title: How the US Food and Drug Administration can solve the prescription drug shortage problem.
abstract: Drug shortages are threatening care quality and cost-containment efforts. I describe the pharmaceutical marketplace changes that have caused the problem, and propose new policies to solve it, through changing incentives for producers and purchasers. I propose a grading scheme for the Food and Drug Administration when it inspects manufacturing facilities in the United States and abroad. The inspections' focus would change from closing unsafe plants to improving production process quality, reducing the likelihood that plants will be closed-the most frequent cause of drug shortages.
authors.affiliation: Department of Health Policy and Management, University of California Los Angeles Fielding School of Public Health, Los Angeles, CA 90095-1772, USA. sschweit@ucla.edu
authors.forename: Stuart O
authors.initials: SO
authors.lastname: Schweitzer
mesh_terms: D003363:Cost Control / Q000379:methods; D016527:Drug Costs / Q000639:trends; D004345:Drug Industry / Q000191:economics / Q000592:standards* / Q000639:trends; D016568:Drugs, Generic / Q000191:economics / Q000592:standards / Q000600:supply & distribution*; D006801:Humans; D055553:Prescription Drugs / Q000191:economics / Q000592:standards / Q000600:supply & distribution*; D011786:Quality Control; D014481:United States; D014486:United States Food and Drug Administration / Q000191:economics / Q000592:standards*
chemical_list: D016568:Drugs, Generic; D055553:Prescription Drugs