The Root(s) of Drug "Delay-to-Market"
December 7 2007
Andrew Grove (former Intel CEO) and Justin Blum (a reporter for Bloomberg) both lament the sorry state of getting promising new drugs to patients...but from quite different perspectives.
Newsweek interviewed Mr. Grove just prior to a speech he was to give at the annual meeting of the Society for Neuroscience in early November 2007. Mr. Grove contrasts the slow pace of drug development with the "deeply felt conviction that what matters is time to market, or time to money" of semiconductor research.
Mr. Grove goes on to say, "The heart of every high-tech executive has been, get the product into customers' hands and ramp up production. That drive is just not present in pharma; the drive to get sufficient understanding and go for it is missing." He goes on to say "The peer review system in grant making and in academic advancement has the major disadvantage of creating conformity of thoughts and values. It's a modern equivalent of a Middle Ages guild..."
The report to the FDA includes:

"Science forms the basis of all regulatory decisions. Those that do not have adequate scientific support are thus subject to delays, or worse, poor decisions. Therefore, effective regulation requires that the scientific competency within FDA matches or exceeds an applicant’s knowledge." (Page 13)
So, is Mr. Grove right on, or is he perhaps missing an important (approval) point? Getting effective drugs to market isn't an "either-or" issue, but rather a complex mosaic of factors, which includes our world-reknown litigious society (a topic already commented upon by many people far smarter and more informed on this matter than I).
Comments?
Category: Open to Debate
Filed under: Government/Legislation; Medication/Prescriptions
Andrew Grove (former Intel CEO) and Justin Blum (a reporter for Bloomberg) both lament the sorry state of getting promising new drugs to patients...but from quite different perspectives.
Newsweek interviewed Mr. Grove just prior to a speech he was to give at the annual meeting of the Society for Neuroscience in early November 2007. Mr. Grove contrasts the slow pace of drug development with the "deeply felt conviction that what matters is time to market, or time to money" of semiconductor research.
Mr. Grove goes on to say, "The heart of every high-tech executive has been, get the product into customers' hands and ramp up production. That drive is just not present in pharma; the drive to get sufficient understanding and go for it is missing." He goes on to say "The peer review system in grant making and in academic advancement has the major disadvantage of creating conformity of thoughts and values. It's a modern equivalent of a Middle Ages guild..."
The report to the FDA includes:

"Science forms the basis of all regulatory decisions. Those that do not have adequate scientific support are thus subject to delays, or worse, poor decisions. Therefore, effective regulation requires that the scientific competency within FDA matches or exceeds an applicant’s knowledge." (Page 13)
So, is Mr. Grove right on, or is he perhaps missing an important (approval) point? Getting effective drugs to market isn't an "either-or" issue, but rather a complex mosaic of factors, which includes our world-reknown litigious society (a topic already commented upon by many people far smarter and more informed on this matter than I).
Comments?
Category: Open to Debate
Filed under: Government/Legislation; Medication/Prescriptions