For several decades, policymakers, government and health insurers have worked diligently to persuade American consumers that the financial benefits of generic pharmaceuticals — which now account for more than 70 percent of all drugs dispensed — come with no more risk than the name brands. That remains true of health risks, but legal risks just went way up. Two patients prescribed the same drug who suffer the same harm, about which there was no prior warning, could now encounter very different legal consequences if one’s prescriptions were filled with the name-brand drug while the other received a generic equivalent. Attorneys will be stuck explaining divergent legal paths, and possibly very different outcomes, to these patients after the U.S. Supreme Court’s recent decision in Pliva v. Mensing, 11 C.D.O.S. 7694.
Prescription drugs are regulated by the federal Food and Drug Administration. The first company to seek approval — the “pioneer” or name-brand manufacturer — must undertake a long and expensive process of testing to demonstrate the drug’s safety and effectiveness. Almost without exception, these drugs are patented. In 1984, Congress adopted the Hatch-Waxman amendments to enhance the patent rights of pioneer drug manufacturers, to compensate for regulatory approval delays, and to enable generic manufacturers to get approval to sell “copycat” versions of approved drugs after patent expiration without duplicating safety and effectiveness studies. The generic maker must demonstrate that its product has the same active ingredients as the name-brand drug, with the same route of administration, dosage form and strength, and that it is “bioequivalent.” With some exceptions, it must also bear the same labeling (21 U.S.C. §355(j)).
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