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.
- Changes to our Food and Drugs Act are now being proposed that would formalize and expand this backdoor access potentially resulting in more novel, under-tested, high-risk drugs and medical devices being given to healthy Canadians.
- 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.