Lemons into Lemonade: How an off-label marketing fine can be good for business

von freakoutcrazy

by AltMentalities

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?