Chapter 9 | Introduction to Pharmaceutical R&D

Question 1

Cost of bringing one new drug to market

Answer 1

$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

Question 1

It takes 10-15 years to develop a new drug from the laboratory to approval by the FDA

Answer 1

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

Question 2

In 2012, the FDA approved 39 new medicines

Answer 2

True

the highest number in 16 years

Question 3

For every 5,000-10,000 compounds that enter R&D, only 1 is approved by the FDA as new medicine

Answer 3

True

Question 4

Only 2 of 10 marketed drugs produced revenue that match or exceed R&D costs

Answer 4

True

Question 5

Experts have estimated that ____% of the costs associated with new drug development are spent on Phase III trials

Answer 5

90%

Question 6

There are over 5,400 new drugs currently in development

Answer 6

True

Question 7

Which area of drug R&D has seen the largest cost increases?

Answer 7

clinical trials

Question 8

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)?

Answer 8

10-15 years

Question 9

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

Answer 9

PhRMA

Question 10

Growing demand in the medical community for more complex data about pharmaceuticals has simplified the pharmaceutical R&D process?

Answer 10

False

Question 11

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.

Answer 11

True

Question 12

Which type system is the best way to deliver healthcare?

Answer 12

a market-based system

Question 13

How would increased pharmaceutical price controls affect the U.S. healthcare system?

Answer 13

Increased price controls would stifle innovation.

Question 14

Which invests a greater percentage of sales in research than the biotech sector
a) aerospace
b) communications
c) electronics
d) none of the above

Answer 14

d) none of the above

Question 15

What was the intent of the Bayh-Dole Act and the Stevenson-Wydler Technology Innovation Act?

Answer 15

To hasten the commercialization of technologies that otherwise might not be used.

Question 16

What did the G10 Medicines Group recently report about the pharmaceutical industry in the European Union (EU)?

Answer 16

There is poor collaboration between publicly- and privately-funded research centers.

Question 17

USP is the first comprehensive publication of drug standards

Answer 17

U.S. Pharmacopoeia

established in 1820

Question 18

U.S. Pharmacopoeia

Answer 18

A medical reference summarizing standards of drug purity, strength and directions for synthesis.

Question 19

US Pharmacopoeia and the National Formulary (NF) was established by the APhA (American Pharmamceutical Association)

Answer 19

True

Drug products covered by USP
Pharmaceutical ingredients covered by NF

Question 20

in 1902, the Biologics Control Act helped

Answer 20

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

Question 21

What gave the government power to control the labeling of medicines

Answer 21

The Pure Food and Drug Act of 1906

Question 22

The Sherley Amendment prohibited the sale of drugs labeled with false therapeutic claims that were intended to defraud the consumer

Answer 22

True

Question 23

In 1938, Congress passed the Food, Drug, and Cosmetic Act, which was

Answer 23

the first law preventing the sale of drugs that had not been thoroughly tested before marketing.

Question 24

Dietary Supplement Health and Education Act of 1994

Answer 24

to control misleading industry claims

Question 25

In 1988, the Food and Drug Administration (FDA) was officially established as an agency of the US Department of Health and Human Services

Answer 25

True

Question 26

CDER: Center for Drug Evaluation and Research

Answer 26

a branch of the FDA that exercises control over whether prescription drugs and OTC drugs may be used for therapy

Question 27

CBER: Center for Biologics Evaluation and Research

Answer 27

a branch of the FDA that regulates the use of biologics including serums, vaccines, and blood products

Question 28

The phases of approval for therapeutic and biologic drugs

Answer 28

1. preclinical investigation
2. clinical investigation
3. review of the New Drug Application (NDA)
4. post-marketing surveillance

Question 29

The FDAs Critical Path Initiative was an effort to

Answer 29

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.

Question 30

Clinical phase trials are the longest part of the drug approval process

Answer 30

True

Question 31

Clinical investigation, the second phase of drug testing, takes place in three different stages termed clinical phase trials

Answer 31

True

Question 32

A New Drug Application must be submitted before a drug is allowed to proceed to the next phase of the approval process.

Answer 32

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.

Question 33

By law, the FDA is permitted 6 months to initially review an NDA

Answer 33

True

The NDA review is the their phase of the drug approval process; during this phase, the drug’s brand name is finalized

Question 34

The average NDA review time for new drugs

Answer 34

approximately 17-24 months

Question 35

Post-marketing surveillance

Answer 35

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

Question 36

Reasons identified for the delay in the FDA drug approval process

Answer 36

-outdated guidelines
-poor communication
-insufficient staff to handle the workload

Question 37

Pharmaceutical regulations are designed to protect the public welfare and ensure that critical new therapies reach the market quickly and safely

Answer 37

True

Question 38

The following public policy initiatives are vital to the support of pharmaceutical innovation

Answer 38

-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

Question 39

The pharmaceutical industry is the most research-intensive industry in the United States and invests far more than its international competitors

Answer 39

True

Question 40

Reasons US R&D investments has increased

Answer 40

-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