Monday
Jun142010
New Study Shows FDA Regulations Are Hurting Patients
By Linn Grubbstrom - Talk Radio News Service
The Food and Drug Administration's (FDA) regulations have caused delays in the development of new drugs, costing patients far more than they cost producers. This is the result of a report presented by Tomas Philipson, Ph.D. of the University of Chicago and Eric Sun, M.D., Ph.D. of Stanford University.
"The main costs of drug delays to producers are not the clinical trial process being long and costly. The main cost to them is the forgone profits of delayed sales," said Philipson. "The second costs that have been ignored is the cost of patients that are waiting for these drugs to go on the market."
The study looked at the economic and health related consequences FDA regulations have for patients suffering from HIV, breast cancer and non-Hodgkin's lymphoma. In the first case, results showed that access in the market would be worth $16,000 for each patient and the total value for these patients would be $19 billion. These are all costs that can be slashed, according to the authors.
"In our report, we list a few policy recommendations such that make it easier to recruit patients into clinical trials, using bio markers to track a drug's effectiveness opposed to clinical outcome," said Sun.
The Prescription Drug User Fee Act (PDUFA) was enacted in 1992 and authorizes the FDA to collect fees from companies that produce certain human drug and biological products.
The Food and Drug Administration's (FDA) regulations have caused delays in the development of new drugs, costing patients far more than they cost producers. This is the result of a report presented by Tomas Philipson, Ph.D. of the University of Chicago and Eric Sun, M.D., Ph.D. of Stanford University.
"The main costs of drug delays to producers are not the clinical trial process being long and costly. The main cost to them is the forgone profits of delayed sales," said Philipson. "The second costs that have been ignored is the cost of patients that are waiting for these drugs to go on the market."
The study looked at the economic and health related consequences FDA regulations have for patients suffering from HIV, breast cancer and non-Hodgkin's lymphoma. In the first case, results showed that access in the market would be worth $16,000 for each patient and the total value for these patients would be $19 billion. These are all costs that can be slashed, according to the authors.
"In our report, we list a few policy recommendations such that make it easier to recruit patients into clinical trials, using bio markers to track a drug's effectiveness opposed to clinical outcome," said Sun.
The Prescription Drug User Fee Act (PDUFA) was enacted in 1992 and authorizes the FDA to collect fees from companies that produce certain human drug and biological products.
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Eric Sun, Linn Grubbström, PDUFA, Tomas Philipson, drug, fda in News/Commentary
Eric Sun, Linn Grubbström, PDUFA, Tomas Philipson, drug, fda in News/Commentary
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