TO THE EDITOR:
At first glance, Temple and Stockbridge (1) present an apparently reasonable rationale for the FDA's approval of the heart failure drug BiDil (NitroMed, Lexington, Massachusetts) with a race-specific label for use only in “self-identified black patients.” Upon closer examination, however, their arguments fail to convince. Bibbins-Domingo and Fernandez (2) clearly show the limits of the post hoc subgroup analysis that the FDA used to justify the race-specific approval.
Beyond this, it is worth noting that since BiDil's approval, NitroMed—BiDil's corporate marketer—has made much of a recent FDA announcement that the coadministration of the much cheaper generic components ...
References
- 1.
Temple R ,Stockbridge NL . BiDil for heart failure in black patients: The U.S. Food and Drug Administration perspective. Ann Intern Med. 2007;146:57-62. [PMID:17200223 ] LinkGoogle Scholar - 2.
Bibbins-Domingo K ,Fernandez A . BiDil for heart failure in black patients: implications of the U.S. Food and Drug Administration approval. Ann Intern Med. 2007;146:52-6. [PMID:17200222 ] LinkGoogle Scholar - 3. NitroMed. FDA confirms no drugs are therapeutically equivalent to BiDil [Press release]. Lexington, MA: NitroMed; 4 May 2006. Accessed at phx.corporate-ir.net/phoenix.zhtml?c=130535&p=irol-newsArticle&ID=852400&highlight= on 4 January 2007. Google Scholar
- 4. Center for Drug Evaluation and Research approval package for application number NDA 20-727: administrative/correspondence reviews. Accessed at www.fda.gov/cder/foi/nda/2005/020727_S000_Bidil_AdminCorres.pdf on 4 January 2007. Google Scholar
- 5.
Kahn J . How a drug becomes “ethnic”: law, commerce, and the production of racial categories in medicine. Yale J Health Policy Law Ethics. 2004;4:1-46. [PMID:15052858 ] MedlineGoogle Scholar - 6. Proceedings of the U.S. Food and Drug Administration Center for Drug Evaluation and Research Cardiovascular and Renal Drugs Advisory Committee, Gaithersburg, Maryland, 16 June 2005 [Transcript]. Rockville, MD: U.S. Food and Drug Administration; 2005. Accessed at www.fda.gov/ohrms/dockets/ac/05/transcripts/2005-4145T2.pdf on 4 January 2007. Google Scholar
Author, Article, and Disclosure Information
From Hamline University School of Law, St. Paul, MN 55104.
Disclosures: Dr. Kahn testified at the FDA Advisory Committee hearing on BiDil and urged that it be approved without a race-specific label.
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