Skip to main content

Main menu

  • Home
  • Content
    • Current issue
    • Past issues
    • Early releases
    • Collections
    • Sections
    • Blog
    • Infographics & illustrations
    • Podcasts
    • COVID-19 Articles
  • Authors
    • Overview for authors
    • Submission guidelines
    • Submit a manuscript
    • Forms
    • Editorial process
    • Editorial policies
    • Peer review process
    • Publication fees
    • Reprint requests
    • Open access
  • CMA Members
    • Overview for members
    • Earn CPD Credits
    • Print copies of CMAJ
  • Subscribers
    • General information
    • View prices
  • Alerts
    • Email alerts
    • RSS
  • JAMC
    • À propos
    • Numéro en cours
    • Archives
    • Sections
    • Abonnement
    • Alertes
    • Trousse média 2022
  • CMAJ JOURNALS
    • CMAJ Open
    • CJS
    • JAMC
    • JPN

User menu

Search

  • Advanced search
CMAJ
  • CMAJ JOURNALS
    • CMAJ Open
    • CJS
    • JAMC
    • JPN
CMAJ

Advanced Search

  • Home
  • Content
    • Current issue
    • Past issues
    • Early releases
    • Collections
    • Sections
    • Blog
    • Infographics & illustrations
    • Podcasts
    • COVID-19 Articles
  • Authors
    • Overview for authors
    • Submission guidelines
    • Submit a manuscript
    • Forms
    • Editorial process
    • Editorial policies
    • Peer review process
    • Publication fees
    • Reprint requests
    • Open access
  • CMA Members
    • Overview for members
    • Earn CPD Credits
    • Print copies of CMAJ
  • Subscribers
    • General information
    • View prices
  • Alerts
    • Email alerts
    • RSS
  • JAMC
    • À propos
    • Numéro en cours
    • Archives
    • Sections
    • Abonnement
    • Alertes
    • Trousse média 2022
  • Visit CMAJ on Facebook
  • Follow CMAJ on Twitter
  • Follow CMAJ on Pinterest
  • Follow CMAJ on Youtube
  • Follow CMAJ on Instagram
News

Speed up drug-approval process, feds told

Wayne Kondro
CMAJ March 05, 2002 166 (5) 644;
Wayne Kondro
Ottawa
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • Article
  • Responses
  • Metrics
  • PDF
Loading

It's time for Ottawa to stand and deliver on its long-promised overhaul of the drug-review system and approval process so that Canadians can get readier access to new medicines, a coalition of consumer-based advocacy groups says.

Although former Health Minister Allan Rock embraced recommended reforms nearly 2 years ago, the department's record is actually getting worse, say the cochairs of the Canadians for Best Medicines Second National Summit on Reform of the Drug Review System, held in Aylmer, Que., in January.

Health Canada's stated target for drug approvals is 355 days, but it took an average of 743 days to review a drug in 2000, says Pat Kelly, chair of the Cancer Advocacy Coalition of Canada (see CMAJ 2000;162[4]:501-4). “That was 152 days longer than in 1999.”

It took 985 days to approve the use of infliximab (Remicade) for the treatment of rheumatoid arthritis, adds Cheryl Koehn, summit cochair and founder of the health lobby group Arthritis Consumer Experts. “That's compared to 287 [days] in the United States.”

Koehn and Kelly attribute the situation to a lack of political will to implement reforms recommended by a Health Canada working group in August 1999. At the first Best Medicines summit in May 2000, says Koehn, “Rock embraced the recommendations, but in the end have we gotten anywhere? Have any of them been implemented? No.”

It's been estimated that an additional $28 million a year is needed to provide the staffing that would allow Health Canada's Therapeutic Products Directorate to meet the 355-day target, Kelly notes. “Every single politician stands up at the podium and says ‘the health of Canadians is my number-one priority,’ ” adds Koehn. “Well, prove it.”

Koehn and Kelly hope the summit will help pressure the government to move immediately on the 29 measures recommended to promote timely access to drugs, improve postapproval surveillance, and make the system more transparent by providing more public participation.

Summit organizers say a more rapid harmonization of the Canadian, American and European drug-review systems is needed so that conclusions drawn abroad can be adopted quickly here. “What value is added by having an independent review agency in Canada when so much of what it does is reliant on the FDA [US Food and Drug Administration] or the European Union or Australia?” Kelly asks.

“They're gathering data from a lot of other places other than Canada, so do we need to have a made-in-Canada stamp-of-approval on these new drugs that are coming onto market? Could we realize some efficiencies by looking at international harmonization?”

Following the summit, Koehn said a broad consensus had been reached to launch a campaign to press Ottawa to bolster funding for the drug-review process, including restoration of money clawed back from Health Canada because of its cost-recovery measures.

The coalition will also begin badgering MPs to account for the failure to fund the review process adequately. “We're going political,” Koehn says. “We are taking this issue to the Hill and we will not rest until they put the money back.”

PreviousNext
Back to top

In this issue

CMAJ
Vol. 166, Issue 5
5 Mar 2002
  • Table of Contents
  • Index by author

Article tools

Respond to this article
Print
Download PDF
Article Alerts
To sign up for email alerts or to access your current email alerts, enter your email address below:
Email Article

Thank you for your interest in spreading the word on CMAJ.

NOTE: We only request your email address so that the person you are recommending the page to knows that you wanted them to see it, and that it is not junk mail. We do not capture any email address.

Enter multiple addresses on separate lines or separate them with commas.
Speed up drug-approval process, feds told
(Your Name) has sent you a message from CMAJ
(Your Name) thought you would like to see the CMAJ web site.
CAPTCHA
This question is for testing whether or not you are a human visitor and to prevent automated spam submissions.
Citation Tools
Speed up drug-approval process, feds told
Wayne Kondro
CMAJ Mar 2002, 166 (5) 644;

Citation Manager Formats

  • BibTeX
  • Bookends
  • EasyBib
  • EndNote (tagged)
  • EndNote 8 (xml)
  • Medlars
  • Mendeley
  • Papers
  • RefWorks Tagged
  • Ref Manager
  • RIS
  • Zotero
‍ Request Permissions
Share
Speed up drug-approval process, feds told
Wayne Kondro
CMAJ Mar 2002, 166 (5) 644;
Digg logo Reddit logo Twitter logo Facebook logo Google logo Mendeley logo
  • Tweet Widget
  • Facebook Like

Jump to section

  • Article
  • Responses
  • Metrics
  • PDF

Related Articles

  • No related articles found.
  • Google Scholar

Cited By...

  • No citing articles found.
  • Google Scholar

More in this TOC Section

  • Monkeypox: tracking the global health emergency
  • Making sense of monkeypox death rates
  • Providing abortions to Americans could land Canadian doctors in legal trouble — without CMPA assistance
Show more News

Similar Articles

Collections

  • Topics
    • Canadian government
    • Drug regulation

 

View Latest Classified Ads

Content

  • Current issue
  • Past issues
  • Collections
  • Sections
  • Blog
  • Podcasts
  • Alerts
  • RSS
  • Early releases

Information for

  • Advertisers
  • Authors
  • Reviewers
  • CMA Members
  • CPD credits
  • Media
  • Reprint requests
  • Subscribers

About

  • General Information
  • Journal staff
  • Editorial Board
  • Advisory Panels
  • Governance Council
  • Journal Oversight
  • Careers
  • Contact
  • Copyright and Permissions
  • Accessibiity
  • CMA Civility Standards
CMAJ Group

Copyright 2022, CMA Impact Inc. or its licensors. All rights reserved. ISSN 1488-2329 (e) 0820-3946 (p)

All editorial matter in CMAJ represents the opinions of the authors and not necessarily those of the Canadian Medical Association or its subsidiaries.

To receive any of these resources in an accessible format, please contact us at CMAJ Group, 500-1410 Blair Towers Place, Ottawa ON, K1J 9B9; p: 1-888-855-2555; e: cmajgroup@cmaj.ca

Powered by HighWire