[INTERVIEW] Govt to Rush Novel Drugs to Market Before Proven Safe -Dr Susan Natsheh & Judy Stinson

*Submissions to stop the proposed Food and Drugs Act changes must be submitted by Wednesday, April 26. Details below.

Dr. Susan Nathsheh, MD, and Judy Stinson, former CBC journalist, join us to sound the alarm on how the govt is putting Canadians at risk.

"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."

Further proposed amendments to the Food and Drugs Act will put Canadians at even greater risk of harms from novel therapeutics, but Canadians can have a say in this quickly shifting balance between safe treatments and Big Pharma's access to lucrative markets by submitting comments to the Canada Gazette, and Bruno Rodrigue, Executive Director, Office of Legislative and Regulatory Modernization, Health Products and Food Branch, Department of Health (email: lrm.consultations-mlr@hc-sc.gc.ca) and your MP by Wednesday, April 26. (See below.)

Call To Action
-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. Canadian patients are not negotiable commodities for Big Business and must be protected.

-Demand immediate disclosure of any funds received from any for-profit entity benefiting from these changes by any public official, political party, or any bonus received by any civil servant involved in facilitating these regulatory changes. Demand public disclosure of any public servants or their associates attending World Economic Forum-related meetings.

-Insist on an immediate re-examination of all proposed regulatory changes to the Food and Drugs Act by qualified independent health professionals and public representatives who are free from conflicts of interest.

-Demand that Canadian safety be re-prioritized by setting prudent, transparent, objective, safety criteria for all products and devices that cannot be manipulated for political or economic gain.

-Insist on legislation that prevents politicians from pressuring civil servants to lower regulatory standards for industry gain at the expense of public safety.

–Send a clear message that when the speed of science outpaces the speed of public safety, Canadians are put at risk.
Please take 5 minutes to express your concern to Health Canada by April 26, 2023. All comments submitted to Canada Gazette, Part I, will be posted online after the comment period closes:

-Submit a Regulatory Comment for the Proposed Regulatory Text limited to 20,000 characters via Canada Gazette website – OR –

-Contact Bruno Rodrigue, Executive Director, Office of Legislative and Regulatory Modernization, Health Products and Food Branch, Department of Health, Address Locator: 3000A, 11 Holland Avenue, Suite P2108, Ottawa, Ontario K1A 0K9 (email: lrm.consultations-mlr@hc-sc.gc.ca)

Contact your MP to express your concerns! Demand an immediate re-examination of the “Advanced Therapeutics Product Pathway”, and an investigation into the individuals involved in creating this industry-favouring backdoor access that places Canadians at risk of product harm by pushing novel products to the market without first proving their safety and efficacy. Find your MP here: https://www.ourcommons.ca/members/en/search

Sample Comment

Here is sample letter / text for submission to the Gazette/Mr. Bruno Rodrigue:

Attn: Bruno Rodrigue
Executive Director
Office of Legislative and Regulatory Modernization
Health Products and Food Branch
Department of Health, 3000A
11 Holland Avenue
Suite P2108
Ottawa, Ontario K1A 0K9
lrm.consultations-mlr@hc-sc.gc.ca

I am contacting you to express my concerns about these proposed regulatory changes and the attempt to push innovation over safety.

Historically Canada has held to the highest regulatory standards by ensuring all medical products were PROVEN SAFE and effective prior to being released to the public, using Randomized Controlled Trials to ensure that the benefits outweigh the risks.

I am opposed to the Part I, Volume 156, Number 51: Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Agile Licensing) and any other regulatory changes that would remove the requirement that all drugs, medical devices, veterinary and similar products are first PROVEN safe through rigorously conducted randomized controlled trials BEFORE market authorization. I am also opposed to changes that centralize the process and increase the control of a single individual, such as the Minister of Health.

No civilized society would ever sacrifice the safety of their citizens on the altar of innovation.

All Canadians deserve to have a government and bureaucracy that are committed to putting their interests first and maintaining the highest safety standards. Therefore, I insist on an immediate re-examination of the Advanced Therapeutic Products Pathway and all proposed regulatory changes to the Food and Drugs Act, by qualified independent health professionals and public representatives who are free from conflicts of interest and who will ensure that all products are proven safe before being given market authorization.

Health Canada has a fiduciary responsibility to protect Canadians from pharmaceutical abuse and not to promote innovation.

I further insist that the safety of Canadians be re-prioritized by setting prudent, transparent, objective, safety criteria for ALL products and devices that cannot be manipulated for political or economic gain.

Sincerely,