The current research, development, and regulatory process for drugs and devices is being hampered by inefficiencies that stand in the way of getting safe treatments and cures to patients more quickly and effectively.
That is the conclusion of a report issued Jan. 29 by Senators Lamar Alexander (R-Tenn.) and Richard Burr (R-N.C.) that takes aim at the U.S. Food and Drug Administration and the National Institutes of Health.
Every American is personally affected by the U.S. Food and Drug Administration and National Institutes of Health, states the report. Anytime we take medicine, have a routine check-up, or undergo a serious procedure for a health problem, like surgery or cancer treatment, we are using medical products regulated by the FDA. In many cases, the research leading to the discovery and development of these products has been advanced, funded, or enabled in some way by the NIH.
However, the report outlines the key problems in bringing promising medical products through the research, development, and regulatory review process, identifying the challenges at FDA and NIHinefficiencies, unnecessary regulatory burden, a lack of predictability, and ever-increasing regulatory coststhat the senators argue must be addressed.
Among the reports findings are five major themes:
*It costs too much to bring medical products through the pipeline to patients.
*As science and technology advance, the discovery and development process takes too long for medical products to make their way to patients.
*FDAs responsibilities have grown to include many activities unrelated to the core function of regulating medical products to advance the public health.
*The disparity in scientific knowledge at FDA and the fast pace of biomedical innovation are slowing, and in some cases, stifling innovation in American medicine.
*A working FDA is essential to continuing biomedical innovation in the United States and maintaining Americas global leadership in medical innovation.
The senators are soliciting feedback on their report as the Senate Health, Education, Labor and Pensions committee begins a bipartisan working group and a series of hearings to examine the time and cost currently involved with the drug and medical device discovery and development process, and how to better align public policies to support medical innovation.
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