Latest cases involve epilepsy, hemophilia drugs promoted for “off-label” uses
OLYMPIA – Attorney General Rob McKenna today announced that Washington joined the federal government and other states in reaching agreements with two drug manufacturers accused of improperly marketing medications.
The combined proceeds in the settlements return about $500,000 to state health care programs and to the state’s general fund. The rest of the settlement funds – about another $500,000 – go to the federal government to cover its share of Medicaid contributions in Washington state.
The drug companies are accused of providing kickbacks to medical professionals in order to promote drugs for off-label uses. These illegal incentives routinely include honoraria, grants, dinners and paid advisory boards.
UCB, INC.
In a national settlement with UCB, Inc., government attorneys allege that from January 2003 through the end of March 2005, the drug manufacturer promoted the sale and use of Keppra for headaches, migraines, pain, bipolar, mood disorders and anxiety even though the drug is not approved by the Food and Drug Administration (FDA) for those conditions. Keppra was approved for symptoms related to epilepsy. Unapproved uses for drugs are not eligible for reimbursement by Medicaid.Washington’s share returns nearly $91,000 to the state’s Medicaid program and about $109,000 to the state’s general fund.
NOVO NORDISK, INC.
A settlement with pharmaceutical manufacturer Novo Nordisk Inc., involves NovoSeven, which is FDA-approved to treat bleeding disorders related to hemophilia and other specific conditions. Government attorneys say that between 2000 and 2008, Novo Nordisk knowingly promoted the drug to control severe bleeding in all trauma patients, including military personnel, which is outside of the drug’s approved use.Washington’s share of the settlement returns $146,000 to the state’s Medicaid program and $161,000 to the general fund. Remaining funds are returned to the federal government.
State portions of Medicaid settlements are based on how much was spent on the drug in each state during the time in question.
Last calendar year, the Medicaid Fraud Unit recovered nearly $25 million in settlements with drug companies.
Saturday, June 18, 2011
Attorney General McKenna unveils $1 million in drug company settlements
via atg.wa.gov
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1 comment:
The prohibition against drug company marketing of drugs for uses not approved by the FDA is reasonable and necessary.
However, I am disturbed by the statement that:
Unapproved uses for drugs are not eligible for reimbursement by Medicaid.
As a physician I will tell you that it would be impossible to practice medicine without using drugs for purposes that are not approved by the FDA. The lack of FDA approval for a new indication stems from the costs of obtaining such approval. In the case of a drug already on the market for one indication, drug companies will not incur such expense to obtain approval for a new indication. However, that does not mean that such off-label uses are not well supported by research published in the medical literature. That is true for Keppra.
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