The 21st Century Cures Act seeks to ease the path to FDA approval for drug and device companies, but if Sen. Elizabeth Warren, D-Mass., gets her way, the long-awaited bill could stall once again. On Nov. 28, Warren took to the Senate floor to voice her opposition to the legislation, which has been bumping around Congress since last year.
Warren also took to Twitter, saying she’d fight the bill because “I know the difference between compromise & extortion.” She also charged that the pharmaceutical industry had “hijacked” the bill.
Warren opposes several provisions of the revised bill, including the amount of money it allocates for the National Institutes of Health, Warren said, according to Stat. The original Cures Act, which passed the House last year, called for nearly $9 billion in NIH funding over five years. The revised bill, released over Thanksgiving, would provide the NIH just $4.8 billion. The act includes funding for the precision medicine initiative, Vice President Joe Biden’s cancer moonshot and Alzheimer's research. But the $500 million allocated for FDA funding is less than what Democrats had been fighting for, according to Stat.
Warren called the rehashed bill a “fig leaf,” expressing concerns that the money wouldn’t even be available unless Congress passes more bills to allocate the funding to specific projects. She also blasted other provisions that she said amounted to “huge giveaways” to the pharma industry.
For example, one provision of the new 21st Century Cures Bill would eliminate some of the requirements of the Sunshine Act, a law passed in 2010 that requires drug and device makers to track and report their financial relationships with doctors. The Cures Act, if passed, would allow companies to avoid reporting fees they give to doctors that are related to journal articles, continuing medical education or textbooks. Senator Charles Grassley, R-Iowa, who first introduced the Sunshine Act, agrees with Warren that those reporting requirements shouldn’t be eliminated.
Congress has also come under pressure from outside groups urging the legislators not to rush into a less-than-ideal lame-duck compromise. At a Congressional panel earlier this month, an analyst for the Heritage Foundation warned that the Cures Act in its current form would “set a bad precedent” that could have a negative impact on future legislation and on the federal budget.
Some elements of the revised bill aren’t so controversial, including the $1 billion it allocates in state grants to fighting opioid addiction. Still, Warren isn’t backing off as the bill comes up for a vote in the House possibly this week.
Now Democrats on the House Energy and Commerce Committee are reviewing the language in the bill again, according to a statement they e-mailed to US News & World Report. They promise to propose "additional changes to the bill that are important to Democrats in order to garner strong bipartisan support."