In a rare display of bipartisanship, Congress overwhelmingly passed The 21st Century Cures Act, and the president signed the bill into law on December 13th, 2016. This legislation boosts funding to the National Institutes of Health and establishes an innovation grant fund to “accelerate the discovery, development, and delivery” of new treatments and therapies.
Here are parts of the law which are most likely to directly impact future diabetes treatment research:
Section 2037 – Translational Medicine
New drug and device development has become so prohibitively expensive that few manufacturers can shoulder the development cost from idea to pivotal clinical trial or even raise the necessary capital in the financial markets. Pipeline diabetes therapies especially have benefited from breaking down research projects into discrete stages, with early stage investigational trials financed by industry, government, or philanthropic grant, and later trials conducted under the U.S. Public Health Service’s National Center for Advancing Translational Sciences. The Cares Act expands when the U.S. Public Health Service may offer assistance in the clinical trial process.
Section 3038 – Combination Product Innovation
The Cures Act authorizes the Secretary of Health and Human Services to “designate a primary agency center to regulate products that constitute a combination of a drug, device, or biological product” and to conduct the review under a single application. This provision is an attempt to streamline the regulatory processes for novel treatments like the dual-hormone bionic pancreas (“the iLet”), being designed by Beta Bionics. Currently, a product that combines new treatment with a new device must jump through two sets of regulatory hoops to get approval by the FDA.
Section 3058 – Least Burdensome Device Review
Although the Cures Act does not alter the existing standards for ensuring safety and efficacy for Class III [highest risk] medical devices, the Act does add new provisions about regulating pre-market review of Class III devices. One requires the FDA to “consider the least burdensome…means necessary to demonstrate a reasonable assurance of device safety and effectiveness.” FDA staff who oversee device applications must be trained in what “least burdensome” means.
The bill also appropriates $500 million to an FDA Innovation Account to support patient-focused drug development, modernized trial design, and enhanced patient access to new therapies.
This 21st Century Cures Act was not without visible and influential critics. On November 29th, Senator Bernie Sanders (D-VT) said on his website that the bill “provided absolutely no relief for soaring drug prices.” He criticized the bill for lowering the threshold for determining reasonable assurance of drug safety; he also claimed the bill weakened legal protections and patient confidentiality guarantees for individuals who are participating in clinical trials.
Senator Elizabeth Warren (D-MA), speaking the day before on the Senate floor, accused the pharma lobby of “highjacking” the bill as a vehicle to ease regulatory protection against marketing of unproven drugs. She also said the bill opened the door to easy off-label use of FDA-cleared drugs. “I know the difference between compromise and extortion,” she said.
Lobbying for the bill’s passage, the White House press office issued a November 30th statement saying, “Like all comprehensive legislation, the bill is not perfect, and there are provisions the Administration would prefer were improved, but the legislation offers advances in health that far outweigh these concerns.“
Insulin Nation will track how the clinical trial landscape will change as this bill is implemented into law.
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