With Nod To Biden, Senate To Say Yes To "Cures" Spending, Reform Bill
Summary
If the ACA is repealed, as President-elect Donald Trump and Congressional Republicans have vowed to do as quickly as possible, it is unclear if that funding would continue.In the Senate, critics like Bernie Sanders (I-VT) and Elizabeth Warren (D-MA) have said the bill’s loosening of FDA standards, or promises of faster reviews, were crafted to benefit drug and device makers, not patients.Some of the reforms in the bill require FDA to accept more patient input and include real-world data—from daily medical practice, not just from clinical trials—as part of its evaluation of products.At a meeting in June, Commissioner Rob Califf told the audience that higher quality real-world data could one day be used to bolster clinical evidence.Drug approvals will always be driven by the quality of the science behind the R&D, he said, but “as the data environment changes, the regulatory environment will change.” The Cures Act attracted the official attention of 1,455 lobbyists on all sides, making it one of the most lobbied bills of the 114th Congress, according to analysis of disclosure records by Kaiser Health News.