Chapter 3 | Strength for the U.S. Economy Flashcards
What are the three functional categories that exist within a pharmaceutical company?
Research & Development (R&D)
Manufacturing & Operations
Marketing & Sales.
PhRMA reports that over _______ medicines are currently in development
5,000, with 3,400 of these in the U.S.
In 2012, FDA regulators approved ___ new drugs for use in the U.S.
39 (the highest number of approvals since 1996)
The European Medicines Agency expects to approve ___ new drugs in 2014.
54
Internationally, _______ new drugs are expected to be approved every year
100+
Two treatments have been approved for hepatitis C
True
a virus that estimated to affect 180 million people worldwide and ultimately leads to liver cirrhosis, cancer, and death. These new antivirals are only two of 66 other hep C medicines currently in development.
12-50% of biopharmaceutical companies are currently developing personalized medicine
True
125 new treatments for Alzheimer’s disease are in development
True
Alzheimer’s is currently the 6th leading cause of death
According to PhRMA’s 2013, The Biopharmaceutical Pipeline, medicines that merely delay the onset of Alzheimer’s could save $447 billion in 2050.
True
3,070 new medicines are in development for cancer, which the World Health Organization has predicted will cause 13.1 million deaths in 2030.
True
The first drug approved for treating metastatic basal cell carcinoma, the most common form of skin cancer was in 2012.
True
281 new diabetes medicines are in development
True
185 medicines are currently in development for HIV/AIDS
True
The pharmaceutical industry is and has been a major source of innovation in the development not only of new drugs, but also ___________ and ___________.
new manufacturing process and scientific knowledge
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 these drugs called?
Generics
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 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.
Study in which participants do not know whether they are in the experimental or control group in a research study.
Blinded (masked) study
Asymptomatic
Without signs or symptoms of disease.
The standard by which experimental observations are evaluated.
control group
Neither the participants nor the study staff know which participants are receiving the experimental treatment and which patients are in the control group.
double blind study
What is edema?
swelling
Drugs that meet medical needs for patients with serious or life-threatening conditions.
Fast-track drugs
Indication
In terms of drug approval, the exact cause or purpose for which the FDA has approved that a drug can be prescribed.
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.
Institutional Review Board
Usage of a medication for purposes other than the specific ones appearing in the labeling.
Off label
An inactive pill, liquid, or powder that has no treatment value.
Placebo
An inactive pill, liquid, or powder that has no treatment value.
Placebo Effect
General design and operating features of a clinical trial.
Study protocol
The extent, quality, or degree to which a substance is poisonous or harmful to the body.
Toxicity
A group of patients assigned to receive a specified treatment.
Treatment group
How do third-party “payer” organizations influence what medications a patient receives?
By offering reimbursement for only certain medications and by enforcing a list of approved drugs that are paid for by the insurance company and then sending that list to doctors and pharmacists to guide them on which drugs should be prescribed for patients enrolled in that particular plan.
Whose responsibility is it to influence the list of approved drugs that are paid for by insurance companies?
Senior-Level Account Managers
What defines “ethical pharmaceutical companies?”
Research and development of novel drugs to be protected by patent from imitators.
Pharmaceutical companies are generally either (belong to which two categories) _________ or _________.
Research-based or focused on manufacturing generic drugs.
One of the most disappointing results of the pharmaceutical industry’s continued investment in R&D is the few new drugs being approved and in development. True or False?
False
In 2012, FDA approved _____ new drugs for use in the U.S., the highest number of approvals since 1996.
39
In 2012, FDA approved _____ new drugs for use in the U.S., the highest number of approvals since 1996.
True
How long are people newly diagnosed with HIV expected to live?
50 additional years
How much has the average lifespan increased since 1890?
30 years
What is the main difference between a blinded and double-blinded study?
In a double-blinded study, neither the study staff nor the study participants know which subjects are in the experimental group and which are in the control group.
How many new treatments have been approved for Hepatitis C?
2
How many new medications are in development for diabetes?
281
How many drugs are in development for cancer?
3070
Pharmaceutical reps mainly visit pharmacies.
False
The pharmacist may dispense a product other than what the physician prescribed.
True
Which of the following would classify as Payers?
Employers
Patients
Pharmacists
Physicians
Employers
How would you define ethical pharmaceutical companies?
Ones that research and develop novel drugs
Full service pharmaceutical companies are divided into what three categories?
Research & Development:
focus on discovering or inventing promising new chemicals or molecules to transform into pharmaceutical products
Manufacturing & Operations:
supply chain, manufacturing, trade and distribution (produce and package drug products)
Marketing & Sales:
personnel communicate the benefits of the products and create demand for those products (in US, a special Managed Markets group is responsible for outreach to large corporate accounts and managed care organizations)
Approvable letter
Letters sent by FDA to applicant indicating whether the new drug application (NDA) or abbreviated NDA (ANDA) for the product substantially meets the necessary requirements or if changes need to be made
