Rx Adherence Claims For Ribasphere RibaPak Sent Packing
This article was originally published in The Pink Sheet Daily
FDA tells Kadmon Pharmaceuticals that it can’t promote convenience advantages, however factual, as clinical benefits without adequate and well-controlled studies.
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FDA advertising enforcement does not preference black-box drugs despite risk-based approach prioritizing products with significant risks; nor are drugs with small patient populations exempt from risk-based approach.
Pharmaceutical companies are spending more to help patients adhere to their therapeutic regimens – an almost universally recognized way to improve health outcomes and pharma’s bottom line. But an unclear legal and regulatory climate and poor understanding of the adherence problems it is trying to solve means industry isn’t trumpeting what could be one of its best health care value arguments.
FDA's Division of Drug Marketing, Advertising and Communications cites Kadmon for failing to include risk information and overstating efficacy in a "STATgram" promoting its hepatitis C treatment interferon alfacon-1.