title: The 21st Century Cures Act: pharmacoeconomic boon or bane?
abstract: Barriers to entry in healthcare markets constitute one of the overriding concerns of health economists. The recent enactment of the 21st Century Cures Act in the United States reduces statutory entry barriers to the discovery, development, testing, and licensing of drugs and medical devices. Drug and device makers also see the burdensome and time-consuming requirements of the Food and Drug Administration?s approval process as key barriers to lowering the costs of their products, considering it takes a decade of research amounting to $1 billion just to bring a single drug to the market. Along with novel opportunities for medical product innovation and faster treatment of diseases, the expedited approval process carries with it contentious challenges involving the safety, efficacy and value of drugs and devices. The ensuing trade-offs and unintended consequences of such a regulatory game-changer bring to the fore one of the most enduring debates between medicine and economics: Whether - or to what extent - cost and efficiency factors affect clinical inquiry into possible solutions to human illnesses. The practical and theoretical contributions of pharmacoeconomics should enlighten contemporary and future issues and discussions surrounding the implementation of this landmark legislation. After all, despite its undeniably good intent and far-reaching significance, no law can ever be perfect.
authors.affiliation: a Wilmington University , New Castle , DE , USA.
authors.forename: Roger Lee
authors.initials: RL
authors.lastname: Mendoza
mesh_terms: D035843:Biomedical Research / Q000191:economics / Q000331:legislation & jurisprudence; D017277:Drug Approval / Q000191:economics / Q000331:legislation & jurisprudence; D004345:Drug Industry / Q000191:economics* / Q000331:legislation & jurisprudence*; D017850:Economics, Pharmaceutical / Q000331:legislation & jurisprudence*; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence*
keywords: C7; I11; I18; K32; barriers to entry; clinical trials; drugs; economic efficiency; medical devices; pharmaceutical markets; regulatory