Who Is Responsible for Rising Drug Costs?

To a significant degree, over-priced drugs are a problem exacerbated by the regulatory regime at the U.S. Food and Drug Administration (FDA), coupled with a lack of guidance from Congress. One way to rein-in high drug prices is to inject more competition into the drug market. Costly drugs would face numerous competitors if it did not require $1 billion or more, on average, to bring new products to market. With more competition, it would be difficult for drug makers to maintain high prices.

The 21st Century Cures Act, signed by president Obama in December 2016, aims to streamline the approval process for new drugs. It allows the FDA to consider aggregate anecdotal data as evidence and take patient experiences into account, rather than being limited to rigid and costly double-blind clinical trials. However, the Cures Act will likely fall short of what needs to be done to streamline the drug approval process.

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