12 for ’12 #12: Stopping Prescription Drug Abuse
January 9, 2012 – State Senator Brian Kelsey (R-Germantown) today introduced legislation that reduces TennCare costs by ensuring that psychotropic drugs are prescribed only for approved uses. A psychotropic drug is one that is designed, marketed, or approved by the FDA for the purpose of affecting the “mood or mental state” of the patient. Senate Bill 2178 directs TennCare to reimburse health care providers only for FDA-approved uses of psychotropic drugs.
The legislation is the last in a series of announcements by Kelsey in his “12 for ’12” initiative for the next legislative session, which is set to reconvene at noon tomorrow.
“This bill will save our state millions of dollars and improve health outcomes. Our children, parents, and grandparents are being given strong psychoactive medications that have not been clinically reviewed for the prescribed use.”
Under the Food, Drug and Cosmetic Act, a company must specify the intended uses of a product in its new drug application to the Federal Drug Administration. Before approving a drug, the FDA must determine that the drug is safe and effective for the use proposed by the company. Once approved, the drug may not be marketed or promoted to patients or doctors for any unapproved or “off-label” uses.
Drug companies across the nation have paid billions of dollars in settlements arising from the off-label promotion of psychiatric drugs. In 2009, the Tennessee Attorney General recovered $11.3 million in restitution from Eli Lilly and Company for the improper marketing of its anti-psychotic drug Zyprexa. Lilly was accused of promoting Zyprexa for unapproved conditions such as depression, anxiety, nausea, and even gambling addiction. In 2010, the U.S. Department of Justice obtained a $520 million settlement from the company, AstraZeneca, for the off-label marketing of its anti-psychotic drug, Seroquel, which was approved for the treatment of schizophrenia and bipolar disorder. AstraZeneca had been accused of promoting the off-label use of the drug for the treatment of conditions ranging from “anger management” to attention deficit and hyperactivity disorder.
Many advocates believe that children are being unnecessarily prescribed these drugs in response to minor behavioral problems. According to a Vanderbilt University study, the proportion of TennCare children who became new users of antipsychotics nearly doubled from 1996 to 2001, with a substantial increase in the use of antipsychotics for attention-deficit/hyperactivity disorder, conduct disorder, and affective disorders. Meanwhile, prescription of these drugs for non-FDA-approved indications now accounts for most treatment and has been growing faster than treatment for FDA-approved indications. The alarming rates at which children are being prescribed these drugs are even higher for those in the foster care system. According to a 2010 study, children in 13 States who are in foster care and enrolled in Medicaid were prescribed antipsychotic medications at nearly nine times the rate of children enrolled in Medicaid who were not in foster care.
“This bill will ensure that our TennCare funds are spent for the appropriate medical purposes. Denying payment for the off-label use of these powerful drugs will help shield our most vulnerable patients from a potentially unsafe and ineffective course of treatment,” concluded Kelsey.