The effect of federal and state off-label marketing investigations on drug prescribing: The case of olanzapine.
In the past decade, the federal government has frequently investigated and prosecuted pharmaceutical manufacturers for illegal promotion of drugs for indications not approved by the Food and Drug Administration (FDA) ("off-label" uses). State governments can choose to coordinate with the f...
| Main Authors: | , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Public Library of Science (PLoS)
2017-01-01
|
| Series: | PLoS ONE |
| Online Access: | http://europepmc.org/articles/PMC5384770?pdf=render |
| _version_ | 1828770587357478912 |
|---|---|
| author | Bo Wang David M Studdert Ameet Sarpatwari Jessica M Franklin Joan Landon Aaron S Kesselheim |
| author_facet | Bo Wang David M Studdert Ameet Sarpatwari Jessica M Franklin Joan Landon Aaron S Kesselheim |
| author_sort | Bo Wang |
| collection | DOAJ |
| description | In the past decade, the federal government has frequently investigated and prosecuted pharmaceutical manufacturers for illegal promotion of drugs for indications not approved by the Food and Drug Administration (FDA) ("off-label" uses). State governments can choose to coordinate with the federal investigation, or pursue their own independent state investigations. One of the largest-ever off-label prosecutions relates to the atypical antipsychotic drug olanzapine (Zyprexa). In a series of settlements between 2008 and 2010, Eli Lilly paid $1.4 billion to the federal government and over $290 million to state governments. We examined the effect of these settlements on off-label prescribing of this medication, taking advantage of geographical differences in states' involvement in the investigations and the timing of the settlements. However, we did not find a reduction in off-label prescribing; rather, there were no prescribing changes among states that joined the federal investigation, those that pursued independent state investigations, and states that pursued no investigations at all. Since the settlements of state investigations of off-label prescribing do not appear to significantly impact prescribing rates, policymakers should consider alternate ways of reducing the prevalence of non-evidence-based off-label use to complement their ongoing investigations. |
| first_indexed | 2024-12-11T14:09:01Z |
| format | Article |
| id | doaj.art-88e6b8a0563f4518beba202b85704a84 |
| institution | Directory Open Access Journal |
| issn | 1932-6203 |
| language | English |
| last_indexed | 2024-12-11T14:09:01Z |
| publishDate | 2017-01-01 |
| publisher | Public Library of Science (PLoS) |
| record_format | Article |
| series | PLoS ONE |
| spelling | doaj.art-88e6b8a0563f4518beba202b85704a842022-12-22T01:03:31ZengPublic Library of Science (PLoS)PLoS ONE1932-62032017-01-01124e017531310.1371/journal.pone.0175313The effect of federal and state off-label marketing investigations on drug prescribing: The case of olanzapine.Bo WangDavid M StuddertAmeet SarpatwariJessica M FranklinJoan LandonAaron S KesselheimIn the past decade, the federal government has frequently investigated and prosecuted pharmaceutical manufacturers for illegal promotion of drugs for indications not approved by the Food and Drug Administration (FDA) ("off-label" uses). State governments can choose to coordinate with the federal investigation, or pursue their own independent state investigations. One of the largest-ever off-label prosecutions relates to the atypical antipsychotic drug olanzapine (Zyprexa). In a series of settlements between 2008 and 2010, Eli Lilly paid $1.4 billion to the federal government and over $290 million to state governments. We examined the effect of these settlements on off-label prescribing of this medication, taking advantage of geographical differences in states' involvement in the investigations and the timing of the settlements. However, we did not find a reduction in off-label prescribing; rather, there were no prescribing changes among states that joined the federal investigation, those that pursued independent state investigations, and states that pursued no investigations at all. Since the settlements of state investigations of off-label prescribing do not appear to significantly impact prescribing rates, policymakers should consider alternate ways of reducing the prevalence of non-evidence-based off-label use to complement their ongoing investigations.http://europepmc.org/articles/PMC5384770?pdf=render |
| spellingShingle | Bo Wang David M Studdert Ameet Sarpatwari Jessica M Franklin Joan Landon Aaron S Kesselheim The effect of federal and state off-label marketing investigations on drug prescribing: The case of olanzapine. PLoS ONE |
| title | The effect of federal and state off-label marketing investigations on drug prescribing: The case of olanzapine. |
| title_full | The effect of federal and state off-label marketing investigations on drug prescribing: The case of olanzapine. |
| title_fullStr | The effect of federal and state off-label marketing investigations on drug prescribing: The case of olanzapine. |
| title_full_unstemmed | The effect of federal and state off-label marketing investigations on drug prescribing: The case of olanzapine. |
| title_short | The effect of federal and state off-label marketing investigations on drug prescribing: The case of olanzapine. |
| title_sort | effect of federal and state off label marketing investigations on drug prescribing the case of olanzapine |
| url | http://europepmc.org/articles/PMC5384770?pdf=render |
| work_keys_str_mv | AT bowang theeffectoffederalandstateofflabelmarketinginvestigationsondrugprescribingthecaseofolanzapine AT davidmstuddert theeffectoffederalandstateofflabelmarketinginvestigationsondrugprescribingthecaseofolanzapine AT ameetsarpatwari theeffectoffederalandstateofflabelmarketinginvestigationsondrugprescribingthecaseofolanzapine AT jessicamfranklin theeffectoffederalandstateofflabelmarketinginvestigationsondrugprescribingthecaseofolanzapine AT joanlandon theeffectoffederalandstateofflabelmarketinginvestigationsondrugprescribingthecaseofolanzapine AT aaronskesselheim theeffectoffederalandstateofflabelmarketinginvestigationsondrugprescribingthecaseofolanzapine AT bowang effectoffederalandstateofflabelmarketinginvestigationsondrugprescribingthecaseofolanzapine AT davidmstuddert effectoffederalandstateofflabelmarketinginvestigationsondrugprescribingthecaseofolanzapine AT ameetsarpatwari effectoffederalandstateofflabelmarketinginvestigationsondrugprescribingthecaseofolanzapine AT jessicamfranklin effectoffederalandstateofflabelmarketinginvestigationsondrugprescribingthecaseofolanzapine AT joanlandon effectoffederalandstateofflabelmarketinginvestigationsondrugprescribingthecaseofolanzapine AT aaronskesselheim effectoffederalandstateofflabelmarketinginvestigationsondrugprescribingthecaseofolanzapine |