Flurries Of New Bills Advance Device Industry Interests In Congress

Article preview from "The Gray Sheet"- October 17, 2011

The first legislative salvos were launched last week in a battle that is sure to escalate in conjunction with device user fee reauthorization efforts next year.

Flurries Of New Bills Advance Device Industry Interests In Congress

Article preview from "The Gray Sheet"- October 17, 2011

On Oct. 13, Sen. Amy Klobuchar, D-Minn., introduced the industry-supported Medical Device Regulatory Improvement Act, which seeks to streamline FDA’s pre-market device oversight with guidelines directing the agency not to ask companies for more data than it needs.

The bill responds directly to complaints from device companies that FDA reviewers are increasingly relying on overly burdensome and inconsistent standards.

On the following day, 10 bills were introduced by House Republicans, most with the goal of speeding up and adding predictability to the FDA device review process.

None of the bills are necessarily expected to move forward independently. But they begin to shape the congressional debate over reauthorization of the FDA user fee program, which expires in September 2012.

Of note, the Senate legislation was sponsored by two Democrats – Klobuchar and Michael Bennet, of Colorado – and one Republican, North Carolina’s Richard Burr.

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