Managed Care - March 2008 - (Page 24) The Epilepsy Battle in the War Between Brands and Generics Brand-name manufacturers and many neurologists see danger in generic substitution, but the FDA insists that the practice is safe the same strict standards required for innovator products. Bioequivalence is further defined by a drug’s ability to dissolve in approximately the same n the war between brand-name drug compaamount of time as the innovator product. Based on nies and generics manufacturers, each side is information provided by the manufacturer of the almost religious in its orthodoxy and intrangeneric, the FDA determines how much of the acsigence. tive ingredient enters the bloodstream, how fast it The ground they fight over is the patient. On one does so, and how long it takes to leave the body — side are the large pharmaceutical companies, periwhat is known as bioavailability. odically joined by the disease-specific foundations “The important issue is absorption rates,” says they help fund. On the other side are public and priHarvard neurologist Steven Schachter, MD. “That vate payers trying to keep drug costs down. is the gist of the issue for clinicians, sociCaught in the middle are the Food and eties, and foundations. There are repeated reDrug Administration, Medicare, Medicaid, ports that there is a difference among the pharmacists and state legislatures. At stake generic substitutions for many drugs in ceris billions of dollars in drug costs. Trying to tain classes, such as epilepsy drugs.” make sense of it, let alone trying to deterThe National Kidney Foundation has remine the truth, is exasperating. peatedly expressed concern that generic “Hope springs eternal with the brandbioequivalence is lacking for many imname manufacturers,” says John Rector, munosuppressants used by transplant and general counsel for the National Commucancer patients. These are said to have narnity Pharmacists Association. “They always row therapeutic ranges within very specific appear to find some way, some new way, to A breakthrough seizure can have se- dosing requirements. The American Heart battle the generics.” The current battle primarily is centered rious consequences, Association has expressed similar concerns about antiarrhythmic drugs used to manage on antiepilepsy drugs, but manufacturers of so if there is a way “to guarantee that tachyarrhythmia. immunosuppressants for transplant and each generic was The battle over antiepilepsy drugs (AEDs) cancer patients and arrhythmia drugs are identical, I would now occurring in state legislatures best exalso skirmishing. The fight is over the con- feel assured,” says Steven Schachter, emplifies the confusion and tension. The cept of bioequivalence. MD. Epilepsy Foundation is particularly vocal. For a generic to be approved by the FDA The foundation, a not-for-profit group supunder the rules governing abbreviated new ported in part by the drug industry, says switching drug applications, it must contain the same active to generics could cause life-threatening seizures. ingredients as the innovator drug, though inactive Most of the action is taking place in state legisingredients may vary. The generic formulation latures. The Epilepsy Foundation is proposing must be identical in strength, dosage form, and model legislation to the states about epilepsy drug route of administration, and must have the same generic substitution: use indications as the original marketed drug. It “A pharmacist may not interchange an must be bioequivalent to the innovator drug; meet antiepileptic drug or formulation of an antiepilepthe same batch requirements for identity, strength, tic drug, brand or generic, for the treatment of purity, and quality; and be manufactured under By Martin Sipkoff Contributing Editor I 24 MANAGED CARE / MARCH 2008
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