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.
Dietary Supplement Health and Education Act of 1994
to control misleading industry claims
In 1988, the Food and Drug Administration (FDA) was officially established as an agency of the US Department of Health and Human Services
True
CDER: Center for Drug Evaluation and Research
a branch of the FDA that exercises control over whether prescription drugs and OTC drugs may be used for therapy
CBER: Center for Biologics Evaluation and Research
a branch of the FDA that regulates the use of biologics including serums, vaccines, and blood products
The phases of approval for therapeutic and biologic drugs
- preclinical investigation
- clinical investigation
- review of the New Drug Application (NDA)
- post-marketing surveillance
The FDAs Critical Path Initiative was an effort to
modernize the sciences to enhance the use of bio-information to improve “safety, effectiveness, and manufacturability of candidate medical products.”
Listed areas of improvement were the fields of genomics and pro-teonomics, imaging, and bioinformatics.
Clinical phase trials are the longest part of the drug approval process
True
Clinical investigation, the second phase of drug testing, takes place in three different stages termed clinical phase trials
True
A New Drug Application must be submitted before a drug is allowed to proceed to the next phase of the approval process.
True
An Investigational New Drug Application (IND) may be submitted for Phase I clinical trials when it is determined that there are significant therapeutic benefits, and that the product is reasonable safe for initial use in humans.
Companies usually begin developing a brand name for drugs during Phase I of the IND process.
By law, the FDA is permitted 6 months to initially review an NDA
True
The NDA review is the their phase of the drug approval process; during this phase, the drug’s brand name is finalized
The average NDA review time for new drugs
approximately 17-24 months
Post-marketing surveillance
the final phase of the drug approval process (begins after clinical trials and the NDA review have been completed)
the purpose: to survey for harmful drug effects in a larger population
Reasons identified for the delay in the FDA drug approval process
-outdated guidelines
-poor communication
-insufficient staff to handle the workload
Pharmaceutical regulations are designed to protect the public welfare and ensure that critical new therapies reach the market quickly and safely
True
The following public policy initiatives are vital to the support of pharmaceutical innovation
-continued public support for biomedical research
-rigorous, efficient, and transparent regulation of pharmaceuticals
-understanding the value of pharmaceuticals
-avoiding new pharmaceutical price controls
-maintaining the Hatch-Waxman Act balance
The pharmaceutical industry is the most research-intensive industry in the United States and invests far more than its international competitors
True
Reasons US R&D investments has increased
-greater opportunities for innovation because of advances in scientific knowledge and tools
-great R&D investment flowing to the US instead of Europe and Japan, where price control policies have stifled new product development
