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Abstract: The U.S. Supreme Court's 2011 decision in PUVA v. Mensing left consumers of generic drugs without a remedy for failure-to-warn claims. The Court held that FDA regulations made it impossible for a generic drug manufacturer unilaterally to enhance its warning label. Because of this impossibility, the Court held that the FDA regulations preempt state failure-to-warn claims. The FDA regulations do not, however, preempt brand name drug consumers' claims against brand name drug manufacturers. Accordingly, consumers stand in starkly different positions depending on whether they consumed a brand name or a generic drug. This Note argues that the FDA should amend its regulations to allow all manufacturers unilaterally to enhance their warning labels. This would allow both generic and brand name consumers to recover from the manufacturer that produced the inadequately-labeled drug that was consumed.
Introduction
Drug manufacturers spend billions of dollars every year researching and developing new drugs.1 To recoup the invested money, these companies aggressively market their brand name drugs to doctors and patients direcdy.2 New drugs typically enjoy a twenty-year patent, during which the patent holder has the exclusive right to manufacture and market their brand name drug.3 After the patent expires, however, competing manufacturers often create generic duplicates of the drugs and sell them at a much lower price.4 If a generic drug manufacturer can prove that its drug is effectively identical in substance and labeling to the brand name drug, then the U.S. Food and Drug Administration (FDA)-the sole regulatory body responsible for ensuring the safety and efficacy of pharmaceutical drugs on the market-will allow the generic manufacturer to forego the rigorous clinical testing required of the brand name drug.5
Largely due to generic substitution laws, generic drugs account for the vast majority of drugs consumed.6 Every state has some form of generic substitution law that allows (and in some instances requires) pharmacists to fill prescriptions with a cheaper generic drug unless the doctor specifically requests the brand name drug.7 As a result, even though many doctors prescribe the brand name drug with which they are familiar,8 approximately seventy-five percent of prescriptions are filled with generics.9
The FDA requires new drugs to undergo extensive clinical testing before they can be marketed.10 Nonetheless, plaintiffs sometimes bring claims that the labeling...