Actually you numbers are ok for history, but do not take into account recent changes. Some news extracts below demonstrate the significant improvements being achieved in the FDA process time and cost.
In the CYGS case they have declared the strategy of proceeding through partners with antisense molecules so would not directly bear this cost themselves.
Graham
Under direction of Commissioner David Kessler, MD, and with the support of the
Clinton administration, the FDA has made a significant effort to improve its
performance, and it has the numbers to prove it. Dr. Kessler has produced
figures showing that the FDA has cut approval times, and he makes a good
case that this country does not trail the world in medical technology, as FDA
critics say....JAMA 96
Among the most significant parts of the FDA reform bill is a reauthorization of the Prescription Drug User Fee Act (PDUFA), which enlists user fees from drug manufacturers to facilitate hiring more inspectors and speed the approval process. Since its enactment in 1992, PDUFA has enabled the FDA to hire 600 more reviewers and cut review time for drugs nearly in half. The FDA reform bill streamlines drug development by allowing electronic submissions instead of what was often carloads of paper, and it updates the
approval process for biotech companies...US Senate 1997
Updating the approval process for biotechnology products is another critical component of FDA reform. The biotechnology field is one of the fastest growing industries in our country. In my state of Maryland, there are 143 biotech companies. Biotechnology medicines are being developed to treat conditions like AIDS, Alzheimer's disease, breast and ovarian cancers, and life-threatening infections such as
whooping cough. These small entrepreneurial, start-up companies are on the cutting edge of scientific research. They can literally live or die based on FDA approval of their products.
This bill updates and streamlines the biotech approval process. It puts into law several of Vice President Gore's reinventing government initiatives that take into account the unique nature of biotech products. The bill does away with outdated, duplicative requirements for biologics. ....US Senate 1997 |
