Co-sponsored by Republican Fred Upton and Democrat Diana DeGette, the bill, in the works for month, aims to speed the pace of drug cures by removing unnecessary barriers from the regulatory process.
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 FDA, 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.
Complete article in The New York Times: http://nyti.ms/1AphiXr