The Senate Health, Education, Labor and Pensions (HELP) Committee held a March 10 hearing titled, “Continuing America’s Leadership in Medical innovation for Patients.” National Institutes of Health (NIH) Director Francis Collins, M.D., Ph.D., and Food and Drug Administration (FDA) Commissioner Margaret Hamburg, M.D., testified.
In his opening remarks, Chairman Lamar Alexander (R-Tenn.) noted the committee has an opportunity to engage in “this exciting new era of medicine” by examining what Congress can do “to reduce the cost and the amount of time it takes to go from discovery…to the medicine cabinet or doctor’s office.”
Several Democrats on the committee, including Ranking Member Patty Murray (D-Wash.), Sen. Bob Casey (D-Pa.), Sen. Elizabeth Warren (D-Mass.), and Senate Appropriations Committee Vice Chair Barbara Mikulski (D-Md.) called for increased funding for NIH to help achieve this goal.
Ranking Member Murray said the “United States has always been a global leader in biomedical research and innovation, but today… sequestration threatens that leadership.” With the return of sequestration looming in fiscal year (FY) 2016, she asked Dr. Collins to describe the impact the last round of cuts had on NIH.
Dr. Collins said the prospect of sequestration “hangs over us like a dark cloud” and the $1.5 billion cut, which has not yet been restored, resulted in a “serious blow to momentum.” NIH funded 750 fewer grants and, Dr. Collins noted, those “very good ideas got left on the table.”
In terms of the impact on investigators, Dr. Collins said “success rates have dropped over the last ten years, since budgets became flat and inflation has been eroding away at our ability to fund research.” Dr. Collins also noted the nation is losing its global competitiveness and “potentially at risk of losing young investigators who are beginning to wonder if there is a future for them and some of them are starting to give up.”
Similarly, Sen. Mikulski asked what sustainability, predictability, and certainty mean for the agencies. Dr. Collins said sustainability is “crucial for biomedical researchers, especially for those who are early in their careers,” as is NIH’s ability to continue to fund good science.
Sen. Casey described a constituent whose life was saved by an experimental therapy discovered by NIH-funded researchers at Children’s Hospital of Philadelphia, and said the funding issues are “penny wise and pound foolish” when it comes to investments in NIH.
During the hearing, Chairman Alexander asked the agency heads to identify the barriers the committee could address to help move discoveries along more quickly. Dr. Collins noted the limitations around the attendance of scientists at scientific meetings is “incredibly vexing.” Dr. Collins said the agency spends approximately $16 million in oversight. He noted that attending conferences is a “critical part” of moving discoveries forward and how new ideas emerge, and the process “is very much being inhibited by this heavy-handed oversight.”
Dr. Collins also pointed out that the National Science Foundation and the Department of Energy are allowed to carry funds over, but NIH is not. Having the opportunity to carry funds over “does not cost a dime” and NIH could be more flexible in how we spend the taxpayer’s money.”
Dr. Hamburg noted that in order to advance treatments and cures, additional investments are needed in regulatory science, which “enables us to assess, in an effective and efficient way, the safety, efficacy, quality, and performance of a product.” She added, “It’s been an underappreciated, underdeveloped, and underinvested area of our overall biomedical product enterprise and it’s proving to be really essential as we are trying to take that last set of steps from research and development into a product that will really make a difference in people’s lives.”
Senators also discussed translational research, laboratory developed tests (LDTs), and antibiotic resistant bacteria, among other items.