1st Amendment Losses Draw FDA to ‘Truthful’ Speech: Samp
After recent First Amendment losses, FDA has moved away from its theory of using speech by companies as evidence they may be distributing a drug for an unapproved use, according to Washington Legal Foundation chief counsel Richard Samp. Speaking at an American University College of Law seminar (video link) on off-label marketing and First Amendment concern 3/31, Samp said that after the Caronia decision (see story) the “principal battleground that is being fought right now has much more to do with what is truthful speech.”
FDA typically has required two well-controlled studies to demonstrate evidence that can support truthfulness, Samp noted, but the recent Amarin settlement (see story) struck down the agency’s argument about what constitutes a legitimate study. He said the key to off-label promotion is determining what is truthful, and it’s the area that is going to be the most litigated in the years to come. “The difficulty in cases like Amarin is that they are very fact-intensive, and so it becomes difficult to take a decision like that and broaden it for application to other cases,” he told the seminar. “But certainly we are going to see more of these in the future.”
Samp argued that the big problem is not off-label promotion of drugs, but rather the “wild west area called dietary supplements.” Legislation adopted by Congress allows supplement marketers to promote products in an “under-controlled” environment.
Georgetown University Medical Center associate professor and PharmedOut director Adriane Fugh-Berman was very critical of industry’s off-label promotions and FDA’s enforcement efforts. “There is robust off-label promotion going on now and it is confusing doctors, and companies are lying about the evidence,” she said. Mitigating any legal power to fight this is the worst possible thing for public health, and will result in more drug-induced illness and death, she warned. “FDA is really naive about what constitutes promotion,” she said, complaining about industry-funded and -influenced marketing information that masquerades as continuing medical education.
Hyman Phelps & McNamara and former FDA attorney Ann Walsh said False Claims Act cases have diminished substantially. The resolutions and litigation have changed the conduct of industry such that whistleblowers are not bringing cases that are all over the waterfront, she said. “The types of claims are typically focused on identifying false or misleading types of conduct versus the truthful and misleading speech that we are talking about here,” Walsh told the seminar. “We will still see False Claims Act cases brought, and the questions will be focused on what is considered misleading.”
Public Citizen Litigation Group director Allison Zieve said FDA has shown an increasing unwillingness to stand up for its statutory authority. It settles cases because it is scared of losing. “We have a Supreme Court where, for many years, the majority has a broad view of 1st Amendment protections, and lower courts have internalized this by going overboard,” she said. “FDA is scared to push it because it is worried about losing all of their regulatory authority, and they keep giving away little pieces of it, which is dangerous and undercutting the authority they are trying to protect... I expect to see a loosening of patient protections and that will go on until we have a tragedy that will swing the pendulum back.”