.

Robert Riley, former vice president of regulatory affairs at the now-defunct firm AbTox, was convicted April 20, 2006, along with the firm's CEO, Ross Caputo, of wire and mail fraud, selling an adulterated or misbranded device and conspiracy to defraud the FDA.

The WLF argues that the U.S. Court of Appeals for the 7th Circuit should overturn Riley's conviction "to the extent that the government's case rested in part upon truthful speech about off-label uses, and thus violated the protection commercial speech receives under the First Amendment," James Beck, a partner at Philadelphia law firm Dechert and author of the WLF's brief, said.

"Our brief takes the position that there may well have been illegal devices and fraudulent statements, but that the FDA took a position that did not distinguish between truthful speech or untruthful speech," Beck said. The brief notes that -- unlike physicians, patients and federal or state governments -- manufacturers "are silenced" when it comes to freely discussing off-label uses of medical products.

Although the judge in the trial conceded that the defendants' statements regarding off-label uses were not misleading, "he held that prosecuting them for making those statements was constitutionally permissible because it directly advanced the government's interest in encouraging manufacturers to seek FDA-approval for known off-label uses," according to the WLF.

The result was that the appellants "may well have been convicted, in whole or in part, for engaging in protected commercial speech," the group said. (http://www.fdanews.com/ddl/34_5/)