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Healthy Skepticism Library item: 8520

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: Journal Article

Lexchin J.
A comparison of new drug availability in Canada and the United States and potential therapeutic implications of differences.
Health Policy 2006 Dec; 79:(2-3):214-20


BACKGROUND: Claims are made that new valuable drugs are not available in Canada at the time that they are marketed in the United States. This study uses a convenience sample of new drugs marketed in the United States and determines how many of these products are initially unavailable in Canada and their therapeutic value.

METHODS: Issues of the Canadian edition of The Medical Letter from May 12, 2003 to June 21, 2004 were hand searched for evaluations of new drugs and the following information was recorded: indication, availability in Canada and conclusions about therapeutic value. For drugs not available in Canada two clinical pharmacologists rated the therapeutic value of the products and the type of FDA review (standard or priority) was recorded. A database from the Therapeutic Products Directorate was searched to see if any of the drugs initially unavailable were subsequently marketed.

RESULTS: Thirty-two of 37 drugs were not available in Canada. Between 9 and 11 of these products were rated as offering moderate to significant therapeutic gains. Twelve of the 32 drugs eventually were marketed in Canada.

INTERPRETATION: Although the majority of new drugs marketed in the United States but not available in Canada do not offer any therapeutic advantage, between about a quarter and a third of may offer moderate to significant therapeutic gains. The reasons why these drugs are unavailable and how much their absence affects the treatment Canadians receive should be the subject of future research.

Publication Types: Comparative Study MeSH Terms: Canada Drug Approval* Humans Pharmaceutical Preparations/supply & distribution* Review Literature United States Substances: Pharmaceutical Preparations


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