Healthy Skepticism Library item: 17024
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: Electronic Source
Silverman E
Here Are Those FDA Warning Letters
Pharmalot 2010 Jan 14
http://www.pharmalot.com/2010/01/here-are-those-fda-warning-letters/#more-20900
Notes:
Links for Bayer(http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM197229.pdf), Lilly(http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM197227.pdf), Cephalon (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM197236.pdf) and Amylin (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM197236.pdf). And here are the promotional materials from Cephalon (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM197228.pdf), Bayer (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM197231.pdf) and Lilly (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM197258.pdf).
Full text:
Earlier this week, the FDA posted warning letters on its site to four drugmakers – Lilly, Bayer, Amylin Pharmaceuticals and Cephalon – for making inaccurate or incomplete statements while promoting their drugs. Amylin, for instance, was tagged because its reps made remarks that Byetta can be used as a stand-alone therapy, which was before the drug received that approval.
Bayer was chastised for suggesting its Mirena contraceptive women help would feel more romantic or intimate when, in fact, the side effects indicate the opposite may occur. A dosing card for Cephalon’s Treanda, which treats chronic lymphocytic leukemia and non-Hodgkin’s lymphoma, minimized risk and a Lilly promotional piece for its Cymbalta antidepressant minimized risk and overstated efficacy.
As The Pink Sheet points out, by issuing the letters in one fell swoop, the FDA may succeed in bringing more attention to violations, rather than letting them out in dribs and drabs.
In any event, here are the letters…
for Bayer, Lilly, Cephalon and Amylin. And here are the promotional materials from Cephalon, Bayer and Lilly that generated the heat.
