In September, we gave you a rundown of the major themes of the 21st Century Cures Roundtable discussions. This week, Chairman Fred Upton and the House Energy and Commerce Committee took the process to the next step by unveiling draft legislation addressing many of the roadblocks to medical innovation that we outlined, and some that we didn’t.
The 393-page draft is more than we can cover in a blog post, but following are some highlights:
- Funding – The bill doesn’t include any of the big increases that NIH and FDA advocates had had hoped for, but it doesn’t completely exclude funding either. Specifically, various sections of the proposal address how the health agencies should spend their money. A provision led by Rep. Cathy McMorris Rodgers (R-WA) would require the NIH to implement the National Pediatric Research Network Act, while another section would remove restrictions on funding for clinical trials at NCATS. The bill also would authorize additional funding for the NIH Common Fund and the NIH BRAIN Initiative. Whether that translates into real money for NIH would depend on subsequent appropriations.
- Encouraging Young Scientists – The draft legislation includes language drawn from a proposal by that would take NIH funds that would normally be drawn for the “evaluation tap” and redirect them to grants for first-time grantees.
- Collaboration – In order to address collaborations issues, there are a few efforts in the bill to increase the availability of data. For instance, the legislation would require NIH grantees to share their data, and there’s placeholder language to “work toward the goal of a national interoperable health information infrastructure.” There is also language to free up data in health care facilities for use in research as well as a “Sense of Congress” provision to encourage NIH and FDA to collaborate with the EU, industry and others to establish a global pediatric clinical trial network.
- Patient Participation – FDA, under this legislation, would be required to inject patient experience data into the drug approval process, including data on what patients want from a treatment and what they are willing to risk. On the clinical trial side, there is language establishing a data sharing framework to help patients and physicians find appropriate clinical trials.
- FDA Turnover – As we discussed in the earlier blog, there is a high turnover rate FDA due to high demand for their expertise outside the agency. There isn’t much in the bill to stop this from happening, but there is placeholder language for a provision on hiring and language requiring the FDA to submit a succession plan for management positions. On a federal employee note, there are several places in the bill that appear to expand travel for federal employees so that they may attend appropriate outside conferences. This would be a big win for the science community.
- Regulatory Burden – The draft includes provisions aimed at reducing regulatory burdens, including language allowing the FDA to accept data summaries rather than full data packages to add indications to a drug label, and reducing the time and costs for new technology developers who seek CMS coverage of their products. There is also language to develop a working group to streamline the grant process for grants at NIH.
This bill is far from finalized and its future is far from determined. The day the bill was released, Rep. Diana DeGette (D-CO), the Democratic cosponsor of the effort, withdrew her support from this version while offering that she would continue to work with Chairman Upton on final language. The Committee continues to look to the public, industry, and advocates for input as they seek to spur medical innovation in the 21st Century.
(As this blog was being prepared, Senate HELP committee chair Lamar Alexander (R-TN) and Senator Richard Burr (R-NC) launched their version of the House 21st Century Cures Initiative by unveiling a report identifying areas in need of improvement within FDA and NIH, and soliciting feedback from stakeholders on ways to improve drug and medical device development. We will devote a future blog to the Senate version as soon as details become available.)