Chapter 9 | Introduction to Pharmaceutical R&D Flashcards
Cost of bringing one new drug to market
$140 million in the 1970s
$320 million in the 1980s
$800 million in the late 1990s
$1.2 billion in early 2000s
estimates now: $1.5-$1.8 billion
It takes 10-15 years to develop a new drug from the laboratory to approval by the FDA
True
3-6 years spent in pre-discovery and pre-clinical trials
6-7 years spent in clinical trials
FDA approval can take another .5-2 years
In 2012, the FDA approved 39 new medicines
True
the highest number in 16 years
For every 5,000-10,000 compounds that enter R&D, only 1 is approved by the FDA as new medicine
True
Only 2 of 10 marketed drugs produced revenue that match or exceed R&D costs
True
Experts have estimated that ____% of the costs associated with new drug development are spent on Phase III trials
90%
There are over 5,400 new drugs currently in development
True
Which area of drug R&D has seen the largest cost increases?
clinical trials
On average, how long does it take for a new drug to be developed (i.e. from the discovery of the initial compound to FDA approval)?
10-15 years
Which of the following agencies is industry-based (i.e. run mainly by the companies themselves)?
a) Drug Enforcement Administration
b) European Medicines Agency
c) Pharmaceutical Research and Manufacturers of America (PhRMA)
d) FDA
PhRMA
Growing demand in the medical community for more complex data about pharmaceuticals has simplified the pharmaceutical R&D process?
False
The landmark FDA Modernization Act of 1997 was a major step forward in enabling safe and effective new drugs and biologics to be made available sooner to patients.
True
Which type system is the best way to deliver healthcare?
a market-based system
How would increased pharmaceutical price controls affect the U.S. healthcare system?
Increased price controls would stifle innovation.
Which invests a greater percentage of sales in research than the biotech sector
a) aerospace
b) communications
c) electronics
d) none of the above
d) none of the above
What was the intent of the Bayh-Dole Act and the Stevenson-Wydler Technology Innovation Act?
To hasten the commercialization of technologies that otherwise might not be used.
What did the G10 Medicines Group recently report about the pharmaceutical industry in the European Union (EU)?
There is poor collaboration between publicly- and privately-funded research centers.
USP is the first comprehensive publication of drug standards
U.S. Pharmacopoeia
established in 1820
U.S. Pharmacopoeia
A medical reference summarizing standards of drug purity, strength and directions for synthesis.
US Pharmacopoeia and the National Formulary (NF) was established by the APhA (American Pharmamceutical Association)
True
Drug products covered by USP
Pharmaceutical ingredients covered by NF
in 1902, the Biologics Control Act helped
standardize the quality of serums and other blood related products.
In the early 1900s, the US began to develop and enforce tougher drug legislation to protect the public
What gave the government power to control the labeling of medicines
The Pure Food and Drug Act of 1906
The Sherley Amendment prohibited the sale of drugs labeled with false therapeutic claims that were intended to defraud the consumer
True
In 1938, Congress passed the Food, Drug, and Cosmetic Act, which was
the first law preventing the sale of drugs that had not been thoroughly tested before marketing.
