title: Regulation of smoking cessation drugs by the Food and Drug Administration.
abstract: There are about 50 million active cigarette smokers in the United States, and cigarette smoking accounts for almost 500,000 deaths each year. The World Health Organization (WHO) places the global total of such deaths at 5 million people annually. In the United States, this high-level of cigarette smoking occurs despite the fact that 70 percent of Americans who smoke report that they want to quit the habit. As a direct consequence of these statistics, several smoking cessation aids, some as the result of the discovery and development of new molecular entities, have been developed both domestically and abroad. While the timely development and commercialization of new molecular entities serves a vital public interest, so too do assurances of their safety and efficacy. This article proposes an integrated approach early in the clinical development of a new molecular entity to the design of premarket approval clinical studies, postmarket approval clinical studies, and Risk Evaluation and Mitigation Strategies (REMS), as a means of balancing these two important policy objectives.
authors.forename: Christopher
authors.initials: C
authors.lastname: Richins
mesh_terms: D001552:Benzazepines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D017277:Drug Approval; D004347:Drug Interactions; D033161:Government Regulation; D006801:Humans; D001523:Mental Disorders / Q000139:chemically induced / Q000188:drug therapy* / Q000523:psychology; D018722:Nicotinic Agonists / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011358:Product Surveillance, Postmarketing; D011619:Psychotropic Drugs / Q000009:adverse effects* / Q000627:therapeutic use; D011810:Quinoxalines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D012907:Smoking / Q000188:drug therapy; D016540:Smoking Cessation / Q000331:legislation & jurisprudence* / Q000523:psychology; D014481:United States; D014486:United States Food and Drug Administration; D000068580:Varenicline
chemical_list: D001552:Benzazepines; D018722:Nicotinic Agonists; D011619:Psychotropic Drugs; D011810:Quinoxalines; D000068580:Varenicline