The final draft of the US 21st Century Cures Act has been released and a vote on it in the US House of Representatives is set for tomorrow, as GenomeWeb has reported.
This latest version contains $4.8 billion in funding for National Institutes of Health programs, including the Precision Medicine Initiative and the Cancer Moonshot program, GenomeWeb added. The bill also has a provision to expedite the drug-review process at the Food and Drug Administration as well as a requirement for the agency to accept "so-called 'real-world' evidence," Stat News adds, to bolster new uses for drugs and to fulfill post-market requirements.
"The House vote on Wednesday will be an extraordinary opportunity to help almost every American family," Rep. Fred Upton (R-Mich.), the chair of the House Energy and Commerce Committee, and Senator Lamar Alexander (R-Tenn.), chair of the Senate Committee on Health, Education, Labor, and Pensions, said in a joint statement.
The bill previously passed the House in July 2015 with flying colors, though Stat News points out that it has been the subject of numerous hearings and debates. In particular, it says that financing of the bill and its provisions concerning the FDA have been sources of worry. However, it adds that the financing concerns have been largely resolved as President-elect Donald Trump has promised to dismantle much of the Affordable Care Act and those freed-up funds could now be used to pay for part of this bill. Other financing may come from selling oil from the strategic petroleum reserves.
At the same time, Sen. Elizabeth Warren (D-Mass.) has called the bill "extortion," the Chicago Tribune reports. She further says that it would "legalize fraud" as it weakens the scientific evidence needed to approve existing drugs for new uses. "I cannot vote for this bill. I will fight it because I know the difference between compromise and extortion," Warren says.
The bill is to go before the Senate next week.