FDA - History And Evolution Of Drug Regulation Flashcards
What is the non-governmental organization which was tasks to provide state-of-the-art standards for testing the identity and purity of medicines?
A) U.S. Pharmacopeia
B) Philadelphia College of Pharmacy
C) American Medical Association
D) US Bureau of Customs
E) National Institutes of Standard and Technology
A) U.S. Pharmacopeia
Which of the following is least relevant to the Kefauver-Harris Amendments of 1962?
A) Patent medicines with ineffective ingredients
B) A very effective, morning sickness drug for pregnant women
C) Thousands of babies born with deformed limbs in Europe
D) The anti-angiogenic drug, Thalidomide
E) Requirement for safety and efficacy before drug marketing approval
A) Patent medicines with ineffective ingredients
The death from Children’s Tylenol laced with cyanide led to certain requirements for tamper-evident packaging. What is not part of tamper-evident packaging requirement for over-the-counter (OTC) drugs as mandated in the Federal Anti-tampering Act of 1982?
A) Tamper-evident device should be prominently displayed .
B) Device should provide clear and visible evidence if tampering has occurred .
C) Labels should clearly state that adult supervision is required for tampering
D) Tamper-evident device should be identified on label .
E) Tamper-evident package should be distinctive by design
C) Labels should clearly state that adult supervision is required for tampering
What is not true of the Hatch-Waxman Act of 1984?
A) Studies that show comparable bioavailability of the active ingredient in human subjects are required
B) Provided patent holders an extended term of protection from competition in the market place if there is delay in obtaining marketing approval
C) Large and expensive clinical trials, similar to that of branded drug trials, are required for marketing approval of the copycat drugs
D) Generic drugs can be marketed only if the patent of the pioneer drug had expired
E) Encouraged the manufacture and marketing of less expensive copies of branded drugs
C) Large and expensive clinical trials, similar to that of branded drug trials, are required for marketing approval of the copycat drugs
The Prescription Drug Users Fee Act of 1992 was passed mainly to:
A) Force drug manufacturers to pay the FDA for their drug reviews
B) Educate consumers as to the proper use of drugs
C) Encourage the development of less expensive drugs
D) Encourage the development of safer and more effective drugs
E) Shorten the time for new drug review and marketing approval
E) Shorten the time for new drug review and marketing approval
The drug, Vioxx, a widely used drug indicated for arthritis, was withdrawn from the market after it was linked to:
A) Heart problems
B) Suicidal thoughts in young people
C) Schizophrenia
D) Depression
E) Liver dysfunction
A) Heart problems
What is of least relevance to the Drug Quality and Security Act of 2013?
A) Resulted from failure to properly sterilize drugs prior to marketing
B) Implementation of electronic and interoperable system to track certain prescription drugs in the U.S
C) Required registration of companies that mix custom medications from bulk drug suppliers
D) Resulted from outbreak of fungal meningitis due to a contaminated steroid used for back pain
E) Allowed pre-approval access to certain investigational drugs when there are no other effective drugs available for a certain condition
E) Allowed pre-approval access to certain investigational drugs when there are no other effective drugs available for a certain condition
What is the best definition of drug according to the FDA?
A) Drugs are intended for use in the prevention, cure, mitigation, or treatment of disease in man
B) Drugs are for use in the cure, mitigation, treatment, diagnosis, or prevention of disease in man
C) Drugs are intended for use in the cure, mitigation, treatment, or diagnosis of disease in man
D) Drugs are intended for use in the cure and treatment of disease in man
E) Drugs are intended for use in the inspection, cure, mitigation, treatment, or prevention of disease in man
B) Drugs are for use in the cure, mitigation, treatment, diagnosis, or prevention of disease in man
What does not apply to patent medicines?
A) Medical benefits of patent medicines have not been proven to work for all diseases that they claim to treat
B) Patent medicines are also known as snake oil, cure alls, or miracle elixirs
C) Salesmen of patent medicines claim that they cure many ailments from rheumatism and cancer to colicky babies
D) Most patent medicines were ordered and delivered through the postal system
E) Patent medicines are not FDA-approved drugs
D) Most patent medicines were ordered and delivered through the postal system
During the 1840s, US was the dumping ground for counterfeit, contaminated, and poor quality drugs from Europe, leading to people’s distrust of pharmacist and doctors. To ensure the quality, purity, and fitness of drugs that are being brought into the US, which law was passed that authorized the US Customs to inspect those drugs?
A) Drug Importation Act
B) Kefauver-Harris Amendments
C) Drug Quality and Security Act
D) Prescription Drug Marketing Act
E) Hatch-Waxman Act
A) Drug Importation Act
What safety crisis led to the Biologics Control Act of 1902 which required manufacturers of biologics to be licensed and inspected annually?
A) Fungal meningitis from contaminated compounded steroid
B) Children died from smallpox vaccine with incompletely inactivated virus
C) Death from Children’s Tylenol that was laced with cyanide .
D) An investigational, unapproved AIDS drug that seemed very effective
E) Death of children from a tetanus-contaminated antitoxin drug against diphtheria
E) Death of children from a tetanus-contaminated antitoxin drug against diphtheria
Dr. Harvey Wiley’s clinical trials with the poison squad tested the toxic effects of food preservatives and led to the Pure Foods and Drug Act of 1906. What was not true of that particular clinical trial?
A) Carcinogenic, mutagenic, or teratogenic studies were done in animals prior to testing in humans
B) No informed consent forms describing possible bad effects on participants health were signed
C) The trial participants were volunteers, not prison inmates
D) No institutional review board to oversee trial safety
E) There was no untreated control group for comparison against the group that was given the preservatives
A) Carcinogenic, mutagenic, or teratogenic studies were done in animals prior to testing in humans
Harvey Wiley’s clinical trials with the poison squad tested the toxic effects of 7 widely used food preservatives. Which was banned as food preservative under the Pure Food and Drug Act of 1906? For the long exam, you will need to know all preservatives that are now banned and those still in use as food preservative.
A) Boric acid
B) Benzoates
C) Sulphites
D) Potassium nitrate
E) Sodium chloride
A) Boric acid
- those still used in food preservatives = Sulphur dioxide/sulphites and potassium nitrate
The legal term for changes or additions to existing laws are referred to as amendments. Which amendment to the Pure Food and Drug Act banned false therapeutic claims on labels that are intended to defraud users of drugs?
A) Wiley Amendment
B) Sherley Amendment
C) Kefauver-Harris
D) Dodd-Frank Amendment
E) Hatch-Waxman Amendment
B) Sherley Amendment
What does not have much to do with the Federal Food Drugs and Cosmetic Act of 1938?
A) Phenobarbital contamination of an antibiotic formulation
B) A requirement that a new drug be demonstrated as safe prior to marketing approval
C) A requirement for physician’s prescription before a patient can purchase certain drugs
D) Setting tolerances for cocaine, heroine, alcohol and morphine in drugs
E) FDA was given the authority to conduct inspections of drug manufacturing factories
A) Phenobarbital contamination of an antibiotic formulation
