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Notes
Angell[2] argues that many me-too drugs are never tested at equivalent doses to show that there are significant differences in outcomes for some patients, and claims that “the idea that patients respond differently to me-too drugs is merely an untested — and self-serving — hypothesis.”
Lichtenberg[7] finds that drugs that the FDA lists as ‘priority review’ create a significant impact on population longevity, while ‘standard-review’ drugs, which have therapeutic properties the FDA considers to be similar to those of already-marketed drugs, have no discernible effect on longevity. Prices of standard-review drugs are, however, typically similar to those of the previously introduced priority-review drugs.
The use of trade names is for product identification purposes only and does not imply endorsement.
In this context, it is hard to understand the standard industry defence of me-too drugs, which consists of arguing that they are good because they lead to price reductions and competition before patent expiry.[13] If price reductions are desirable in themselves before patent expiry, why are patents so desirable?
Before the requirement for clinical superiority was introduced to the Orphan Drug Act, firms had developed and marketed almost identical products for rare diseases, which “left the biotechnology industry susceptible to a loss in the value inherent in market exclusivity”[21]
A related problem is that when a drug enters a relatively crowded market, it is not clear what the standard for approval should be. Should it be comparison with the most recent entrants, to the first entrant, or what? Requiring a demonstration of clinical superiority to six other drugs would be very expensive. Perhaps a reasonable requirement would be comparison with (at most) two therapies deemed to be most similar by the regulator.
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Acknowledgements
No sources of funding were used to assist in the preparation of this commentary. The author has no conflicts of interest that are directly relevant to the content of this commentary. This paper has benefited from the comments of an anonymous referee, and from Joseph DiMasi’s thorough response to an earlier version.
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Hollis, A. Comment on “The economics of follow-on drug research and development: Trends in entry rates and the timing of development”. Pharmacoeconomics 23, 1187–1192 (2005). https://doi.org/10.2165/00019053-200523120-00002
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DOI: https://doi.org/10.2165/00019053-200523120-00002