The U.S. House of Representatives' Energy and Commerce Committee's Subcommittee on Health has laid out its vision for the future of drug and device regulation in a draft bipartisan bill. And the plan has significant implications for the use of health data in R&D and other topics related to biotech IT.
Many areas of drug development could be affected by the 393-page bill, which is the result of 9 months of discussions including more than 20 roundtables and congressional hearings, Alec Gaffney explains in his comprehensive breakdown of the text for Regulatory Focus. Biotech IT is particularly affected by 10 sections, which collectively call for a reshaping of how health data is shared and used to advance R&D and patient care..
"[These sections] would establish a data sharing framework to enable patients and physicians to better identify ongoing clinical trials [and allow] researchers and developers to use Medicare data for the purposes of improving the quality of patient care," the subcommittee wrote in its summary of the bill. The creation of a de-identified database of clinical trial data for R&D purposes and the sharing of all results from projects funded by the National Institutes of Health are among the proposals.
The Association of Clinical Research Organizations (ACRO) welcomed the plan to increase data sharing and use of real world evidence, but other groups have reacted negatively, an unsurprising outcome given the scope of the draft and the boldness of some of the proposals. Legislators are now listening to feedback and talking among themselves to figure out which proposals can win bipartisan support and advance beyond the discussion draft.
- read the draft bill (PDF)
- here's the subcommittee's summary (PDF)
- check out Regulatory Focus' coverage
- and the ACRO statement