Prescription drug costs account for an increasingly large fraction of overall health care costs in the developed world. Given this and the increased scrutiny paid to the large profits reported by the pharmaceutical industry, it is not surprising that reducing drug costs, while simultaneously maintaining health care quality, is an important goal. Promotion of generic drug use is a key strategy in this effort.
Despite the individual and societal benefits associated with lowering drug costs, generic drugs are underused. This is occurring even in the face of compelling evidence from bioequivalence and randomized controlled trials supporting the equivalence of generic drug products1 and efforts from payers to move patients and prescribers toward generics (eg, tiered pharmacy benefits and prior authorization for less cost-effective agents). As Green et al2 point out, the adoption of generic statins to decrease coronary heart disease risk has been slow and disappointingly incomplete, given the equivalence (in terms of clinical efficacy and safety) of generic-available and brand-only statins.
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In their commentary on generic drug use (1), Alldredge and Kayser state that, “In 2011, fewer prescriptions for generic simvastatin were written than for [branded] Lipitor despite a significant cost differential and no apparent clinical differences in efficacy and safety”. That statement seems to be in conflict with the views of the FDA. On June 8, 2011, the FDA issued a safety warning concerning simvastatin (2), in which physicians were advised to discontinue the use of simvastatin 80 mg (except in patients who had already been taking it safely for over one year). In addition, FDA advised that the dose of simvastatin should not exceed 10 mg for patients taking diltiazem or verapamil, and that, when prescribed to patients taking amlodipine, the maximum dose of simvastatin should be 20 mg. These safety warnings were based on reports of serious myopathy-related adverse events caused by simvastatin 80 mg, or by lower doses of simvastatin when combined with widely-prescribed calcium-channel blockers. Clinicians now have a maximum safe simvastatin dose of 40 mg, which lowers LDL cholesterol levels by about 40%, while atorvastatin 80 mg reduces LDL by about 55% (3). To date, the FDA has not deemed it necessary to issue such stringent safety restrictions on the use of atorvastatin.
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