Here's a couple interesting commentaries from Seeking Alpha and The Economist -- both having to do with issue of the high cost of drugs (particularly cancer treatments) and the future regulatory role in not only evaluating the science behind them but their cost-effectiveness too.
Both pieces use the FDA's recent decision that Avastin does not usually work with breast cancer and a lightning rod for the discussion. The Seeking Alpha piece predicts that the FDA will become more like its EMA counterpart and will not only make decisions on a drug's suitability on safety and efficacy grounds (as it does now) but will increasingly weigh its cost-effectiveness. The argument is that it will become even harder to get FDA approval and that bodes poorly for the financial health ofthe pharma sector.
The Economist is less predictive in what may happen but notes that Americans spent $125 billion on cancer treatments in 2010 and are proejcted to spend $207 billion by 2020 (according to Medco). Thus, they predict that the FDA will have to engage in a serious discussion soon about "how much society should pay for the extension of life." As do we all.
Posted by Bruce Lehr July 1st 2011.