Group Advances Ideas to Improve Medical Device Availability

A group of former U.S. lawmakers is encouraging Congress to remove barriers to accelerating the development of medical devices for unmet needs.

Advancing Medical Innovation for a Healthier America, authored by members of the Bipartisan Policy Center, outlines four primary areas of recommended policy actions for enhanced access to both medical devices and drugs:

• Improving the medical product development process;
• Increasing regulatory clarity;
• Strengthening the FDA’s ability to carry out its mission; and
• Increasing investment in medical products to address unmet and public health needs.

“Americans cannot afford to rely on 20th century methodologies when the world is on the cutting edge of new health technologies,” BPC co-chairmen ex-Sen. William Frist, MD, and former Rep. Bart Gordon say in an introductory letter. “The hardworking FDA employees must be given the tools and support they need to succeed in this rapidly evolving field.”

Among the report’s recommendations is clarifying and allowing the increased sharing of scientific information related to the off-label use devices with healthcare professionals. As part of this provision, the FDA would clarify how manufacturers can disseminate truthful information about a device that is not included in approved labeling for the product.

In addition, Congress should require the FDA to establish a clear process for recognizing medical device standards and publish guidance on the topic. The agency also should commit to the harmonization of international standards, including those related to manufacturing facilities.

The FDA also should evaluate and prioritize use of real-world evidence to support postapproval study requirements and should engage stakeholders in this process, according to the report’s authors.

The report adds that Congress can help improve the agency’s internal review process by developing an interagency education and training program, as well as establishing a monitoring system to track progress on device review times.

Device reviews also can be improved by using public/private partnerships to augment internal resources, according to the report. These resources can help with the understanding of and access to more and complex technologies.

To read the report, visit www.fdanews.com/080315-innovation-fda.pdf. — Elizabeth Hollis