Scientific research funding is a no-brainer, yet over the past few years, it’s been a contentious issue in Washington D.C. American science research over the last century is estimated to’ve had a return of 30-100%, but concerns over how to pay for new funding have stymied new bills. Recently though, research advocates were buoyed by positive news out of the Senate Health, Education Labor & Pensions Committee, which advanced seven counterpart bills to the House’s 21st Century Cares Act legislation to the full Senate on February 9. Here’s a breakdown of the legislation:
This bill would help speed the “development, review and approval of genetically targeted drugs” aimed at rare diseases and slight genetic mutations of existing diseases. Companies would be able to use data from previously approved drug applications of their own or of other companies that allow a contractual right of reference. This could potentially cut years off the lead time for new treatments.
Reforming the requirements for medical devices and premarket applications, this bill requires the FDA to “consider the least burdensome appropriate means necessary to demonstrate a reasonable assurance of device safety and effectiveness.” The act also calls for revised guidance regarding effectiveness of in vitro diagnostic testing, and allows for multi-center clinical trials overseen by a central institutional review board.
In the wake of several high profile incidents where standard cleaning did not properly sterilize instruments, this bill would clarify medical device safety regulations, putting in place specific requirements for “cleaning, disinfection, and sterilization.” Proposed labels and instructions for use would also have to be submitted along with validation data for new device applications.
The Next Generation Researchers Act works to bring in and develop new researchers to the NIH by improving their opportunities. It would allow for greater research independence, increased mentorship, workplace diversity, career training, and make funding more readily available to new researchers.
S.800 calls for a regularly updated, “comprehensive” plan for medical rehabilitation research under the auspices of the National Center for Medical Rehabilitation Research (NCMRR), which supports research aiding “individuals with physical disabilities resulting from diseases or disorders of the neurological, musculoskeletal, cardiovascular, pulmonary, or any other physiological system.”
Similarly, S.849 calls for “systematic data collection…analysis and epidemiological research regarding Multiple Sclerosis (MS), Parkinson’s disease, and other neurological diseases.” Carried out primarily by the CDC, the bill also calls for collaboration with other government agencies as well.
The bill calls for the “reduction of regulatory…[and] administrative burdens” related to electronic health records, and for a new comprehensive strategy to seek improved collection, storage, security, and patient access.