FDA to Hold Hearing on Updating Pharmaceutical Industry Speech Regulation

The Food and Drug Administration on Wednesday announced in the Federal Register that the agency will hold a public hearing in November to gather input about how companies communicate about their products.

Specifically, the agency will focus on how companies discuss off-label uses of their products, the notice says. The FDA regulates how drug and device makers communicate about their products through approved labels, but many of those companies say there’s more information about their products worth sharing to help providers and others provide better care to patients.

The agency will hold the two-day hearing Nov. 9 and 10, and will be accepting comments on the topic until Jan. 9, 2017.

Among other things, the agency is asking about how more communication from companies about unapproved uses of their pharmaceuticals or medical devices could affect public health; how changes in the health care industry, such as payers and formulary committees have more say over prescriptions, drive the need for drug and device makers to produce more data about the effectiveness of their products; and what standards should apply to unapproved use communications to ensure safety of patients.

Jeff Francer, vice president of law at the Pharmaceutical Research and Manufacturers of America, a trade group representing pharmaceutical companies, praised announcement. The current regulations facing drugmakers don’t allow companies to share all the available information about safety and value of treatments for patients, he said.

“Given our increasingly data-driven, value-based health care system, we hope that FDA will act quickly to define new and clearer regulatory standards to permit responsible sharing of information and data about medicines with other parties in the health care system,” he said in a statement.

PhRMA and the Biotechnology Innovation Organization last month called for more communication with other players in the health care system. Insurers have also said that having more information about new drugs before they hit the market would be helpful in setting their rates each year.

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