We know it’s a top priority for Congress, but a group of panelists speaking at an “emergency briefing” in the U.S. Senate this week hosted by an anti-FDA legal co have urged lawmakers to not “rush a closed-door negotiated version of the bill during the lame-duck session.”
The 21st Century Cures Act, which is essentially seeking to speed up its regulatory processes for new meds and medical devices even further while adding billions in research dollars to the NIH and new funding to the FDA, has been in Congress for around a year but the biopharma industry, which is backing the bill, wants it pushed through asap.
But not all are happy for its to go through as is, with law firm Emord and Associates, which is run by Jonathan Emord, a man described as having “defeated the food and drug administration more times in federal court than any other attorney in American history,” looking to “expose the under-the-radar consequences” of passing the bill.
Justin Bogie, senior policy analyst in fiscal affairs at the Heritage Foundation, said on the issue of mandatory funding in the bill that this tends to put programs on “autopilot” and then they are not adequately reviewed to see if they are beneficial.
He said: “Congress should reject the 21st Century Cures Act in its current form . . . This bill would set a bad precedent that could have negative impact on other legislation, and the budget as a whole, in the future.”
Panelist Dr. Diana Zuckerman, president of National Center for Health Research, said a large number of drugs that showed promise in early stages of review went on to be proven ineffective, or worse, in later stages, adding that this was a concern given that the bill will allow for approval based on early stage indicators. […]
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