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US Still Gold Standard Amid FDA Process Changes, Says Acadia CEO
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March 16, 2026
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6:47Now PlayingCatherine Owen Adams, CEO of Acadia Pharmaceuticals, said that the United States is still the 'gold standard' for pharmaceutical safety and innovation amid revisions to the FDA's approval process and leadership shakeups. Owen Adams said that the company is trying to work in a 'bipartisan way' to make it easier and cheaper for patients to get necessary pharmaceuticals.
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 Monday with Bloomberg News. “It just appears that they’re looking for excuses to say no.”
Johnson’s comments came after the FDA has refused to approve treatments for several rare diseases, and demanded additional studies before it would consider approving others, sparking an outcry from patient advocates and investors.
He called the agency’s recent request for a new trial of UniQure NV’s experimental gene therapy for Huntington’s disease “bureaucratic idiocy.”
“You’re expecting people to go through sham surgeries where they get holes drilled in their heads?” Johnson said. “That’s just unbelievable.” The FDA has denied that the surgery would require people in the control group to get holes drilled in their heads.
The agency has said it’s largely following the recommendations of staff scientists and that approvals in general have not gone down.
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