A US House of Representatives Committee has unanimously passed a bill that will speed up the time it takes to review medicines in the country whilst also placing a greater emphasis on the patient.
The ‘21st Century Cures Act’ as it is known will require the FDA to integrate patient experience into its decision-making processes whilst also restructuring its review of drugs for additional uses and consider more flexible forms of clinical trials, such as the use of real world data.
The bill was developed by the House Energy and Commerce Committee. This is the first step in the bill becoming ratified as a law – the next stage will see it voted by both House of Representatives and the Senate, which could be as early as next month.
In its current form the bill would increase funding to the National Institutes of Health by $10bn by 2020 and increase FDA funding by $550m over the same five-year period.
There would however be offsets to this, which currently include certain changes in government payments to insurance companies, and a reduction in Medicaid payments for some medical equipment.
This follows a recent push by the FDA to get more drugs through its regulatory process, with it passing 44 last year, a record high for 18 years.
The idea of patient-centricity has also become an increasingly important part of pharma’s policy, with patient groups pushing for greater integration of the patient’s experience into the drug development process.
Allowing patients’ voices to be heard during the FDA’s decision-making on a new medicine will likely have the effect of swaying the regulator and its committees as they have proven in the past to be powerful advocates of passing treatments, especially for diseases with an unmet medical need.
Jim Greenwood, president and CEO of the US trade group the Biotechnology Industry Organization, welcomed the plans.
He said: “We are pleased that the legislation prioritises placing patients at the centre of the drug development process, which we believe will help spur the development of therapies for the most prevalent conditions, as well as encourage development of treatments focused on unmet medical needs.
“Together with numerous patient groups, we strongly support establishing a framework for incorporating patient views into the development and regulatory review processes in a more structured and transparent way with respect to both patients’ input for benefit-risk assessments and use of patient experience data in regulatory decision-making.
“Furthermore, we support enhancing the FDA’s scientific capacity by improving access to adequate funding, enhancing the ability to recruit and retain world-class scientific and technical experts, and expanding management processes and human resource functions to meet the complexities of 21st Century scientific discovery. We especially note the important inclusion in this legislation of provisions to ensure privately-paid user fees to FDA are protected from the effects of any future sequestration.”