title: Switching omeprazole in Sweden and the United States.
abstract: This article compares the Swedish Medical Products Agency's (MPA) decision to switch omeprazole from prescription (Rx) to over-the-counter (OTC) status with the US Food and Drug Administration (FDA) advisory panel's decision not to authorize the switch. The agencies' differing perspectives on efficacy, safety, labeling, and clinical trial requirements are evaluated with regard to the Rx-to-OTC switch process in general and omeprazole's case in particular. The FDA and MPA regulatory policies on switches are substantially divergent. The FDA maintains a stricter set of switch guidelines and requirements than the MPA. One could infer from this that the FDA is more risk-averse than the MPA. Nevertheless, the omeprazole switch in Sweden appears to be an exception in that it contrasts with the MPA's historical reluctance to switch the Rx status of medications. Cost considerations appear to have triggered the omeprazole switch, making it a special case. The lessons to be drawn from this case study are both specific and general. At the specific level, this case study suggests the MPA's decision to switch omeprazole was prompted by economic considerations, whereas the FDA's mandate did not allow cost to affect its decision on omeprazole. At a general level, this case study indicates that the differences between the FDA and MPA with respect to their regulatory policies on switches and their mandates apply not only to omeprazole but also to the dozens of switches currently under consideration by the respective regulatory agencies.
authors.affiliation: Tufts Center for the Study of Drug Development, Boston, Massachusetts 02111, USA. joshua.cohen@tufts.edu
authors.forename: Joshua
authors.initials: J
authors.lastname: Cohen
mesh_terms: D000897:Anti-Ulcer Agents / Q000191:economics / Q000592:standards / Q000627:therapeutic use; D003659:Decision Making, Organizational; D017277:Drug Approval / Q000458:organization & administration*; D016527:Drug Costs / Q000592:standards*; D011307:Drug Prescriptions / Q000191:economics; D004791:Enzyme Inhibitors / Q000191:economics / Q000592:standards / Q000627:therapeutic use; D006801:Humans; D004366:Nonprescription Drugs / Q000191:economics / Q000592:standards / Q000627:therapeutic use; D009853:Omeprazole / Q000191:economics / Q000592:standards / Q000627:therapeutic use; D011785:Quality Assurance, Health Care; D013548:Sweden; D014481:United States; D014486:United States Food and Drug Administration / Q000592:standards
chemical_list: D000897:Anti-Ulcer Agents; D004791:Enzyme Inhibitors; D004366:Nonprescription Drugs; D009853:Omeprazole