Exam 2: Approved and Unapproved Drugs

Question 1

What does the FDA have jurisdiction over?

Answer 1

Drugs
Nutraceuticals
Therapeutic diets

Question 2

What does the USDA have jurisdiction over?

Answer 2

Diagnostic tests
Vaccines
Antiserum
Monoclonal antibody treatments
Normal plasma

Question 3

What does the EPA have jurisdiction over?

Answer 3

Rodenticides

Insecticides

Question 4

Explain what a VFD medicated feed is and how it contrasts to other medicated feeds

Answer 4

VFD is a veterinary feed directive that requires authorization by a veterinarian
Some VFDs can be made by both licensed and unlicensed feed mills

Question 5

Explain the implications of the 2015 amendment to the VFD regulations as it relates to over the counter antimicrobial use

Answer 5

Eliminates the use of medically important antimicrobials for growth promotion and feed efficiency
Brings therapeutic use in feed and water under the supervision of vets

Question 6

Briefly explain the generic drug approval process

Answer 6

Copy an already approved new animal drug
Same active ingredient, strength, dosage, ROA
Bioequivalent to pioneer product do so via pharmacokinetics
Not safety and effectiveness!

Question 7

Contrast OTC versus VFD as they relate to medicated animal feeds

Answer 7

OTCs are all medicated feed other than VFD. Only antibiotics with no human health implications will remain OTC
VFDs require authorization by a vet

Question 8

Contrast category 1 versus category 2 as they relate to medicated feeds

Answer 8

Category 1: Animal drugs which require no withdrawal period
—Can be made by both licensed and unlicensed feed mills
Category 2: Animal drugs which require a withdrawal period, and/or have a zero-tolerance residue limit
—Made only by licensed feed mills

Question 9

Contrast type A, B, and C medicated feeds

Answer 9

Type A: a basic raw medicated article and carrier that is used in manufacturing medicated feeds
Type B: an animal remedy containing animal feed produced from a Type A drug. Can be used to make other Type B or Type C feeds
Type C: Contain an animal drug and may be offered as complete feed, either free-choice or top-dressed on another feed

Question 10

By what means may an unapproved veterinary drug be legally marketed in the USA?

Answer 10

Conditional approval
Designation
Indexing

Question 11

What is conditional approval?

Answer 11

Allows to make the drug available before collecting all necessary effectiveness data, but after proving the drug is safe
The sponsor can keep the product on the market for up to 5 years, through annual renewals, while collecting effectiveness data

Question 12

What is designation?

Answer 12

Similar to “Orphan Drug Act” for humans
Provides incentives for approval
Grants to support safety and effectiveness testing will be available
Company given 7 years of marketing exclusivity

Question 13

What is indexing?

Answer 13

When the potential market for minor species drug is just too small to ever support the costs of the drug approval process, even under a conditional approval
The drug can be indexed, which allows it to be a legally marketed unapproved new animal drug

Question 14

Describe the supporting evidence and regulatory oversight for nutraceuticals

Answer 14

Regulated by the FDA. Due to limited resources, however, the FDA uses “enforcement discretion” and does not approve efficacy or assure safety beyond that of a food stuff
The company does NOT have to prove efficacy in order to market the product

Question 15

Describe the supporting evidence and regulatory oversight for therapeutic diets

Answer 15

Regulated by the FDA. Due to limited resources, however, the FDA uses
“enforcement discretion” and does not approve efficacy or assure safety beyond that of a food stuff
The company does NOT have to prove efficacy in order to market the product

Question 16

Describe the supporting evidence and regulatory oversight for holistic medications

Answer 16

Regulated as drugs under the FDA, but the FDA does not evaluate the meds for safety or effectiveness

Question 17

Describe the supporting evidence and regulatory oversight for homeopathic medications

Answer 17

Regulated as drugs under the FDA, but the FDA does not evaluate the meds for safety or effectiveness

Question 18

What effect does the Veterinary Feed Directive (VFD) Amendment of 2015 have on the use of antimicrobials in medicated feeds relative to claims for growth promotion, feed efficiency, disease prevention, and disease control?

Answer 18

Eliminates the use of medically important antimicrobials for growth and feed efficiency
Disease prevention and control are still allowed