It is no surprise that a recent investigation by the Toronto Star found that, since 2008, at least 40 Canadian pharmaceutical companies have not only hidden, altered and destroyed data showing that their pharmaceutical products were tainted and unsafe, but also neglected to report evidence of side-effects experienced by patients when taking their medications.
The Star obtained records from the US Food and Drug Administration through the U.S. Freedom of Information Act because the US FDA inspects Canadian and international facilities when drugs that are manufactured in these facilities are intended to be distributed in the United States; however, unlike the FDA, which publicly posts investigation dates and results on its website, Health Canada does not transparently enforce drug manufacturing laws. Therefore, Canadian physicians and the public remain unaware of the problems that are revealed through any Canadian investigation. The FDA website provides dozens of warning letters to Canadian companies, detailing the atrocious conditions in these drug manufacturing facilities. In general, Health Canada conducts only a small fraction of the number of investigations that the FDA conducts.
Canadian generic giant, Apotex, has been cited for not only serious manufacturing violations, but also failing to report undesirable test results, as well as tampering with bacterial growth test records. Since 2008, the FDA has inspected Apotex at least nineteen times. In sixteen of these 19 investigations the FDA found that Apotex employed "objectionable" practices and had "repeated deficiencies". In one case, the FDA indicated that Apotex "failed to uphold 'its legal obligation'". These findings were not challenged by Apotex. Furthermore, the FDA has requested that Apotex investigate whether its middle and top management employees have been involved in data manipulation.
Taro Pharmaceuticals, Canadian generic manufacturer, was cited for keeping drugs on the market even though company testing showed that batches of the medication deteriorated prior to the expiry date indicated on the product label. Cangene Corp., another Canadian drug manufacturer failed to report of side-effects to authorities. These side-effects included, but were not limited to, blood clots and fever associated with their products. Although these findings were a result of US FDA investigation, the report also shows that the same drugs in question would have been prescribed to Canadians as well. Therefore, Health Canada would have been required to investigate these same drug manufacturers, but information about Health Canada's investigations are not made public. Canadian pharmaceutical policy expert Alan Cassels stated that "Health Canada is giving the least amount of information that they can...Instead of actually increasing people's confidence in the system, this kind of secrecy is degrading it." Cassels asks, "What's the reason for all the secrecy?"
Furthermore, the US FDA has instituted import bans on drugs made by Apotex (in India) and Ranbaxy, an India-based generic manufacturer, which also distributes pharmaceuticals to North America. The FDA found that India facilities are supplying Canada with medications that the US FDA knows have been adulterated. Following FDA inspections in 2008, the US government banned imports from two Ranbaxy facilities in India, which also distribute pharmaceuticals to Canada. In 2013, Ranbaxy's US subsidiary paid $500 million in criminal fines ($150 million) and settlements ($350 million) for its "false, fictitious, and fraudulent statements" to the FDA regarding its drug data and adulterated medications.
Terence Young, Member of Parliament for Oakville, Ontario has introduced Bill C-17 (Vanessa's Law), which aims to protect Canadians from unsafe drugs. Bill C-17 is proposed as an Act to amend the Food and Drugs Act. Alongside the Plain-Language Labeling, Bill C-17 will protect Canadians who take both prescription and over-the-counter medications by requiring more comprehensive safety warnings from drug manufacturers, giving Health Canada the power to order unsafe drugs off of the Canadian market when dangers become clear, require mandatory adverse drug reaction reporting, and create a robust warning system for patients. As of September 18, 2014, Bill C-17 has undergone its Second Reading in the Senate and has been referred to the Standing Senate Committee on Social Affairs, Science and Technology.
Part 2: FDA Investigation "Finds Trash Bags of Data"
Companies Knew Drugs They Sold Were Defective
Drug company experts advised staff to withhold data about SSRI use in children
Email: AstraZeneca Knew in 1997 that Seroquel Caused Weight Gain
DIDA: Justification Document 'Seroquel' Weight Gain - April 5 2001
DIDA: Merck Vioxx DodgeBall Cards (Original)
The Power of Pills
From Evidence-based Medicine to Marketing-based Medicine: Evidence from Internal Industry Documents
Implications of Pharmaceutical Industry Funding on Clinical Research
Seroxat and the suppression of clinical trial data: Regulatory failure and the uses of legal ambiguity