Broadband, FDA User Fees and Cyber - Recap of House and Senate Hearings

On Tuesday, March 21st, the House Energy & Commerce Committee held a hearing, “Broadband: Deploying America's 21st Century Infrastructure,” which addressed barriers that hinder private sector investment in broadband infrastructure. The hearing focused on the importance of expanding access to broadband and how to include broadband in any future infrastructure development plan that the President or Congress could propose. Affordable and reliable broadband, particularly in rural and underserved areas, is critical for the deployment of telehealth services, and the issue is expected to continue to be a priority for the Committee.

Also on Tuesday, the Senate Health, Education, Labor & Pensions (HELP) Committee held a hearing, “FDA User Fee Agreements: Improving Medical Product Regulation and Innovation for Patients Part I,” which addressed the vital role of user fee agreements in enabling the FDA to review new medical products in a safe and timely manner. The hearing focused on the role user fee agreements play in funding the review of new and innovative drugs and medical devices, and the need for Congress to promptly reauthorize these agreements. 

Four different user fee agreements including the medical device user fee amendments (MDUFA), are set to expire on September 30th, and need to be reauthorized by July 30th,  in order to avoid layoff notices being issued to over 5,000 FDA employees.  In his opening statement, Chairman Lamar Alexander stated that “a delay in reauthorizing these agreements would delay the review of drugs and devices submitted after April […] the sooner we reauthorize the agreements, the better – to give patients, reviewers, and companies certainty.” 

The hearing featured three FDA witnesses including Dr. Jeffery Shuren, Director of the FDA Center for Devices and Radiological Health (CDRH), who explained how the next version of MFUDA, MDUFA IV will provide support for the National Evaluation System for Health Technology (NEST), and allow the “use real-world data collected as part of routine clinical care” to help evaluate and speed-up the approval of next generation devices.  

On Wednesday, March 22nd, the Senate Commerce Committee held a hearing entitled “The Promises and Perils of Emerging Technologies for Cybersecurity.” The hearing focused on the notion that as technologies such as artificial intelligence, block chain, and quantum computing, and the internet of things continue to advance, cyber threats are likely to arise. The hearing disused the economic benefits of continued technological innovation, but also the challenges of increased cyber-attacks as a result of a more interconnected world. The hearing featured witnesses from government and the private sector, who were in agreement on several themes, including the need for increased-public private cooperation on cybersecurity, issues around cyber workforce development and the need for both government and the private sector to move on from outdated legacy systems.