Connecticut Atty. General George Jepsen said Monday (May 7) the state will receive approximately $6 million from settlements with Abbott Laboratories in relation to charges the pharmaceutical company marketed the prescription drug Depakote for uses not approved by the U.S. Food and Drug Administration (FDA).
Depakote is approved by the FDA for treatment of seizure disorders, “mania” associated with bipolar disorder and to prevent migraine headaches.
According to complaints, Abbott also marketed the drug for behavioral disturbances in dementia patients, anxiety, conduct disorders, obsessive-compulsive disorder, post-traumatic stress disorder, alcohol and drug withdrawal, attention deficit disorder, autism and other psychiatric conditions – uses the FDA has not deemed to be effective.
According to the allegations in the complaint, Abbott Laboratories promoted Depakote for unapproved uses by:
- making false and misleading statements about the safety, efficacy, dosing and cost-effectiveness of Depakote for some of these uses;
- improperly marketing the product for use in nursing homes;
- and by offering and paying illegal remuneration to health care professionals and long-term care pharmacy providers to encourage them to promote and/or prescribe Depakote.
Abbott Laboratories’ marketing for non-FDA approved uses allegedly resulted in false claims to Medicaid and other federal healthcare programs.
Jepsen said these settlements “will serve as a deterrent to other companies who seek to benefit unfairly from government healthcare programs.”
“Most importantly, they will help to protect consumers who were prescribed an expensive drug with little evidence the drug could help their condition,” Jepsen said.
In the settlements, Abbott has agreed to pay the involved states and the federal government $800 million in civil damages and penalties.
Connecticut’s share of Medicaid claims is more than $3.9 million.
Connecticut will also receive $499,000 for state-funded benefit programs administered by the state Department of Social services.
Social Services Commissioner Roderick L. Bremby said, “Our claims data indicated a significant and inappropriate impact on Medicaid expenditures, a factor that will now be mitigated by this major settlement.”
The company has also agreed to a $700 million criminal fine and forfeiture for violating the federal Food, Drug and Cosmetic Act.
Another $100 million settlement with 45 states and the District of Columbia, resolves civil consumer protection claims that the company engaged in unfair and deceptive practices by illegal off-label marketing of Depakote.
Connecticut’s share of the consumer protection settlement is more than $1.5 million, including $150,000 for the state Department of Consumer Protection’s Prescription Drug Monitoring Program.
Consumer Protection Commissioner William M. Rubenstein said, “The funding that the settlement provides for Connecticut’s Prescription Monitoring Program will directly benefit patient health by assisting pharmacists and physicians to better monitor potentially dangerous drug interactions and prescription errors.”
Abbott also agreed to enter into a corporate integrity agreement with the federal government.
For a period of five years, Abbott must also limit:
- the creation and use of responses to requests by physicians for non-promotional information about off-label uses of Depakote;
- dissemination of reprints of clinical studies relating to off-label uses of Depakote;
- and use of grants and continuing medical education.
It must also disclose payments to physicians and register and disclose clinical trials.
The healthcare fraud settlement was based on four qui tam cases, filed under federal and state false claim statutes that were consolidated and are pending in U.S. District Court in Virginia.
Assistant Atty. General Thomas Saadi handled the consumer protection settlement for the Attorney General with Assistant Atty. General Phillip Rosario, head of the Consumer Protection department.
Consumers can make inquiries of the Attorney General’s office by calling 860-808-5318 during office hours or sending email to firstname.lastname@example.org You can also follow the office on Facebook at Attorney General George Jepsen and on Twitter @AGJepsen
Posted May 9, 2012, based on a press release
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