FDA probed over rare-disease drug denials |
Wisconsin Sen. Ron Johnson has launched an investigation into denials of drugs for rare diseases by the US Food and Drug Administration. Johnson said he plans to write letters to the agency asking why it denied certain treatments, and 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. “It just appears that they’re looking for excuses to say no.” Andrew Nixon, a spokesman for the Department of Health and Human Services, which oversees the FDA, responded: “The FDA stands by the scientists evaluating these applications and each rationale is explained in detail through CRLs, which for the first time, are made available to the public,” the spokesman, said in a statement.