Major Medical Innovation Legislation Inches Forward in US Congress: Would Have Sweeping Impact on NIH and FDA

Congress is not expected to accomplish much before the general election season begins in earnest this summer, but there is broad bipartisan support for accelerating the discovery, development, and delivery of promising new therapies.

With overwhelming support, the House of Representatives passed major legislation in July 2015 called the 21st Century Cures Initiative that would spur medical innovation and drug development at the National Institutes of Health (NIH) and Food and Drug Administration (FDA). The Senate is currently considering advancing a similar legislative package of its own. This spring, the Senate held three hearings and passed 19 bills that incorporate about 50 different legislative measures.

Measures in the House and Senate bills would remove barriers to increased research collaboration, help the next generation of scientists, streamline administrative burdens, promote the development of drugs for rare diseases, modernize clinical trials, incorporate patient perspectives in the drug development and regulatory review process, and remove regulatory uncertainty for the development of new medical apps.

ASN actively provided input on these measures during the drafting of the legislation. ASN’s comment letters are online at https://www.asn-online.org/policy/.

Similarities between the House and Senate bills

Both the House and Senate bills include a number of similar provisions. They would facilitate NIH opportunities for new researchers and research independence, Precision Medicine Initiative research, development of new therapies for rare diseases, and the collection and use of patient experience data in drug development.

In addition, they would allow NIH’s National Center for Advancing Translational Sciences to support certain clinical trials through Phase III, give the NIH director more discretion over the appointment of other NIH leaders, and require NIH to provide Congress intermittent strategic plan updates.

The bills would also include provisions to streamline the FDA’s combination product review process, expedite the review process for medical devices, and exempt most health software and apps from device review requirements.

Differences between the House and Senate bills

There are several notable differences between the House and Senate bills. On the House side, provisions would require NIH to prioritize pediatric disease research and maintain the scientific workforce, and require the Department of Health and Human Services (HHS) that administers NIH and the FDA to reconcile human test subject rules. House provisions would also require both the NIH and FDA to provide public data in a unified and accessible format and to initiate a study on the use of telehealth services for dual-eligible patients.

On the other side of the Capitol, Senate provisions would require NIH to identify opportunities for reducing health disparities, improving research related to minority populations, and increasing diversity in clinical research. Senate provisions would also require NIH to establish a working group to enhance research rigor and reproducibility, and HHS to reduce administrative burdens associated with compliance of electronic medical records regulations.

Next steps

Funding remains the chief obstacle to Senate passage. The House bill would increase annual funding for the NIH and FDA by $1.86 billion through 2020, and negotiations continue in the Senate where there is limited support for a smaller increase specifically for a few NIH programs. Key Democrats in the Senate are refusing to support the legislative package unless it includes supplemental funding.

If a legislative package passes, the House and Senate would then need to reconcile their bills and vote on a joint, combined bill again. Unfortunately time is running out. There are a limited number of congressional working days before Congress recesses for the start of the general election season.

After the November election, lawmakers will return for a short lame duck session of Congress and have a number of other pressing priorities to address before the next session of Congress starts in early January 2017, when lawmakers would have to start all over again.

“ASN commends Congress for advancing these meaningful reforms to spur medical innovations and cures that will save lives and improve the care of patients with kidney diseases,” ASN Secretary-Treasurer and Public Policy Board Chair John R. Sedor, MD, FASN, remarked. “I hope lawmakers act swiftly to send a bill that includes supplemental funding for NIH and the FDA to the President before the congressional calendar runs out.”