Sen. Chuck Grassley (R-Iowa) is planning to examine the FDA’s orphan drug programs to find out if companies are using the designation to justify higher prices for common drugs.
Orphan Drug Act provisions appear to be “stretched beyond their original intent,” Grassley said, in a statement. His staff is meeting with interested groups and other Senate staff to “get their views on the extent of the problem and how we might fix it.”
Grassley said he was interested in the unanticipated uses of the orphan drug provisions, following a six-month investigation by Kaiser Health News, which found that drugmakers used orphan designations to create monopolies and protect their market exclusivity. Seven of the top 10 best-selling drugs in 2015 were orphan drugs, totaling over $32.5 billion in sales, according to the KHN report.