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James Czaban and John Kamp Discuss 2016 Issues in Pharmaceutical Law
James Czaban, chair of Wiley Rein LLP’s Food & Drug Law Practice and a partner in the firm’s Health Care Practice, and John Kamp, consulting counsel in the Food & Drug Law Practice, were quoted in a Bloomberg BNA article, discussing key concerns for the pharmaceutical and medical device industries in 2016. Among the key concerns were: reauthorization of FDA’s User Fee programs, drug pricing, the ongoing implementation of the Food and Drug Administration (FDA) approval pathway for biosimilars, and the continuing evolution of what drug companies can say about the off-label uses of their products.
Mr. Czaban weighed in on drug pricing, explaining that “the cost of manufacturing even an old generic drug in full compliance with FDA regulations is very expensive. If companies can’t price their drugs according to market demand, it’s going to lead to more and more drug shortages.”
According to the article, the “apparent collision between the FDA’s policy of restricting what drug manufacturers can tell health-care professionals about the off-label unapproved uses of their products and the First Amendment” will continue to be an issue in 2016. “I think the FDA’s going to bite the bullet on off-label issues and issue guidance,” said Mr. Kamp. “I think the FDA’s Chief Counsel’s office ‘gets’ it and the staff at CDER ‘gets’ it and they will do something,” he said.
“I’m most optimistic that they will do something on FDAMA [the Food and Drug Administration Modernization Act] Section 114 so there can be more discussions with payers and more substantive discussions,” Mr. Kamp said. “I’m hoping for a clean definition of the parameters of scientific exchange. I’d like to see them begin to discuss some additional off-label information, including information about post-clinical marketing in additional to clinical trials to come under the ambit of ‘truthful and non-misleading speech,” Mr. Kamp said.
“I think we’ll see more small companies with a lot at stake in their off-label communications challenge the FDA in court or at FDA on some of their restrictions,” Mr. Kamp added. “Mr. Czaban also chimed in saying, if the FDA doesn’t change what it’s doing, that will invite more litigation. But, he said, “the off-label issue is going to come to a head eventually.”
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