Approved and Unapproved Drugs

Question 1

Regulatory Agencies:

FDA

Answer 1

Pharmaceuticals, nutraceuticals, food

Controlled Substances

Question 2

Regulatory Agencies:

DEA

Answer 2

Controlled substances

Question 3

Regulatory Agencies:

USDA

Answer 3

Biologics (Vaccines)

Question 4

Regulatory Agencies:

EPA

Answer 4

Pesticides

Question 5

Drug

Answer 5

An article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.

An article intended to affect the sturcture or function of the body other than fodd.

If a substance affects the structure or function of the body apart from its nutritive value it may be considered a drug

Question 6

Approved Drug

Answer 6

Species,

Indication

Dose, route and duration

Question 7

Extralabel Drug Use

Answer 7

Does not meet a single criteria for Approved drug

Change species

Change indication

Change dose

Change route

Question 8

Unapproved Drug

Answer 8

A drug/chemical/extract or food intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease

An article intended to affect the structure or function of the body other than nutritive value of food that is not an apporved drug

Extralabel use of an approved drug

Extralabel use of a drug only approved for use in humans

Question 9

Supplememts

Answer 9

Dietary supplement and Health Education Act (DSHEA) of 1994, has affected the way FDA regulates “food for humans” it restricts substances from being food additives or drugs if the product meets the definition of a dietary supplement

There are no “Dietary Supplements” in animal medicine, it is either foood or “new animal drugs”

Question 10

Supplement Standards

Answer 10

• No pre-approval testing required
  
  • No safety studies are required
  • No efficacy studies are required
• Good Manufacturing Practices are not required
  
  • Potency, purity, consistency, stability not required
• FDA is regulatory agency for post marketing surveillance, including adverse effects or tainted products
• Please report adverse effects, including lack of effect, to FDA for all products regardless

Question 11

Pioneer Drug

Answer 11

• The original approval for a chemical entity
  
  • NADA - new animla drug application
  • Company owns exclusive marketing rights for a period of time and can exclusively market the drug
• Company Must Demonstrate:
  
  • Safety
    
    • Target animal
    • Food Supply
      
      • drug residues in edible tissue
      • Bacterial resistance
    • Environment
    • User
  • Efficacy - substantial evidence in 1 or more controlled clinical trials
  • Manufacturing Processes
    
    • Chemistry, manufacturing and conctrols

Question 12

Safety Studies

Answer 12

FDA currently requires a minimum of administering a placebo/vehicle and 1x, 3x, and 5x, the highest labeled dose for 3 times the duration of treatment for up to 90 days

Question 13

Drug Approval

Answer 13

• Generic (Bioequivalent) drug
  
  • after the exclusivity and patents expire, generic formulations of the drung can be approved with bioequivalence studies
  • ANADA abbreviated new aniaml drug application
  • Bioequivalence studies typically are pharmacokinetic studies with AUC and CMAX being the pivotal parameters assessed
  • The assumption is that the efficacy and safety will be similar if the AUC and CMAX are similar
  • Still need FDA inspected manufacturing procedures