Canadian government to require drug shortage notice

[February 11, 2015] By Rod Nickel

WINNIPEG, Manitoba (Reuters) - The Canadian government will require pharmaceutical companies to post public notices when drugs are not available or face fines, Health Minister Rona Ambrose said on Tuesday.

Posting notices to a website about shortages is currently voluntary. The website, www.drugshortages.ca, lists more than 200 recent shortages of drugs made by companies including Valeant Pharmaceuticals Inc, GlaxoSmithKline PLC and Pfizer Canada.

Reasons for shortages include manufacturing problems and unexpected increases in demand.

Drugmakers are already required in the United States to notify the Food and Drug Administration about shortages, including the reasons and expected duration.

Ambrose said in Vancouver that the voluntary system hasn't worked well enough, citing an example of an unnamed drug company that refused to post information about the shortage of a cancer drug.
 

"It became clear to me that Canadians were not getting this essential information in a timely and reliable manner from all pharmaceutical companies," she said.

Drug companies will be required to report actual and anticipated shortages on a website to be developed, once regulations take effect. In the meantime, manufacturers will be expected to post information on the voluntary site.

The federal health department will also publicly list drug companies that commit to notification and post online letters to manufacturers that do not disclose information about shortages.

"This public register will name and shame those pharma companies," Ambrose said.

Canada's Research-Based Pharmaceutical Companies, an association whose members include Merck Canada and Bristol-Myers Squibb Canada, said it supported the move and that generic drug companies are connected with most drug shortages.

But Jeff Connell, vice president of corporate affairs for the Canadian Generic Pharmaceutical Association, said that for some brand-name drugs there are up to 12 generic versions.

"Simple mathematics dictates that if, for example, there is a shortage of an active ingredient used to make a drug, this will impact one brand-name drug manufacturer but several generic drugs manufacturers," Connell said.

(Reporting by Rod Nickel in Winnipeg, Manitoba; Editing by Alan Crosby and Meredith Mazzilli)

[© 2015 Thomson Reuters. All rights reserved.]

Copyright 2015 Reuters. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.