US House passes 21st Century Cures Act
Under the bill, the FDA would see new authority to approve antibiotics, as well as new leniency with using biomarkers and other surrogate endpoints to more easily approve new drugs.
The bill also would require FDA, in the context of the new drug review process, to implement a “structured framework to facilitate the incorporation of patient experiences in the consideration of a drug’s benefits and risks,” according to the House Energy and Commerce committee report.
The bill also includes a number of provisions that will impact CROs (contract research organizations), including the establishment of a national pediatric research network, the standardization of inclusion and exclusion criteria across ClinicalTrials.Gov, and encouraging the use of master protocols to speed drug development.
The bill also calls on the FDA to issue guidance on assisting sponsors in incorporating adaptive designs and Bayesian statistical modeling into proposed clinical protocols and applications are in the bill.
Despite its passage, the White House and others are raising a number of concerns over how the bill would be paid for and what it will actually do to speed new cures to the market.
Legislators are looking to pay for the bill largely through the sale of 64 million barrels of crude oil from the Strategic Petroleum Reserve, which would reduce the size of the reserve by about 10%.
Harvard professors also recently took issue with the way the bill would speed new products to market: “An underlying premise of the bill is the need to accelerate approval for new products, but this process is already quite efficient. A third of new drugs are currently approved on the basis of a single pivotal trial; the median size for all pivotal trials is just 760 patients.
"More than two thirds of new drugs are approved on the basis of studies lasting 6 months or less — a potential problem for medications designed to be taken for a lifetime.”