Key US Senator Investigates FDA Over Rare-Disease Drug Denials

A key US Republican senator said he’s launched an investigation into the Food and Drug Administration’s recent denials of treatments for rare diseases, adding political pressure on an agency that’s already in turmoil.

Wisconsin Sen. Ron Johnson said he’s seeking the FDA’s written denials to drugmakers, known as complete response letters. He plans to write letters to the agency asking why it denied certain drugs. He said he’s also considering having top FDA officials, including Commissioner Marty Makary, testify before the Senate’s Permanent Subcommittee on Investigations that he chairs.

“The stories are so outrageous,” Johnson said in an interview ...