Drugmaker Cephalon has agreed to pay $444 million to bring state and federal investigations of its sales and marketing practices to a close. As part of its settlement, Cephalon has agreed to plead guilty to promoting off label use of its painkiller Actiq--which was widely used for purposes outside of its original FDA approval--as well as narcolepsy pill Provigil and epilepsy treatment Gabitril. Cephalon has admitted that it had been marketing Actiq, a highly addictive narcotic lollipop produced to treat certain cancer patients, for off-label uses including migraines, sickle-cell pain crises and injuries.
All of this is important in and of itself, but the following is ground-breaking. In addition to these concessions, Cephalon has become the first pharmaceutical company to be required to publicly disclose its payments to physicians under a corporate integrity agreement with HHS. This is a really significant development, given that pretty much every other drug and devicemaker disclosing such information is doing so voluntarily.
Under the terms of the agreement, which lasts five years, by early 2010 the company must post on its website a searchable database of all physicians who acted as speakers, trained as speakers or consulted for the company during 2009. Next, during the first quarter of 2011, Cephalon will have to disclose, in ten-thousand-dollar increments, the names of doctors who received any payments from the company during the previous calendar year.
To learn more about the agreement:
- read this Wall Street Journal blog item
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