The Senate Health, Education, Labor and Pensions (HELP) Committee March 24 held a hearing titled, “Continuing America’s Leadership: Advancing Research and Development for Patients.”
The hearing, the second in an expected series of hearings focused on medical innovation, featured witnesses from the private sector and academia who discussed their role in advancing research and development, as well as their interactions with the National Institutes of Health (NIH) and the Food and Drug Administration (FDA).
In his opening remarks, HELP Committee Chair Lamar Alexander (R-Tenn.) expressed interest in learning how Congress may be able to help reduce the time it takes to get drugs, devices, and treatments from the discovery process, through the regulatory process, and into medicine cabinets and doctor’s offices. The Chairman also expressed interest in learning how Congress can help “decrease red tape and administrative burden.”
In that vein, Chairman Alexander asked the panel about the amount of money spent on administrative costs, and noted that it could be an area to identify dollars that could be spent on additional grants. Bruce Sullenger, Ph.D., director of Duke Translational Research Institute, said researchers are spending increasing amounts of time on regulatory issues, some, he said, do not pass the “common sense test.” He also described the “stress” on the research process, stemming from the limited budget environment and NIH’s success rates.
Ranking Member Patty Murray (D-Wash.) said medical innovation is at a “critical moment” and added Congress must “give our nation’s biomedical community the right tools to innovate for patients, now and for generations to come.” She also noted the importance of looking at the entire spectrum of medical innovation – from basic research, to development and approval, and into the post-market setting. However, she cautioned that speed must not come at the expense of safety, adding “we need to ensure we are both encouraging innovation and upholding the highest standards of patient and consumer protection.”
Senator Elizabeth Warren (D-Mass.) expressed concern about the lack of adequate funding for NIH and criticized Congress for “choking off vital funding for medical research” over the last ten years. Sen. Warren asked panelists about the impact of the funding environment on their work in the private sector. Panelists noted the lack of funding sustainability or predictability has had in the venture capital space; the loss of talented researchers to other countries or jobs; and because of the time it takes from discovery to treatment, the lost scientific potential for additional drugs or treatments.
Before closing the hearing, Ranking Member Murray expressed concern about the impact of sequestration and budget cuts on families who are waiting for cures.
Members of the committee also expressed interest in FDA’s approval times, the use of medical data, improving the efficiency of clinical trials, engaging patients and families in the research continuum, and reimbursement issues once drugs or devices make it into the system.