Chapter 3 - Strength for the U.S. Economy Flashcards
What must a drug be in order to afford sufficient protection from a patent from imitators?
It must be novel.
Once a drug’s patent expires, other companies are free to market drugs with the same active ingredients and efficacies. What are drugs called?
Generics.
What are the three functional categories that exist within a pharmaceutical company?
Research & development (R&D), manufacturing and operations, and marketing & sales.
What is one of the most significant results of the pharmaceutical industry’s continued investment in R&D?
The large number of new drugs approved and in development.
How many drugs are expected to be approved every year internationally?
Over 100.
Of the 5,000 medicines that are currently in development, how many are in the U.S.?
3,400.
How long is someone diagnosed with AIDS expected to live if recommended therapy guidelines are followed?
50 years.
How many people are directly employed by the pharmaceutical industry?
650,000 people.
How much in net economic gains has increased life span created for Americans?
$2.4 trillion (more than 20% or the gross domestic product).
What is the key reason for the transfer of R&D investment from Europe to the U.S.?
Differences in national price control policies.
What negative impact have price controls and cost containment programs had on R&D in several countries?
Pharmaceutical industries have weakened or have shifted outside their borders.
Asymptomatic
Without signs or symptoms of disease.
Blinded (masked) study
Study in which participants do not know whether they are in the experimental or control group in a research study.
Control group
The standard by which experimental observations are evaluated.
Double-blinded study
Neither the participants nor the study staff know which participants are receiving the experimental treatment and which patients are in the control group.
Edema
Swelling
Fast-track drugs
Drugs that meet medical needs for patients with serious or life-threatening conditions.
Indication
In terms of drug approval, the exact purpose for which the FDA has approved that a drug can be described.
Institutional Review Board (IRB)
Committee of physicians, statisticians, community advocates, and others which ensures that the clinical trial is ethical and that the rights of the participants are protected.
Off label
Usage of a medication for purposes other than the specific ones appearing in the labeling.
Placebo
An inactive pill, liquid, or powder that has no treatment value.
Placebo effect
The effect produced by a placebo due to the expectations of the patient.
Study protocol
General design and operating features of a clinical trial.
Toxicity
The extent, quality, or degree to which a substance is poisonous or harmful to the body.
Treatment group
A group of patients assigned to receive a specified treatment.
