Healthy Skepticism Library item: 15500

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Publication type: report

Lexchin J
Drug Safety and Health Canada: Going, Going…Gone?
: Canadian Centre for Policy Alternatives 2009 Apr
http://www.policyalternatives.ca/~ASSETS/DOCUMENT/National_Office_Pubs/2009/Drug_Safety_and_Health_Canada.pdf

Abstract:

Drug safety is a serious issue and is increasing in prominence. In Canada 3–4% of drugs approved
will eventually be withdrawn from the market because of safety issues, but the number of people exposed to these drugs is increasing because of aggressive marketing tactics by the pharmaceutical industry.
The Food and Drugs Act and its regulations theoretically give Health Canada considerable authority in dealing with safety issues, but there are also significant limitations in the legislation. Although the organization can cancel the market
authorization for drugs without prior negotiations
with companies, it cannot force them to recall drugs deemed harmful from pharmacy shelves. Health Canada can issue a public warning
about a drug without the agreement of the company involved, but it cannot directly compel the company to revise the label of its product to reflect new safety information.
The priorities of Health Canada are skewed in favour of rapid approval of new drugs at the expense of the post-marketing pharmaco-surveillance
system as judged by how money and personnel are allocated to each activity.
Faster approval of new drugs has the potential to produce more safety problems once drugs are on the market, especially since Health Canada faces financial penalties if it exceeds targets for the length of time that products spend in the approval process.
Although Health Canada has committed itself to defined standards with regard to drug approval times, it has explicitly rejected developing
quantitative standards for evaluating its post-marketing pharmaco-surveillance system. In addition to lacking standards in this area, it has not made clear what its criteria are in issuing risk communication documents, and it does not monitor whether or not those communications have had the desired effect in terms of changing
the way that drugs are prescribed and used.
Adverse drug reactions (ADRs), even serious
ones, are significantly under-reported, but mandatory reporting does not seem to improve reporting rates in countries where it has been implemented. New Zealand has the highest rate of reporting of ADRs in the world, due to a variety
of methods, including the feedback that it provides to individuals filing reports and outreach
strategies to emphasize the importance of reporting ADRs. Many of the features that the New Zealand system uses are ignored or inadequately
implemented in Canada.
Wide dissemination of safety information is necessary to allow practitioners to prescribe appropriately, and for consumers to use drugs wisely. Health Canada, however, continues to treat all such data that companies submit in order
to get a new drug approved as confidential business information that will not be publicly released without the consent of the company owning the data. What safety information it does release is insufficient to allow an adequate independent
assessment of a drug’s safety.
Progressive licensing is a new regulatory model
that Health Canada is proposing to introduce that would allow it to retain regulatory control over a drug throughout the product’s entire life-cycle, instead of effectively losing control once the product is marketed, as is now the case. However,
in its initial incarnation in the form of Bill C-51, progressive licensing would have actually further strengthened Health Canada’s reliance on the industry for information and would have worked to enhance regulatory secrecy.
Canada’s post-marketing pharmaco-surveillance
system could be significantly improved through a series of reforms undertaken by Health Canada, including:
• Health Canada should utilize the powers that it is given through the Food and Drugs Act to protect people’s health rather than delay action through negotiations with drug companies.
• Health Canada needs to reorient its priorities so that post-marketing pharmaco-surveillance is on an equal footing with the approval of new drugs.
• Health Canada needs to devote significantly more resources to its post-marketing pharmaco-surveillance system.
• Health Canada should undertake a systematic study to examine whether faster drug approvals lead to more post-marketing safety issues.
• Health Canada needs to develop measurable standards to judge its post-marketing pharmaco-surveillance system.
• Health Canada needs to publicly and transparently explain what criteria it uses in issuing safety communications.
• Health Canada needs to systematically analyze whether its methods of communicating with health care professionals and the public are producing the desired effects.
• Health Canada should study the methods that New Zealand uses in its post-marketing ADR system and adapt them for Canadian use.
• Health Canada needs to stop treating safety information as confidential and commit to making all safety information publicly available promptly after approving a new drug.
• Health Canada should use progressive licensing in order to decrease its dependence on industry for information by ensuring that post-marketing studies are undertaken, analyzed, and reported on, independent of industry. Furthermore, progressive licensing should enhance the transparency of safety information rather than further secrecy.