Payers “play such a gatekeeping role with respect to patients,” Kellie Combs, an attorney for Ropes & Gray, said during her testimony at the FDA’s public hearing on off-label communications. Photo credit: Anthony Albright/Creative Commons
Drugmakers told the FDA that allowing them to share off-label information with payers would be a critical first step in redefining off-label regulations.
The FDA held a two-day public hearing this week to gather information about off-label communications, after a series of lawsuits were decided in favor of the pharmaceutical industry.
At the hearing, industry stakeholders agreed with concerns over supplying information not vetted by the FDA to consumers, who may not understand the limitations of the data, and doctors, who may not have the time in their busy days to determine what information is misleading. This leaves payers as a likely starting point for sharing off-label information.
Payers “play such a gatekeeping role with respect to patients,” said Kellie Combs, an attorney for Ropes & Gray, who testified at the hearing on behalf of the Medical Information Working Group. “There’s a real interest in getting information to payers as soon as possible.”
As prescribing decisions are increasingly made by health systems and formulary committees — rather than physicians — allowing drugmakers to communicate with payers about data outside of the product’s label is critical, and payers’ sophisticated understanding of clinical data makes them low-hanging fruit, said Michael Labson, a partner at law firm Covington & Burling, and a representative of PhRMA.
In addition, certain types of data, like demonstrating a drug’s use in subpopulations and sharing pharmacoeconomic data, are examples of information that do not meet the FDA’s criteria but are still valuable to payers, said Dr. Sandra Milligan, SVP of global regulatory affairs and clinical safety at Merck. “Truthful, competent and reliable evidence should be a part of the dialogue with healthcare decision makers,” she added.
FDA officials asked a number of questions about what a regulatory framework for allowing off-label communications to payers would look like, after pharmaceutical executives brought up the need to speak with payers ahead of a drug’s FDA approval and also about data that is not included on a drug’s approved label.
Coleen Klasmeier, a partner at Sidley Austin, who also represents the Medical Information Working Group, argued that there would be a benefit to payers if drugmakers were allowed to share off-label information with them. She said the lack of current regulatory guidelines on this issue “undermines the ability for payers to receive high quality information” and that the “FDA has not addressed payers communications in a meaningful way.”
The agency will now consider whether to issue new guidance. FDA spokesperson Sarah Peddicord said in an email that the FDA insteads “to provide new guidance as needed after the meeting.”