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 or 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, and 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 are the Bayh-Doyle Act and the Stevenson-Wydler Technology Innovation Act?
Laws that hastened 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?
The science base is fragmented by relatively weak links between member states’ research centers and poor collaboration between public and privately funded research.
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.
