Lemons into Lemonade: How an off-label marketing fine can be good for business 10/30/2012Posted by ALT in Pharmaceuticals.
Tags: bipolar, gabapentin, Lyrica, Neurontin, off-label marketing, Pfizer
2000: Sales of Pfizer’s Neurontin, a medication approved for the treatment of epilepsy, reach nearly $1 billion — a big surprise for a medication geared towards such a small, niche market.
2002: The media breaks the story of a lawsuit (Franklin v. Pfizer) charging that Pfizer illegally marketed Neurontin off-label as a treatment for individuals labeled as “bipolar.”
May, 2004: Pfizer pleads guilty to charges of marketing Neurontin off-label and pays $430 million in fines. By some estimates, around 90% of Neurontin sales were for off-label purposes.
(3 months later)
August, 2004: Generic form of Neurontin (gabapentin) becomes available.
(4 months later)
December, 2004: The FDA approves Pfizer’s Lyrica, a new drug for epilepsy similar to Neurontin. The company begins to aggressively market this new, patented (ie, expensive) drug.
(Can you see where this is going?)
2009: Pfizer settles another off-label marketing suit for $2.3 billion involving Lyrica and several other drugs.
2011: Sales of Lyrica reach $3.1 billion, 2 years before patent is set to expire.
Neurontin was coming off patent anyway and the lawsuits simply accelerated the desired shift from off-label Neurontin use to off-label Lyrica use.
-Dr. Randall S. Stafford, who studies drug marketing
2012: A new study documents an increase in spending on epilepsy drugs prescribed off-label for individuals labeled as “bipolar.” The authors suggest that off-label marketing lawsuits merely caused a substitution of new epilepsy medications for old ones in the off-label marketing/prescribing equation.
In recent years there have been several large lawsuits setting out to punish pharmaceutical companies for illegal off-label promotion…[I] suspected that it might be possible that there could be unintended consequences of that. The unintended consequences are substitution of similarly unsubstantiated [and patented] products and an increase in spending [on off-label prescriptions] overall.
-Meredith Chance, pharmaceutical policy researcher and co-author of a new study: “Intended and Unintended Consequences of the Gabapentin Off-Label Marketing Lawsuit Among Patients With Bipolar Disorder”
The end was near for Neurontin, and Lyrica was waiting in the wings. Was taking the hit for off-label marketing in 2004 all part of a plan to boost sales for forthcoming Lyrica, now the star performer in the Pfizer portfolio?