Chapter 9 - Introduction to Pharmaceutical R & D Flashcards
What is the average cost of bringing a new drug to market?
$1.5 to $1.8 billion.
How long is a drug usually in clinical trials?
6-7 years.
How do lengthening development times dramatically increase the cost of bringing a new drug to market?
It increases the cost of capital.
How many compounds that enter R&D are approved by the FDA as a new medicine?
Only 1 out of every 5,000-10,000.
Only 2 of 10 marketed drugs produce revenue that matches or exceeds R&D costs. True or false?
True.
What are the reasons pharmaceutical R&D has become longer and more complex?
- More complex scientific tools and disease targets.
- A more intensive regulatory process.
- Growing demand in the medical community for more complex data about pharmaceuticals.
What percentage of R&D costs are estimated to have been spent on Phase III clinical trials?
90%.
Which arm of the Department of Health and Human Services investigates regulatory infractions, provides compliance advice, and brings enforcement actions?
Office of the Inspector General (OIG)
PhRMA
Pharmaceutical Research and Manufacturers of America - One of the most powerful and influential regulatory bodies in the U.S pharmaceutical industry.
FDA Modernization Act of 1997
Major step forward in enabling safe and effective new drugs and biologics to made available sooner to patients.
What is the best way to deliver healthcare and why?
A market-based system because it promotes innovation, competition, and the highest quality of patient care in a cost-effective manner.
What was the intent of the Bayh-Doyle Act and the Stevenson-Wydler Technology Innovation Act?
To hasten the commercialization of technologies that otherwise might never have been used.
What did the G10 Medicines Group recently report about the pharmaceutical industry in the EU?
There is poor collaboration between public and privately funded research centers.
Pharmaceutical companies spend more on R&D than on DTC advertising and other types of promotion. True or false?
True.
How much of total marketing expenses went to providing free samples to doctors for distribution to patients, many of whom might not otherwise be able to afford it?
More than half.
What does pharmacogenetics focus on?
Differences in drug effects due to slight genetic differences in patients that can affect how an individual metabolizes medicines.
A branch of the FDA that exercises control over whether prescription drugs and OTC drugs may be used for therapy.
The Center for Drug Evaluation and Research (CDER)
A branch of the FDA that regulates the use of biologics, including serums, vaccines, and blood products.
The Center for Biologics Evaluation and Research (CBER)
This act authorized the FDA to acquire information about patients taking vaccines, to recall biologics, and to recommend civil penalties if guidelines regarding biologics were not followed.
1986 Childhood Vaccine Act
What is the average NDA review time for new drugs?
17-24 months
The European version of the FDA, that establishes the baseline standard to which pharmaceutical companies must adhere.
European Medicines Agency
Provides ethical guidelines to physicians about appropriate interactions with pharmaceutical companies.
American Medical Association
Generally, how long does it take for a new drug to be developed (from discovery to FDA approval)?
10-15 years
How would increased pharmaceutical price controls affect the US healthcare system?
Increased price controls would stifle innovation.
