Legislation that would have accelerated the pace of federal drug approvals in a way that critics said threatened to erode patient safety was formally released this week, in a scaled-back version with many of the most controversial provisions left out.
The draft bill presented at a hearing in the House on Thursday represents a less aggressive streamlining of the drug approval process, critics of the earlier draft said, and seems to have secured strong bipartisan support.
The legislation, called 21st Century Cures, has been in the works for months. Its lead sponsor, Fred Upton, Republican of Michigan, said it would speed the pace of drug cures by removing unnecessary hurdles from the regulatory process.
Critics, including top officials at the Food and Drug Administration, had expressed concern that the changes would risk patient safety — for example, by potentially permitting shorter clinical trials and letting drug companies use alternative measures of health as evidence of a drug’s effectiveness and safety.
The bill’s supporters said it was a work in progress that had been assembled in one of the most collaborative, transparent processes Congress has seen in years. The sponsors held eight hearings and more than a dozen round-table meetings in districts across the country to gather comment. […]
Diana Zuckerman, the president of the National Center for Health Research, said earlier versions of the legislation had “considerable micromanaging of the F.D.A. and enormous power given to industry.”
She added, “Most of that is gone.”
But she cautioned that the bill still held numerous provisions she believed put people at risk, including ones she described as lowering standards for the approval of medical devices and antibiotics. The bill would increase the work the F.D.A. must perform, but not the money it receives, and Dr. Janet Woodcock, an agency official who testified Thursday, said that was a concern.
“We are very stretched in our resources,” she said.
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