Blame the FDA for missing-in-action off-label guidelines? Nope, say two lawmakers. It's the HHS

Fred Upton
House Energy and Commerce Committee chairman Fred Upton

Drugmakers have faulted the FDA for dragging its feet on new off-label marketing guidelines. After all, pharma companies have racked up a series of decisions lending free speech protections to their drug promotions--and agency officials themselves have been promising to speak on the issue for almost two years.

Now, some U.S. lawmakers are weighing in--and they’re placing the blame on HHS Secretary Sylvia Burwell. The House Energy and Commerce Committee fired off a letter to Burwell last week, saying that her agency is holding up the FDA’s proposed guidelines.

“It has come to the committee’s attention that such inaction may be the result of disagreements between FDA and HHS leadership,” stated the letter, signed by committee chairman Fred Upton and subcommittee on health chair Joseph Pitts. “Specifically, despite being on FDA’s guidance agenda since 2014, it is our understanding that HHS has not allowed FDA to issue its completed draft guidance addressing the scope of permissible ‘scientific exchange.’”

Upton and Pitts are advocating for another approach to the off-label problem--a legislative one--and they appear to be trying to twist Burwell’s arm for help in “modernizing law to reflect the intersection of off-label use and 21st century medicine.” They attached a proposed bill to their letter.

It’s part of a political battle over the 21st Century Cures Act, which at one point included specific provisions governing discussion of off-label uses for drugs. It’s not part of the bill now; all that’s included, the letter notes, are some provisions for payer discussions and a requirement that the FDA issue the long-promised guidance within 18 months of the law’s passing--the very guidance, the letter says, “the agency already sent to HHS for clearance.” The White House came out against the payer language, saying that it would “undermine regulatory standards,” the letter notes.

It’s also part of the ongoing debate over off-label marketing. A series of court rulings and legal settlements began with the influential U.S. v. Caronia ruling in 2013, which baldly stated, "The government cannot prosecute pharmaceutical manufacturers … for speech promoting the lawful, off-label use of an FDA-approved drug."

The FDA declined to appeal that ruling to the Supreme Court, so there's been a feeling that the agency might soften its stance, and officials have suggested that they’d weigh a new approach.

"[T]he agency is taking these first amendment concerns very seriously," Elizabeth Dickinson, the FDA's chief counsel, promised back in 2014. "We are currently carefully evaluating our policies in light of court decisions on first amendment issues," Center for Drug Evaluation and Research chief Janet Woodcock also said at the time.

Since then, it has settled two free-speech-based lawsuits, filed by Pacira Pharmaceuticals and Amarin, in ways that cracked open the door to “truthful” discussion of unapproved uses, but without opening it all the way.

In February, a panel of experts from the Duke-Margolis Center for Health Policy proposed a raft of potential changes to off-label policy--everything from a revamped website to make guidelines more easily accessible to a third-party panel that would review new off-label promotional materials and score the evidence used for backup.

Of course the FDA’s own thinking at this point isn’t public--whether held up by HHS red tape or not. Until the guidelines see the light of day, or Congress itself takes action, drugmakers have to deal with the uncertain status quo.

- see the committee’s letter

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