Congress set up the orphan drug designation to help bring drugs affecting small numbers of patients to market. To entice companies, the government allows drugs that meet the sought-after orphan designation to get a fee waiver, a tax credit for the drug’s trials, support from the Food and Drug Administration and seven years of market exclusivity. Many of the drugs are expensive, with some reaching $70,000 a month.
KHN’s coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation.
