Economic Value Before Approving Products

The U.S. Food and Drug Administration’s (FDA) mandate is to ensure the safety and efficacy of health care products. Recently, a report done by PricewaterhouseCoopers revealed a slim majority of consumers think that the FDA should consider costs when it approves new medical devices or drugs. This would mean that the FDA not only evaluates products’ safety and efficacy, but also their economic value. This stems from the reality that products can have the same function and efficacy, yet differ immensely in their costs. The most popular example of this was seen at the Memorial Sloan-Kettering Cancer Center in 2012, when the facility refused to use a colon cancer drug due to its cost and the fact that it was stated to be no more effective than a similar but less expensive drug. Doctors at Sloan-Kettering publicized the center’s decision last month in an article in The New York Times. They said, “ignoring the cost of care is no longer tenable” and that “soaring spending has presented the medical community with a new obligation. When choosing treatments for patients, we have to consider the financial strains they may cause alongside the benefits they may deliver.” The drug in question was introduced into the market at a price of about $11,000 a month to patients, but its effects of improving median survival were almost identical to another drug that was effectively half the price.