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.
Representing some veterans’ concerns, panelist Major Eric Montalvo, U.S. Marine Corps (Ret.) said: “As a result of provisions in the bill that reduce testing requirements and expedite processes, the bill will place veterans at greater risk of adverse consequences.”
Emord himself noted the already large number of drug and device recalls as a result of damages suffered by individuals in the public.
He said: “Though the FDA's medical scientists may recommend rejecting a product, too often political managers, beholden to industry, override them and grant approval. This bill comes at a time when the FDA is broken. Without rectifying this, the bill gives more power and discretion to the agency managers responsible for the dangerous products.”
The law firm also notes that a majority of Americans do not think the FDA is doing a good job of regulating safety and effectiveness, citing a poll examining public opinion on the 21st Century Cures Act and the similar Senate package, conducted by medical news service Stat and Harvard TH Chan School of Public Health.
Biopharma certainly wants this through, and Senate Majority Leader Mitch McConnell said it was a major priority after the election of president-elect Donald Trump earlier this month.
The feeling is that a Trump/Republican led government will look to ease down on medical regulation, a situation that has in general pleased the biopharma industry, and helped a biotech shares rally after his electoral victory, and was further boosted when he said he wanted to “reform the FDA,” although just what this means remains, like many of his policies, vague.
Before the election there had been growing concerns from some corners that the bar is being set lower and lower for the FDA to approve new meds, and Cures is also fueling some of that fear.
A major flashpoint came with the controversial September approval for Sarepta’s DMD med Exondys 51 (eteplirsen), with several FDA experts questioning why such weak evidence led to a regulatory green light.