“off-label” uses of the blockbuster drug Neurontin.
The May 2004 consumer protection settlement that served as the source of the grant funds was part of a $430 million, global federal and state settlement of the off-label marketing allegations against W-L. The consumer protection share of the global settlement was approximately $40 million, with 75 percent of the money earmarked for either the grant program or a corrective advertising program to provide balanced information to consumers and prescribers about Neurontin and similar drugs.
The grants announced [Aug. 31] represent the first phase of a multi-phase funding strategy developed by a “Special Committee” of state Attorneys General that includes Lockyer, Florida Attorney General Charles J. Crist, New York Attorney General Eliot Spitzer, North Carolina Attorney General Roy Cooper, Ohio Attorney General Jim Petro, Oregon Attorney General Hardy Myers, Texas Attorney General Greg Abbott and Vermont Attorney General William H. Sorrell.
Phase One of the strategy focuses on providing pharmaceutical marketing and drug information through educational campaigns that target prescribers and consumers. This phase will include several rounds of funding, with preference given to programs that are national in scope. The goal of the first phase is to better educate consumers and improve health care professionals‘ prescribing practices by providing information about the drug-approval process, drug marketing techniques, and sources of impartial and balanced information about drugs.
Proposals can be submitted by individual states, a group of states or other governmental entities. They also can be submitted by academic institutions, as well as nonprofit organizations with current section 501(c)(3) tax status and expertise in health-related or consumer protection issues. Nonprofit organizations must include in their applications written support from the Attorney General of any state in which the organization operates. Requests for Application may be found at www.publichealthtrust.org . The deadline for submitting Phase
One grant proposals is October 7, 2005.
Phase Two of the public education campaign will focus on providing information about seizure disorders and psychological conditions for which Neurontin has been prescribed. The details of the second phase will be developed as the program progresses.
The consumer protection investigation focused on alleged violations of state consumer protection laws by W-L in its promotion of Neurontin for various “off-label” indications. It is illegal for pharmaceutical manufacturers to promote off-label uses of their drugs, although doctors are permitted to prescribe drugs for such uses. Neurontin is a prescription medication approved by the U.S. Food and Drug Administration for treatment of epilepsy and post-herpetic neuralgia. Approximately 90 percent of Neurontin prescriptions, however, are for off-label purposes.