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FED drug class > Lecture 1: History of drug regulation > Flashcards

Lecture 1: History of drug regulation Flashcards

1
Q

What happened in 1854

A

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
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2
Q

After Confederation what acts did the Parliament pass

A

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.

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3
Q

WHat new legislation established the Department of Health in Canada in 1919

A

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.​
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4
Q

How did the depatment of Health mandade expand in 1928

A

began dispensing and administering medical and convalescent care, job retraining, and pensions for returning war veterans.​

  • Renamed Pensions and National Health​
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5
Q

What happened after WWII

A

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.​

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6
Q

What was included in the Department of National Health and Welfare (1944-1993)​

A
  • 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​
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7
Q

Post WWII the Department of National Health and Welfare administered:

A
  • 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
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8
Q

What was the 1993 reorganization

A

Welfare responsibilities transferred to the new Department of Human Resources Development ​

Department of National Health and Welfare was renamed the Department of Health.

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9
Q

Structure of the Department of Health (1993-2002):

A
  • 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​
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10
Q

Structure of Health Canada (2002-current):

A

**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​

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11
Q

Act vs Regulation

A

**Act: **Legislation (law). A Bill requires Royal Assent to become Law.​

Regulation: Subordinate legislation. Defines the application and enforcement of an Act.

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12
Q

Amendment to the inland revenue act (1875)

A

Canada’s first consumer protection law

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13
Q

Health Products & Food Branch​

A

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)

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14
Q

Amend the act respecting inland revenue

A

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.”​

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15
Q

Inland Revenue Act (1875)

A

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.

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16
Q

Adulteration Act

A

(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.
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17
Q

Adulteration Act (AA)

A

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​

18
Q

1920 Food and Drugs Act

A
  • 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
19
Q

1927 Act to amend the Food and Drugs Act

A

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

20
Q

1936 Act to amend the Food and Drugs Act

A

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​

​

21
Q

Thalidomide prompts large scale changes to FDA

A

+ 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.​

​

22
Q

Thalidomide prompts large scale changes to FDA

A

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

23
Q

1962 Health Minister’s recommendations

A

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)

24
Q

1963 Changes to the FDA / FDR

A

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

25
Q

1963 FDR: Creation of
Division 8

A

New definition of a “new drug”
“(a) a drug that contains or consists of a substance, whether as an active or inactive ingredient, carrier, coating, excipient, menstruum or other component, that has not been sold as a drug in Canada for sufficient time and in sufficient quantity to establish in Canada the safety and effectiveness of that substance for use as a drug;”

26
Q

1963 Division 8 NDS

A

New Drug Submission (NDS):
+Review to take 120 days versus previous 90 days
+Content of NDS to include:​
- Decription of new drug, proper name, brand name​
- A quantitative list of all ingredients and specifications​
- Names, address of manufacturers of ingredients​
- Description of manufacturing process​
- Description of controls used in manufacturing​
- Details of the tests performed on the drug product (to control potency, purity, stability, safety)​
- Reports of above safety tests​
- Evidence of clinical effectiveness​
- Labels to be used, route of admin, proposed dosage, contra-indications, side effects​
- Pharmaceutical form drug will be sold

27
Q

1965-1968: Additional changes to Food and Drugs Directorate​

A
  • Increase in size of Directorate personnel​
  • Drug manufacturers / distributors need to be registered with Directorate​
  • Implementation of lot release program ​
  • new Regulations to govern drug importation into Canada
28
Q

1990s: New Drug Licensing Framework

A
  • Every brand name of a drug receives a unique Drug Identification Number (DIN) (1992)
  • Adverse Drug Reaction Reporting (post-market surveillence) added into the FDR (1995)
  • Changes increasingly conforming to international regulations (international harmonization)
  • Risk/Benefit ratio
29
Q

Recent amendments

A

2014: Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law) Amendments to the Food and Drugs Act (Bill C-17)​

  • First reading on December 6, 2013​

+Bill brought before Parliament by MP Terrence Young​

+Bill in response to the death of 15 year old Vanessa Young (2001)​

++Cisapride (Prepulsid) serotonin 5-HT4 receptor agonist used to increase GI motility​

++Bulemic (electrolyte imbalance)​

++Young’s pharmacist was not aware of ventricular arrhythmias​
+++ 80 serious (fatal) ADRs associated with Cisapride at the time in US/CAN​
+++ Currently 16 ADRs for Cisapride and arrhythmias in Canada​

  • Royal Assent on November 11, 2014
30
Q

2014 Vanessa’s Law

A

Enhanced post-market drug surveillance
- Mandatory adverse drug reaction reporting by healthcare institutions

Authority to recall unsafe therapeutic products;
- New penalties for unsafe products: jail, and new fines of up to $5 million per day instead of the current $5,000​
- Provide the courts with discretion to impose even stronger fines if violations were caused intentionally;

Compel drug companies to revise labels to clearly reflect health risk information, including potential updates for health warnings for children​

Compel drug companies to do further testing on a product, including when issues are identified with certain at-risk populations such as children.​

Mandatory clinical trial registration​

New regulation making powers​

31
Q

Current Structure of the FDA

A

Part 1 FOODS, DRUGS, COSMETICS AND DEVICES
- Sale and importation, powers to require information*

Part 2 ADMINISTRATION AND ENFORCEMENT
- Marketing authorization and inspections, punishments

Part 3 and 4 SCHEDULES
Schedule A
- List of diseases, disorders, or abnormal states for which advertisement is prohibited for drugs

Schedule B
- List of standards (eight)

Schedule C
- Radiopharmaceuticals

Schedule D
- Biologics

32
Q

Food and Drug Regulations

A

Part A – Administration
Part B – Foods
Part C – Drugs
Part D – Vitamins, Minerals, and Amino Acids
Part E – Cyclamate and Saccharin Sweeteners
Part G – Controlled Drugs
Part J – Restricted Drugs

33
Q

Part C – Drugs

A

Division 1 – All drugs, general information and definitions​
Division 1A – Establishment Licences​
Division 2 – Good manufacturing practices​
Division 3 – Schedule C drugs (Radiopharmaceuticals)​
Division 4 – Schedule D drugs (Biologics)​
Division 5 – Drugs for human Clinical Trials​
Division 6 – Canadian Standard Drugs​
Division 7 – Programs for access to low cost patented medicines​
Division 8 – New drugs (modern definition of drug)​
Division 9 – Non-prescription drug regulations

34
Q

Division 4 Schedule D drugs (biologics)

A

Allergenic substances used for the treatment or diagnosis of allergic or immunological diseases​
Anterior pituitary extracts​
Aprotinin​
Cholecystokinin​
Drugs obtained by recombinant DNA procedures​
Drugs, other than antibiotics, prepared from micro-organisms

Drugs that are or are made from blood​
Glucagon​
Gonadotrophins​
Immunizing agents​
Insulin
Interferon

Monoclonal antibodies, their conjugates and derivatives​
Secretin​
Snake Venom​
Urokinase

35
Q
A

General - C.04.001 to .049​
- Segregation of work with spore formers and infectious agents​
- Submission of protocols and samples​
- Animal use​

Bacterial Vaccines - C.04.050 to .085​
- General, Typhoid, Pertussis, BCG​

Viral Vaccines - C.04.100 to .136​
- General, Rickettsial, Small pox, Polio​

Toxins, Toxoids, Antisera - C.04.140 to .229​
- Diphtheria, Tetanus​

Human Plasma Collected by Plasmapheresis - C.04.400 to .428

Insulin Preparations - C.04.550 to .656

Anterior Pituitary Extracts - C.04.675

36
Q

Complexity of therapeutic products

A

Acetaminophen
Insulin
Cell Product

37
Q

Definitions

A

Therapeutic product: means a drug or device or any combination of drugs and devices, but does not include a natural health product within the meaning of the Natural Health Products Regulations;

Drug: includes any substance or mixture of substances manufactured, sold or represented for use in​

(a) the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in human beings or animals,​

(b) restoring, correcting or modifying organic functions in human beings or animals, or​

(c) disinfection in premises in which food is manufactured, prepared or kept;  ​

Device: Health or medical instrument used in the treatment, mitigation, diagnosis or prevention of a disease or abnormal physical condition. (abbrev.)​

Biologic: A drug product derived from a living organism (animal, plant or microbe)​
- Blood, blood products, cells, tissues, organs, including xenografts (living cells, tissues and organs from animal sources), gene therapies, viral and bacterial vaccines, therapeutic products produced through biotechnology, and radiopharmaceuticals​

Natural Health Product: A finished health product derived from nature (biologic or food) (adapted)​
- Vitamins and minerals, herbal remedies, homeopathic medicines, traditional medicines such as traditional Chinese medicines, probiotics, amino acids, and essential fatty acids (all non-prescription; have their own regulations)

38
Q

Biologics versus Conventional Pharmaceuticals 1/4

A

Raw materials used for biologics are variable in nature​
- Eg. serum derivatives, enzymes, cell substrates​

Manufacturing processes are biological in nature and variable​
- Eg. prokaryotic or eukaryotic cell systems​

Biologics are highly susceptible to microbial growth (biologic: mixture of protein or polysaccharides) ​
- Microbial contamination must be considered at every step during the manufacture of a biologic.

39
Q

Biologics versus Conventional Pharmaceuticals 2/4

A

Heat sensitive (heat labile); most are stored continuously at 2 to 8 0C, some are not only stored cold or frozen but are shipped in a frozen state e.g. live polio vaccine. ​
- manufacturing process may require temperatures below 10 0C depending on the nature of the product being manufactured and the length of time required to complete the manufacturing process.​

40
Q

Biologics versus Conventional Pharmaceuticals 3/4

A

The stages of manufacture are often carried out under conditions that cannot meet the same standards as conventional pharmaceuticals​
- no terminal sterilization​
- aseptic processing​

Test methods needed to characterize batches of the product are variable in nature​
- potency, purity and safety of most biologics can not be adequately tested by chemical or physical means alone​
- bioassays have a high degree of variability/invalidity​

​

41
Q

Biologics versus Conventional Pharmaceuticals 4/4

A

Complex structure of final product​
-molecular weight and structure undefined​
-composition undefined (vaccines)​

A system of in-process controls required for biologic production​

Quality can not be established entirely by tests on the final product​

  • “Quality is built into a product and not just tested into a finished product.”​

+Consistency in

+ production/product​
Absence of Contamination

FED drug class (10 decks)

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