OTTAWA, ONTARIO, CANADA — Canada needs to modernize its pharmaceutical drug laws to ensure that new drugs as well as older drugs are safe for Canadians, states an editorial in CMAJ (Canadian Medical Association Journal) http://www.cmaj.ca/cgi/doi/10.1503/cmaj.110489.
“Canadians are left inadequately protected by a federal Food and Drugs Act that’s a dusty relic, virtually untouched since 1953,” writes Dr. Paul Hébert, Editor-in-Chief, with coauthors. “This leaves Health Canada with the Herculean task of ensuring that both old and new medications are as safe as they are effective without the powers, regulatory tools or resources to do so.”
New drugs are often released based on scant understanding of the safety of the drug compounds, which can cause serious health effects and even death, as the examples of rofecoxib (Vioxx) for arthritis, rosiglitazone (Avandia) for diabetes and tegaserod (Zelnorm) for irritable bowel syndrome show.
“The federal election offers a chance to spur government action, or at least extract promises from federal parties, to create a food and drug act that will do everything possible to ensure medications, new and old, are safe and effective,” state the authors.
Reform includes increasing the level of evidence gathering to support the safety of a drug, increased monitoring after release of a drug, progressive licensing and modernizing legislation to bring it to similar standards in the United States and the European Union.
Media contact: Kim Barnhardt, Senior Strategist, Communications and Partnerships, CMAJ, 613-520-7116 x2224, [email protected]