In groups L, G, A, N, and C, which account for 16 (14.7%), 13 (11.9%), 9 (8.2%), 9 (8.2%), and 8 (7.3%) of the
new drugs, respectively, the balance between disease burden and the
new drug introduction has been questioned.
The committee oversees pharmacy policies and procedures and reviews the clinical merits, safety, effectiveness and clinical value of
new drugs as they come to market.
But only one
new drug in the last few years has gone on to the next level to be tested for environmental risks through chronic ecotoxicity tests, according to Florian Zielinski, a chemist at the FDA Center for Drug Evaluation and Research.
Efforts are under way to produce
new drugs, but one of the most efficacious candidates has run into economic and manufacturing obstacles (8.9).
The clinical research (IND) phase--representing the time from beginning of human trials to the
new drug application (NDA) submission that seeks permission to market the drug--is by far the longest portion of the drug development cycle and can last from 2 to 10 years.
Moreover, consumer groups fret that there's inherent pressure when industry provides so much funding--about 18 percent of the agency's total budget last year, and half the budget for
new drug reviews.
Dr Peter Barrett-Lee, a consultant oncologist at Cardiff's Velindre Hospital - and breast cancer expert - said the
new drug was 'very promising.'
According to a 2001 Tufts University study--funded by the industry--it costs an average of $800 million to get a single
new drug to market.
Its products are used by pharmaceutical, biotechnology and medical device companies to create
new drug applications, reports, proposals and technical documentation.
Only a relatively small amount of the presumed $400 billion, however, will actually go for
new drug coverage.
These university researchers obtained the R&D costs of 68 randomly selected
new drugs from a survey of 10 pharmaceutical firms, and used the data to estimate the average pre-tax cost of
new drug development.
In contrast, the FDA through the Pediatric Rule issued in 1998 required mandatory testing and enforcement through FDA refusal to approve a
new drug if a manufacturer did not conduct those studies.