Pharmafia & Ottawa rush high-risk drugs


Tue, Apr 18 at 2:32 a.m.

Say NO to any and all food and drug regulatory amendments that would permit the authorization of any product or device, especially novel potentially high-risk drugs and/or marketed as preventative medicines that have not first been PROVEN safe and effective through rigorously conducted randomized controlled trials utilizing a neutral placebo. 

  • In 2019 a backdoor to the Food and Drugs Act was created to reduce protective requirements in the safety approval process for Advanced Therapeutic Products. This created a fast-track framework known as the Advanced Therapeutic Products (ATP) Pathway for Big Pharma to rush novel potentially high-risk drugs to Canadians without first proving their safety and efficacy.
  • Positioned as “advancing innovation” and “promoting life-saving therapies” this subjective, arbitrary, and more centralized process places an inappropriate level of control in the hands of the Minister of Health.
  • These changes would also  apply to the regulation of veterinary products, bypassing the in-depth studies needed to assess the impact on our food safety.

By piotrbein