The FDA In The Age Of Genome Based Medicine
February 2, 2001
Over the past 20 years, the Food and Drug Administration reinvented itself several times -- with programs to speed up drug development, paperless applications and user fees to help fund the agency. But the time involved in developing new drugs has stayed about the same, while the costs have risen in excess of inflation.
- Only one out of every 50,000 drugs initially screened actually becomes a new medicine.
- The timeline involved in bringing a new drug to market remains at about a decade.
- The cost of doing so has jumped from $200 million per new drug in 1980 to about $500 million today.
Experts warn that the problems will only get worse as pharmaceutical companies attempt to exploit the benefits of modern biology -- including the great promise of the human genome project. They say the sequencing of the human genome has given medicine a vastly better understanding of individuality and made it possible to custom-tailor medicines for individual human beings.
But critics say the FDA is standing in the way of utilizing scientific breakthroughs. It will need to develop systems that will bring individualized therapies through its regulatory maze in a timely and less expensive manner.
Sources: Robert Oldham (South Carolina Biotechnology Association), "Cracking the FDA Code," and Editorial, "A 21st Century FDA," both in the Wall Street Journal, February 2, 2001.
For WSJ text
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