May 31, 2016 – Although the U.S. Supreme Court and other courts consistently are deciding cases in favor of First Amendment protections for commercial speech – including speech about off-label uses – the movement toward a “truthful and non-misleading” standard has not moved the needle on this issue at the FDA, according to Alan Bennett, senior counsel, Ropes & Gray.
Case law regarding promotional communication has been building over the past few years, with courts beginning to conclude that all pharmaceutical speech is promotional and that there really is not a distinction between scientific exchange and promotion, Bennett explained at a recent Coalition for Healthcare Communication Rising Leaders Conference held May 11 in Washington, D.C.
FDA inaction is troubling
The courts seem to agree that “promotion – even off-label promotion – is permissible as long as it is truthful and not misleading,” Bennett said, “But the FDA has not explicitly recognized yet that these cases make any difference. They have tried to explain [them] away.”
When asked by APCO Worldwide’s Wayne Pines, who moderated the discussion, whether the risk of off-label promotion has been lowered by these court decisions, Bennett said that companies still have to be very careful because he believes that the FDA is paying close attention to this issue and could be looking for a test case where someone is hurt by a promoted off-label use.
“You don’t want to be that test case,” he noted. He clarified that although promotional speech itself is protected, if it is accompanied by some other unlawful act and “you are talking about that illegal act, the government can use that speech as evidence in those cases.”
However, Bennett also told Coalition members that if pharmaceutical companies “have adequate, well-controlled studies that you are very comfortable with and you think will withstand scrutiny, and you want to promote those studies, you should go discuss it with the FDA.” He added that companies should not fear retaliation by the FDA if the agency does not agree with them. “If you go to the agency with a good idea and have an adult conversation, there is no legal risk to trying,” he advised. “The FDA has adversarial conversations all the time and don’t take it personally.”
Congress questions FDA’s authority
Following up on concerns about the FDA’s inaction on updating its off-label use communication policy, House Energy & Commerce Committee Chairman Fred Upton (R-Mich.) and Health Subcommittee Chairman Joseph Pitts (R-Pa.), wrote a letter to the Department of Health & Human Services May 26 which stated that “recent litigation has raised significant questions about FDA’s authority to restrict such communication.”
“As FDA’s authorizing committee, we are increasingly perplexed by the agency’s unwillingness or inability to publicly clarify its current thinking on these issues in a coherent manner,” the letter states. “If FDA continues to remain silent, settlement agreements will be the only means by which policy is formulated—and it will be in an ad hoc manner lacking any semblance of consistency and cohesiveness.”
The letter also suggests that the FDA’s inaction “may be the result of disagreements between FDA and HHS leadership,” and that “the committee is open to considering alternative approaches to address such an important issue.” However, bottom line, “Congress needs a willing partner that will engage seriously in modernizing law to reflect the intersection of off-label use and 21st century medicine.”
A need to improve drug development process
Kay Holcombe, senior vice president, Science Policy, at the Biotechnology Industry Organization (BIO), presented a legislative update as part of the Coalition panel. She said that the agency is meeting all of its targets for standard and priority reviews thanks to user fees. Accordingly, Congress’ current focus is on making the drug development process more efficient, as set forth in the 21st Century Cures Act. “It’s not about fixing the FDA, it’s about fixing the interaction between the FDA and the people who are developing drugs,” Holcombe said.
She explained that the Senate is currently working on its version of the 21st Century Cures Act, which already has been passed by the House, but noted that currently there are 19 separate bills in the Senate that must now come together in a bipartisan bill. Pines opined that he did not think a bill would be passed this session, and asked Holcombe what elements of the Cures legislation might end up being a part of upcoming Prescription Drug User Fee Act (PDUFA) reauthorization legislation. Holcombe stated that qualification and implementation of new drug development tools, patient-focused drug development and innovative clinical trial design were likely candidates.
Bennett added that payer communications is an area that is likely to undergo change in the near future. “FDA is working on the guidance and is fairly far along in the process,” he said. “It is the hardest area for the FDA to defend in the face of the First Amendment. Payers are sophisticated organizations, so I think it will work itself out in the next 18 months.”