Seven large pharmas filed a citizen petition with FDA asking for guidance on communication about off-label uses for products.
The companies are looking to shed some light on a legal gray area that has long bedeviled them, and which has cost some of them hundreds of millions. At issue are unresolved questions over unsolicited requests for information, the use of third-party clinical guidelines and what companies can say to payors about off-label uses for their products.
“Unfortunately, the current state of regulatory guidance is not clear or comprehensive, or in some cases, even binding,” wrote lawyers representing Allergan, Eli Lilly & Co., J&J, Novartis, Novo Nordisk, Pfizer and Sanofi. “That lack of clarity places manufacturers at risk of criminal and civil sanctions if they cannot correctly guess where the government would draw a line [on information about off-label uses]. Industry should not have to refer to the terms of DOJ settlements or informal statements of FDA officials to learn what is expected of them prospectively.”
The petition asks that FDA clarify:
• How manufacturers can respond to unsolicited requests from healthcare professionals about off-label uses for their products, and what sort of response would be considered “non-promotional”
• How the agency defines “scientific exchange,” another ill-defined legal safe harbor. The manufacturers would like the term to cover statements that “make clear that a use or product is not FDA-approved or –cleared; make no claims that a use or product has been proven to be safe or effective; and be truthful land non-misleading when measured against available information on the use or product,” and to cover devices as well as drugs
• How companies can interact with formulary committees, payors and similar entities, particularly with healthcare economic info about off-label uses
• When pharmas can disseminate third-party clinical guidelines discussing off-label uses. The companies want the go-ahead to do so when clinical guidelines come from authoritative organizations, are unadulterated by the manufacturer, and include all guidelines on prospective rivals to the product in question.
"This petition addresses a number of issues that affect the entire pharmaceutical industry," said Alan Bennett of Ropes and Gray, one of the law firms that worked on the petition. "We think this is an important step in making the marketing rules more transparent. Enhanced transparency will be helpful to all stakeholders."
Unless the FDA steps in and referees these questions, the companies said, the public health will suffer as pharmas over- or under-communicate clinically relevant information according to their own interpretations. For those that err on the side of over-communication, of course, this guessing game will continue to prove costly.
“Because of the lack of clarity, HHS and the Inspectors General are making this law up along the way and they have picked the pocket of FDA,” said John Kamp, executive director of the Coalition for Healthcare Communication. “If companies know what the rules are, they'll play by the rules.”