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FDA's Califf speaks to patient engagement, off-label communications


By Michael Fitzhugh
Staff Writer

SAN FRANCISCO – With "the age of authoritarian medicine" fast giving way to an era of consumer-driven health care, patients are more often "involved from the beginning" in defining what happens at the FDA, Commissioner Robert Califf told attendees at the BIO International Convention. The latitude drugmakers have to do so remains fuzzier.

Whereas in the past, the agency often spoke to small groups of representative advocates for thousands of patients, now, he said, "we're entering this very exciting, explosive era" in which "with social media and broad use of the Internet, we can communicate directly." Califf said that not only is that a boon for the agency but "we really encourage industry to think that way. The best way to develop products in the future is likely going to be to involve a lot of people with diseases to have a handle on what their needs are, what their expectations are, and what their risk tolerance may be."

Whether industry has the legal standing to do that continues to be a bone of contention, especially in media such as Facebook and Twitter where substantial risk lurks around the topic of off-label communications. As far as communicating about product development front, companies should have the freedom they need already though, said Califf.

On the off-label communications front though, Califf seemed to suggest that if information was supportable and worth sharing, it should be on a drug's label. The clinical trials construct, or "human experimentation," as Califf called it, and its associated institutional review board, create a commitment to produce generalizable knowledge. "That, to me means that if you have useful information from a human subject, you have a commitment to make that knowledge public. Then I ask what information do companies have that's not public that they'd like to communicate properly to physicians and patients?" If there's useful information, "the one place you know that information is going to be is in the label or prescriber information," he said. Publicly available information not included on labels is trickier, he said. "We are working on it."