Lecture 1: History of drug regulation Flashcards
(41 cards)
What happened in 1854
1854 Cholera outbreak: Led to the establishment of ad hoc patchwork health boards in New Brunswick and Upper Canada to deal with outbreak.
- Infections spread, resorted to quarantine to avert pandemic
- Patchwork health system inadequate
- Poor sanitation – contaminated water spread
After Confederation what acts did the Parliament pass
1) Quarantine Act – to allow federal officials to inspect arriving ships for sick passengers
2) Sick Mariners Act – which provided special medical services for seaman that fall ill on Canadian waters or at Canadian ports.
WHat new legislation established the Department of Health in Canada in 1919
Responsibilities included all matters pertaining to public health:
- Medical examination of immigrants and Canadian seaman
- Health promotion within the public service
- Collection, publication, dissemination of health information and advisories.
How did the depatment of Health mandade expand in 1928
began dispensing and administering medical and convalescent care, job retraining, and pensions for returning war veterans.
- Renamed Pensions and National Health
What happened after WWII
Following WWII, repatriation of thousands of Canadian soldiers led to major government reorganizations.
In 1944 created Department of Veterans Affairs and Department of National Health and Welfare.
What was included in the Department of National Health and Welfare (1944-1993)
- Responsible for everything related to the promotion and preservation of health, social security, and welfare
- Research public health issues
- Medical examination of immigrants and seaman
- Administration of hospitals
- Supervision of public health aspects of transportation
- Health promotion within the public service
- Collection/dissemination of health information/stats
- Cooperation with provincial health authorities
Post WWII the Department of National Health and Welfare administered:
- Food and Drugs Act
- Canada Health Act
- Narcotic Control Act
- Quarantine Act
- Fitness and Amateur Sports Act
- Canada Pension Plan Act
- Old Age Security Act
- Family Allowances Act
- Vocational Rehabilitation of Disabled Persons Act
- Canada Assistance Plan Act
What was the 1993 reorganization
Welfare responsibilities transferred to the new Department of Human Resources Development
Department of National Health and Welfare was renamed the Department of Health.
Structure of the Department of Health (1993-2002):
- Health Protection branch
- Health Services Promotion branch
- Medical Services branch
- Fitness and Amateur Sports branch
- Income Security branch
- Social Service Programs branch
- Policy, Planning and Information branch
- Intergovernmental and International Affairs branch
- Communications branch
Structure of Health Canada (2002-current):
**Branches:
**
- Audit and Accountability Bureau
- Chief Financial Officer Branch
- Communications and Public Affairs Branch
- Corporate Services Branch
- Departmental Secretariat
- First Nations & Inuit Health Branch
- Health Products & Food Branch
- Healthy Environments & Consumer Safety Branch
- Legal Services
- Pest Management Regulatory Agency
- Regions and Programs Bureau
- Strategic Policy Branch
Agencies:
- Canadian Institutes of Health Research
- Patented Medicines Prices Review Board
- Public Health Agency of Canada
Act vs Regulation
**Act: **Legislation (law). A Bill requires Royal Assent to become Law.
Regulation: Subordinate legislation. Defines the application and enforcement of an Act.
Amendment to the inland revenue act (1875)
Canada’s first consumer protection law
Health Products & Food Branch
Therapeutic products directorate (TPD)
Biologics and genetic therapies directorate (BGTD)
Medical Devices Directorate (MDD)
Non-prescription and natural health products directorate (NNHPD)
Veterinary drugs directorate (VDD)
Amend the act respecting inland revenue
An Act to Impose License Duties on Compounders of Spirits and to amend the Act Respecting Inland Revenue to Prevent the Adulteration of Food, Drink and Drugs
Definition: adulterated “all articles of food with which was included any deleterious ingredients or any material of less value than is understood by the name.”
Inland Revenue Act (1875)
Four consumer protection provisions:
1) Workable terminology: Drugs were defined as “all articles used for curative or medicinal purposes”
2) Established standards through licensing
3) Imposed requirements for proper labelling and advertisement by manufacturers
4) Sanctions to allow government to train inspectors.
Adulteration Act
(AA; 1884) “An Act to Amend and to Consolidate as Amended the Several Acts Respecting the Adulteration of Food and Drugs”
Response to 1881 report
Adulteration Act (AA)
- Adhered to the four consumer protection provisions of the Inland Revenue Act (1875)
- Separate regulatory regime for Food, Drugs, and Liquor
- Updated definition of “drugs” with reference to “medicines for internal or external use”
- Aligned drug manufacturing standards in Canada with British or American Pharmacopoeia
- Further amendments were made over the years that strengthened the four principles.
Adulteration Act (AA)
AA – change to Department mandates
- 1915 Labelling standards were strengthened
- 1918 (post WWI) AA authority transferred from Department of Customs and Inland Revenue to the Department of Trade and Commerce
- 1919 AA was transferred to the new Food and Drugs Division of the new Department of Health
- 1920 AA was repealed and replaced with the Food and Drugs Act
- Modeled more heavily after the US Food and Drugs Act of 1906
1920 Food and Drugs Act
- Four consumer protection principles continue from Inland Revenue Act 1875
- Definition of drug
all medicines for internal or external use for man or animal - Standards of drug manufacture British or US Pharmacopoeia
- Label must be affixed to product with character, strength, quality and quantity
- Allowed for appointment of inspectors with powers to seize, for further analysis, food or drug products believed to be in violation of Act
- Inspectorate expanded (from 1 full time food and drug inspector pre 1920, to larger district and regional inspectorate staff by 1922) - Manufacture, advertisement, or sale of adulterated food or drug a criminal offence
1927 Act to amend the Food and Drugs Act
Revised definition of drug: All medicine for internal or external use for man or animal; and any substance or mixture of substances intended to be used for the treatment, mitigation or prevention of disease in man or animal.
- Drug definition revision requested by Department so as to expand the products covered (eg. Include antiseptics and vaccines)
Revision to structure of Act to include a schedule of drugs (Schedule B) subject to specific standards, testing, and rigorous inspection
- Schedule B drugs were biologics (strophanthus, digitalis, ergot, adrenalin) considered very potent and requested by physicians to be subject to greater control
Revision to Act: stricter drug labeling standards in line with labeling standards currently in place for food.
- Again, with the purpose to protect the public from drug adulteration and misbranding
Revision to Act: Government can hold a inspector-seized drug indefinitely
1936 Act to amend the Food and Drugs Act
Expanded the definition of drug to include cosmetics and articles used in the diagnosis, treatment, mitigation, or prevention of disease in man or animal.
- Effectively expanding the definition of drug to medical devices
Thalidomide prompts large scale changes to FDA
+ Thalidomide approved for sale in Canada in 1960 under the brand names Kevadon (William S. Merrill Company) and in 1961 under the brand name Talimol (Frank W. Horner Company)
+ Previously approved in Germany and the UK (safe?)
+ 1960 indicated as a sedative
+ Regarded as a “wonder drug”
+ Prescribed to pregnant women to treat morning sickness (anti-nausea)
+ Target of drug? Mechanism of action?
Ito et al. Science 327(5971):1345-1350, 2010.
Thalidomide prompts large scale changes to FDA
In Canada, approximately 100 deformed babies were born to mother’s prescribed thalidomide during the first trimester of pregnancy.
March 1962 Department of National Health and Welfare pulled all thalidomide containing drugs from hospitals and pharmacies across Canada
1962 Health Minister’s recommendations
1) Review of drug approval process by College of Physicians and Surgeons
2) Changes to the F&D Act & Regulations
*Amended FDA quickly received Royal Assent (December 1962)
1963 Changes to the FDA / FDR
A. Added Section H to the FDA “Restricted drugs”
- Criminal offence to sell thalidomide (and LSD)
B. Strengthened federal government powers to restrict sale of drugs in Canada
- Health-care professionals no longer able to give drug samples
- Added additional Regulations to better control distribution and sale of drugs
C. Greater oversight of clinical trials
- Immediate reporting of serious adverse events
- Government has the power to stop a clinical trial and must approve the trial investigator
D. Stronger emphasis on the strength of the clinical data submitted and review thereof during NDS review
E. Stronger emphasis on post-market drug surveillance
F. Significant changes to the structure of the NDS
