The US House of Representatives on Wednesday is poised to pass a wide-ranging bill that will overhaul certain aspects of the US Food and Drug Administration (FDA) and provide the agency with more funding.
The 996-page bill, known as the 21st Century Cures bill and released last Friday, has already earned praise from the White House and is likely to pass the Senate, which will take it up early next week.
In addition to speeding up the approvals of new drugs, devices and biologics, which critics of the bill say could endanger patients, the bill also provides $500 million to FDA over 10 years and $4.8 billion over 10 years to the National Institutes of Health (NIH).
“We are the cusp of something special,” Rep. Frank Upton (R-MI) said on Wednesday, kicking off a series of statements of strong support for the legislation from a number of representatives on both sides of the aisle.
A final vote on the bill will come later Wednesday evening, though Rep. Rosa DeLauro (D-CT), Rep. Jim McDermott (D-WA), who's retiring, and Rep. Lloyd Doggett (D-TX) were the only representatives who did not offer support for the bill on the House floor on Wednesday.
Although FDA does not comment on pending legislation, the agency did help Congress craft parts of the bill. An FDA spokesperson told Focus: “As a matter of practice, FDA provides technical assistance to Congress on legislation to assess the impact of proposals on the agency’s mission to protect the public health.”
Rep. Frank Pallone (D-NJ), who said he supports the bill, raised a number of questions Wednesday on why the NIH funding included in the bill is not guaranteed (meaning it has to be reauthorized each year), why the bill does not provide more funding for FDA to implement many of the over-arching provisions, why the bill creates a new medical countermeasure priority review voucher program (when FDA is opposed to the others) and why it allows accelerated approvals for regenerative therapies.
Earlier this week, Sen. Chuck Grassley (R-IA) also expressed concern over a provision that would weaken drug and device company reporting requirements under the Physician Payments Sunshine Act and the bill was slightly amended on Tuesday to strike the provision.
On the Senate side, Sen. Dick Durbin (D-IL) took issue on Wednesday with the funding mechanism for the bill.
The legislation will be paid for with funds from the Prevention and Public Health Fund, created under the Affordable Care Act (also known as Obamacare), which DeLauro took issue with in expressing her opposition to the bill.
That fund has allocated more than $300 million to improve the public health immunization infrastructure, more than $100 million to raise awareness about the harms of tobacco use, as well as other allocations for Alzheimer's disease prevention education and outreach and grants to enhance diabetes prevention and to detect and respond to infectious diseases and other public health threats.
"I believe the standards in this bill are both weak and dangerous," DeLauro said.
Democratic Sens. Jeff Merkley (OR) and Elizabeth Warren (MA) joined Durbin in opposing the bill on Wednesday and Sen. Bernie Sanders (VT) has also said he’s opposed to the bill.
The House passed the previous version of Cures legislation in 2015 though that bill later stalled in the Senate.