Legislative Update

BUSINESS NEWS

In April, FDA proposed recommendations to Congress for reauthorizing the Medical Device User Fee and Modernization Act. The proposal—designed to provide companies with more-predictable fee schedules and improved review times—has been endorsed by industry associations AdvaMed (Washington, DC) and the Medical Device Manufacturers Association (Washington, DC). For more information, go to www.fda.gov/cdrh/mdufma.

Bipartisan patent reform legislation is currently moving through the House and the Senate. The bill, which is similar to legislation introduced last year, would establish a first-to-file patent system and limit the situations in which damages may be trebled for willful infringement.

In March, the Medicare Advanced Laboratory Diagnostics Act (HR 1321) was introduced in the House of Representatives. According to AdvaMed, the legislation will reform Medicare policies that currently discourage the development and adoption of new clinical diagnostic laboratory tests, and will establish a demonstration project to evaluate a new Medicare payment system for molecular diagnostic tests.