February 17, 2008

Mike Leavitt, Secretary
Department of Health and Human Services
200 Independence Avenue, SW
Washington, DC 20201


Dear Secretary Leavitt,


We, the undersigned, request that the efficacy of the generic form of Wellbutrin XL (bupropion), known as Budeprion XL, be investigated. Many patients have become depressed after switching from the brand name version of bupropion to the generic form. In general, unless a doctor specifically requests a brand name only, pharmacies will automatically fill prescriptions with generic drugs. Additionally, insurance companies will often only pay for brand name medications when a generic is not available. Utilizing a potentially ineffective generic medication for the treatment of depression puts patients' health and safety at risk. Patients and physicians must be warned of the possibility of a worsening of symptoms while taking Budeprion XL. We urge you to consider the consequences of poorly controlled depression, and ask that you mandate independent testing of Budeprion XL to accurately determine its efficacy in depression.


The following links suggest the nature and extent of the problem:

NPR Recording
http://www.npr.org/templates/story/story.php?storyId=15218354

The People's Pharmacy Reports of Generic Drug Problems
http://www.peoplespharmacy.com/archives/generic_drug_problems/report_generic_drug_problem.php

Results of Consumer Lab Study Comparing Wellbutrin XL and Budeprion XL
http://www.consumerlab.com/results/wellbutrin-bupropion.asp

MSNBC Health Article
http://www.nbc6.net/msnbchealth/14327700/detail.html

Interview with CNN's Dr. Sanjay Gupta
http://transcripts.cnn.com/TRANSCRIPTS/0710/19/ltm.01.html


The following link discusses the maker of brand name Wellbutrin XL's attempts to prevent sales of the generic drug by starting a petition "intended to protect the public against the potentially harmful effects of generic versions of Wellbutrin XL that may not be a bioequivalent to Biovail's branded product, or may be misleadingly labeled."

http://www.law.com/jsp/article.jsp?id=1183626388782


The following FDA site can be used to report adverse reactions to the generic form of Wellbutrin XL:

https://www.accessdata.fda.gov/scripts/medwatch/


ACTIONS REQUESTED

Conduct independent studies on the efficacy of Budeprion XL for depressive symptoms.

Require warning labels on dispensed prescriptions of Budeprion XL to indicate that Budeprion XL may not work as well for depression as the brand name Wellbutrin XL, and warn patients and physicians to monitor for a worsening of condition while on Budeprion XL.