Exam 2: Regulatory History and Laws

Question 1

How did Mrs. Winslow’s Soothing Syrup impact the regulatory oversight of drugs in the USA?

Answer 1

It was unlabeled and laced with morphine and killed many infants

Question 2

How did mariana wine impact the regulatory oversight of drugs in the USA?

Answer 2

Had extract of cocaine and recommended for depression

Termed nonharmful

Question 3

How did Upton Sinclair’s book “The Jungle” impact the regulatory oversight of drugs in the USA?

Answer 3

“I aimed at the public’s heart, and by accident I hit it in the stomach”

Influenced the Pure Food and Drug Act of 1906

Question 4

How did marketing a liquid sulfonamide preparation in 1937 by the Massengil Drug Company impact the regulatory oversight of drugs in the USA?

Answer 4

Wanted liquid sulfonamide preparation so they dissolved sulfanilamide in ethylene glycol
107 deaths from renal failure
Prosecuted for “misbranding”
Led to Food, Drug, and Cosmetic Act of 1938

Question 5

How did adverse event reporting regarding chloramphenicol by the Parke-Davis drug company during the 1950s impact the regulatory oversight of drugs in the USA?

Answer 5

The company knew of the drug’s propensity to cause blood dyscrasias but they minimized or ignored the problem
Continued to recommend use of chloramphenicol in situations where more benign drugs would have worked
3.5 m doses prescribed; several 100 deaths occurred

Question 6

What is the significance of the Food, Drug, and Cosmetic Act of 1938 relative to regulatory oversight of therapeutics?

Answer 6

Required that a drug be safe
Efficacy did not have to be proven
Major loophole: company was not mandated to share information and could conceal problems
FDA could not routinely inspect records or facilities

Question 7

What is the significance of the Kefauver-Harris amendment to the Food, Drug, and Cosmetic Act, 1962 relative to regulatory oversight of therapeutics?

Answer 7

Required drug to be both safe and effective
Require post-market surveillance
FDA must approve package labeling
FDA given broader inspection privileges
More stringent constraints (Good Manufacturing Practices- GMP)

Question 8

What is the significance of the Durham-Humphrey Amendment, 1951 relative to regulatory oversight of therapeutics?

Answer 8

Separated OTC vs. legend drugs (required a prescription)

Exemption for veterinary drugs

Question 9

What is the significance of the Food Additive Amendment, 1958 relative to regulatory oversight of therapeutics?

Answer 9

Created because of cobalt salts added to beer to maintain foam, which led to cobalt toxicity and cardiomyopathy in a heavy drinker
Food additives must be safe

Question 10

What is the significance of the Delaney Clause of the Food Additive Amendment relative to regulatory oversight of therapeutics?

Answer 10

Set zero tolerance for a carcinogen in food
Repealed in 1996 for nondrugs (pesticides); “Reasonable certainty of no harm” replaces zero-risk as the new safety standard

Question 11

What is the significance of The Controlled Substances Act (CSA) of 1970 relative to regulatory oversight of therapeutics?

Answer 11

Establishes Drug Enforcement Administration (DEA) for dealing with drugs of abuse
Creates “schedules” or categories of drugs based on their medical utility versus their risk of abuse
Different record requirements for each schedule of drug
Require medical/vet practitioner to obtain federal DEA license separate from their state license to obtain, use, dispense, or prescribe controlled drugs

Question 12

What is the significance of The Generic Animal Drug & Patent Term Restoration Act (GADPTRA) of 1988 relative to regulatory oversight of therapeutics?

Answer 12

Provides patent extension to compensate for regulatory approval process
Adds ½ of time from beginning of phase 1 trials to approval and time from final submission to approval, up to 5 years
Allows for generic drug manufacturing

Question 13

What is the significance of The Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA) relative to regulatory oversight of therapeutics?

Answer 13

Allows for the extra-label drug use of drugs by veterinarians if certain conditions are met
Of major importance to food animal vets

Question 14

What is the significance of The Animal Drug Availability Act of 1996 relative to regulatory oversight of therapeutics?

Answer 14

Intended to increase number of new animal drugs

Established the veterinary feed directive

Question 15

What is the significance of “The Medically Important Antimicrobials Guidance for Industry document #152” of 2003 relative to regulatory oversight of therapeutics?

Answer 15

Evaluating the safety of antimicrobial new animal drugs with regard to their microbiological effects on bacteria of human health concern

Question 16

What is the significance of The Minor Use/Minor Species Act (MUMS) of 2004 relative to regulatory oversight of therapeutics?

Answer 16

Added incentives for drug companies to develop drugs to be used in either:
Major use in a minor species
Minor use in a major species

Question 17

What is the significance of The Animal Drug User Fee Act (ADUFA) and the Animal Generic Drug User Fee Act (AGDUFA) of 2008 relative to regulatory oversight of therapeutics?

Answer 17

Set up user fees by drug companies to hire staff and provide resources to decrease time for the drug approval process

Question 18

What is the significance of Veterinary Medicine Mobility Act of 2014 relative to regulatory oversight of therapeutics?

Answer 18

Amended the Controlled Substances Act to allow a veterinarian with a valid DEA registration to transport and dispense controlled substances at a site other than such vet’s principal place of practice, as long as the distant site is located in a state where the vet is licensed to practice

Question 19

What is the significance of Veterinary Feed Directive (VFD) Amendment of 2015 relative to regulatory oversight of therapeutics?

Answer 19

Went into full effect January 2017
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 through VFDs
Part of FDA’s “judicious use” strategy to combat antimicrobial resistance

Question 20

What is the significance of Virus-Serum-Toxin Act of 1913 relative to regulatory oversight of therapeutics?

Answer 20

Initially created due to significant losses from unregulated manufacture and distribution of anti-hog cholera antiserum
Gives the USDA regulatory control over vaccines, biologics, and patient-side diagnostics for animals

Question 21

What is the significance of The Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), 1947 / rewritten 1972 relative to regulatory oversight of therapeutics?

Answer 21

Provides for federal regulation of pesticide distribution, sale, and use
Concerns about long and short term toxic effects of pesticide exposure led to a complete revision of FIFRA in 1972
—This completely replaced the original 1947 law and is the basis of current federal oversight