Industry’s responsibility to communicate on and off-label information to patients will be targeted in upcoming guidance, Califf said during a fireside chat at BIO in San Francisco last week.
“This is a matter of great personal interest to me. People do not know how to use products in the ideal way,” he told the packed room.
“I’ve had a lot of experience working with industry in my past, I have great respect for industry, but in general as a professional I’ve not looked to industry to be the least biased source of information. So to the extent that industry has information, it’s definitely my goal to get it out there, I just want to make every effort to have it to go through channels which don’t have bias.”
Presently some information held by a company is not public but communicated privately to physicians and clinicians, he continued, calling for all information known about a drug or a medical advice to be made available either in the US Food and Drug Administration (FDA) label or via prescriber and patient information.
“If you have useful information from a human study, you have a commitment to make that knowledge public.”
Califf said the FDA would be issuing some guidelines “in the very near future” but was reticent to give more details.
Califf also spoke on the FDA’s role in regulating the growing use of social media in the industry, describing how this could be a game-changer for both the Agency and drug companies.
“In the past we would depend on patient advocates; we might have talked to half a dozen people who might represent a million people with a disease. But now with social media and with the broad use of the internet we can communicate directly with people.”
However, he acknowledged there may also be concerns surrounding surreptitious advertising of both commercial products and those in development.
“Whether some of these details will need to be changed, I think we’ll learn as we go along. If we slip back just a couple of years it would be unimaginable that we would have billions of people with personal devices that could communicate so no one anticipated in the rules exactly what that regulatory scheme should look like.”
His comments come two years after the Agency’s first attempt at drawing up guidance was lambasted by a number of Big Pharma firms.