Deck 21: Prescription Drugs: How a Pill Becomes the Law

Question 1

Which statement is accurate regarding Medicare Part D?

A)It prevents Medicare from using its negotiating power as the world's largest purchaser of drugs to obtain discounts from drug companies.
B)It encourages reimporting domestically produced drugs from foreign countries where prices are significantly lower.
C)It encourages utilization of patent reform to lower costs to consumers.
D)It relies on Medicare using its negotiating power as the world's largest purchaser of drugs to obtain discounts from drug companies.

Answer 1

It prevents Medicare from using its negotiating power as the world's largest purchaser of drugs to obtain discounts from drug companies.

Question 2

In response to the Elixir Sulfanilamide tragedy, the FDA ____.

A)imposed a fine against Massengill for mislabeling the product as an elixir, as it contained no alcohol
B)sought initiation of a criminal proceeding against the head of Massengill
C)brought a civil action imposing substantial civil penalties against Massengill
D)relied on private whistleblowers to file suit against Massengill

Answer 2

imposed a fine against Massengill for mislabeling the product as an elixir, as it contained no alcohol

Question 3

In 1992, the Prescription Drug User Fee Act (PDUFA)was passed so that the FDA could ____.

A)fund additional resources and scientists to expedite the drug review process
B)pay for the provision of unapproved drugs to persons with life-threatening illnesses
C)benefit from drug companies' extensive advertising revenues
D)provide additional oversight to prevent the falsification of data

Answer 3

fund additional resources and scientists to expedite the drug review process

Question 4

The federal government's march-in authority, pursuant to the Bayh-Dole Act , has ____.

A)never been invoked against the drug industry
B)been invoked only with respect to health and safety needs
C)never been invoked with respect to reasonable price
D)been invoked on occasion to bring to market "important new drugs"

Question 5

Which statement is accurate regarding prescription drugs in the United States?

A)The pharmaceutical industry has been among the most consistently profitable sectors in the United States with net profits in the billions.
B)The negotiating power of large federal programs has helped bring down drug prices for vulnerable populations.
C)Increases in prescription drug prices have generally lagged behind increases in the Consumer Price Index.
D)Prescription drugs are not expensive in comparison to the benefits they provide to those who are sick.

Question 6

What effect did the Food and Drug Administration Amendments Act of 2007 (FDAAA)have on direct-to-consumer advertising (DTC)?

A)It created voluntary DTC advertising user fees to fund voluntary FDA review of industry ads.
B)It limited DTC advertising to non-drug-specific educational information only.
C)It required in DTC advertising comprehensive disclosure of risks, side effects, and drug interactions.
D)It created mandatory DTC advertising user fees to fund all FDA review of industry ads.

Question 7

By 1933, regulators in the Food and Drug Administration lamented the inadequacy of the Pure Food and Drug Act to regulate the drug industry. In response, President Franklin Roosevelt ____.

A)remained quiet
B)provided loud public pronouncements in support of stronger regulation
C)wrote articles in the popular press against change in the law
D)offered support to the coalition advocating for reform

Question 8

What is the effective patent life of a drug newly approved by the FDA?

A)several years less than 20 years
B)20 years
C)25 years
D)at least 7 years

Question 9

The Pure Food and Drug Act of 1906 required that ____.

A)any labels applied to drugs be accurate
B)all drugs be labeled
C)all therapeutic claims be accurately described on labels
D)all labels and contents be pre-approved by the Bureau of Chemistry

Question 10

Passage of the Federal Food, Drug, and Cosmetic Act led to many changes in the drug industry including ____.

A)intensive marketing directly to doctors via medical journals and office visits
B)intensive marketing directly to consumers via advertisements in newspapers and magazines
C)scaled down scientific staff to reduce the cost of producing new drugs
D)industry-wide agreement to avoid excessive markups on drugs

Question 11

The Federal Food, Drug, and Cosmetic Act , passed in 1938, required that ____.

A)manufacturers must test all new drugs for safety and report their findings to the FDA prior to marketing
B)the FDA must prove fraudulent intent in its prosecutions against false therapeutic claims
C)compulsory licensing whereby drug patent holders would retain only three years of exclusivity
D)newly developed drugs be labeled with complete information about their contents, side effects, and dosages

Question 12

Passage of the 1906 Pure Food and Drug Act took place ____.

A)shortly after publication of a series of muckraking articles in Collier's magazine
B)after five previous efforts to regulate the makers of proprietary medicines
C)after twenty previous efforts to regulate the makers of proprietary medicines
D)shortly before publication of Upton Sinclair's novel The Jungle

Question 13

What was the response of conservative politicians, such as Richard Nixon, to Senator Kefauver's proposed reform bill in 1961?

A)The bill would trample on individual liberties and contribute to the growth of a national bureaucracy.
B)The bill was an intrusion on doctors' ability to use their own independent medical judgment.
C)The bill's reform of the patent system through compulsory licensing needed to be scaled back.
D)The bill's calls for more complete information and a requirement of efficacy as well as safety were worthy goals.

Question 14

What was the drug company's role in the thalidomide tragedy in the United States?

A)It had distributed the unapproved drug to physicians to be administered to their patients as part of an investigation into the drug's safety.
B)It had marketed an FDA-approved drug that caused significant birth defects to thousands of children.
C)It had taken the drug off the market in the U.S. prior to any negative impact on newborns.
D)It had voluntarily compensated the families of children harmed by the drug's use.

Question 15

In which phase of a clinical drug trial does the drug developer test the drug on between 1,000 and 3,000 volunteers who present with the condition the drug purports to treat, over a period of anywhere from 2 to 10 years?

A)Phase 3
B)Phase 1
C)Phase 2
D)Phase 4