Bipartisan legislation to spur medical innovation and hasten the availability of such products to patients was introduced on Thursday.
Sen. Amy Klobuchar (D-Minn.), chairwoman of the Senate Commerce Competitiveness, Innovation, and Export Promotion Subcommittee, sponsored the Medical Device Regulatory Improvement Act to streamline the Food and Drug Administration's regulation of medical devices by clarifying the agency's least burdensome requirements. The bill would direct FDA regulators to focus only on “relevant information” during the decision-making process; consider “appropriate alternatives” to reduce the time, effort and cost of reaching regulatory decisions; and use “all reasonable mechanisms” to reduce review times when making their decisions.
“In order to provide American patients access to the most cutting-edge medical therapies and advances, we need to fix what is broken at the FDA by restoring regulatory certainty and predictability,” Sen. Richard Burr (R-N.C.), a co-sponsor of the bill, said in a written statement.
The legislation comes amid increasing protests from device makers that the FDA’s approval process has lengthened and increased in difficulty in recent years, resulting in the delay or derailment of new devices. For instance, industry-backed research has found that the average time to approve a 510(k) application has increased 43% from the period between 2003 and 2007 compared to 2010.
The new bill drew support from medical devicemaker advocates.
“We are especially encouraged to see the legislation’s focus on clarifying FDA data requirements, streamlining agency management processes, and its emphasis on the importance of attracting the best experts to FDA advisory committees,” Stephen Ubl, president and CEO of the Advanced Medical Technology Association, said in a written statement.