US drugs bureaucracy is costing money and lives
By
Friday, June 18, 2010
The Food and Drugs Administration (FDA) continues to thwart Americans’ access to new life-saving medicines, costing billions of dollars and uncountable lives. An article in the Washington Examiner notes the huge value of innovative new drugs, and equally the cost of delaying them for just one year:
“For HIV/AIDS patients, the value of one year's earlier access would've been $19 billion. For breast cancer patients being treated with trastuzumab, the value of one year's earlier access would be $8 billion.”
And the FDA has even made confessions about their bureaucratic inertia:
"FDA's inability to keep up with scientific advances means that American lives are at risk. While the world of drug discovery and development has undergone revolutionary change... FDA's evaluation methods have remained largely unchanged over the last half century."
The author of the article points to a lack of funding for processing of new drugs, when compared to money spent on other regulatory spending on (supposed) innovation. But it may be better to look at the incentives which cause skewered funding and an illogical, harmful emphasis on caution above innovation.
In a previous paper released by IPN, Corinne and Robert Sauer explore such incentives, and suggest alternative market-based methods of approving new pharmaceuticals. These solutions may seem radical, but more than ever they need to be considered.



