AdvaMed Criticizes House Medical Device Bill
by Barbara Kram, Editor | June 19, 2007
Congress’ draft of
legislation could put
FDA’s authority at risk
(click to enlarge)
legislation could put
FDA’s authority at risk
(click to enlarge)
WASHINGTON, D.C. -- In recent testimony before the House Energy & Commerce Health Subcommittee, AdvaMed President and CEO Stephen J. Ubl expressed a number of concerns with a House discussion draft of legislation to reauthorize the Medical Device User Fee and Modernization Act (MDUFMA).
"Although we strongly support reauthorization of the user fee agreement reached between FDA and the medical technology industry earlier this year, we have serious concerns with a number of provisions in the House discussion draft, particularly proposals that could undermine FDA's preemptive authority to ensure timely access to safe and effective devices," Ubl said.
Ubl commended the subcommittee for including the FDA/industry agreement in the discussion draft but he said that a number of new provisions that were added are very troubling for industry. Following is a summary of some of the provisions Ubl identified as objectionable.
-- Limitation on Federal Preemption -- The draft bill includes language which could have the effect of limiting the preemptive effect of FDA's device-specific actions, including premarket approval. Elevating individualized state actions and decisions through tort lawsuits over FDA's expert science-based determinations of safety and effectiveness would undercut the agency's authority and creates a disincentive for companies' research and development efforts.
-- Omission of Third-Party Inspection Program Improvements -- Failure to include process changes to streamline the third-party inspection program threatens the existence of a program which is critical to freeing up FDA resources and reducing costly and duplicative inspections.
-- Clinical Trial Registration Policy -- House language calling for public registration of clinical trial data would not provide useful information to patients or physicians deciding whether to use the device, and would create significant disadvantages to medical technology innovation. Premature disclosure of clinical trial data in a registry may reveal important proprietary information, which is particularly harmful to small device companies. The House draft diverges from the Senate-passed S. 1082, which delays the posting of medical device trial data until the product is cleared or approved.
AdvaMed also opposes pediatric device provisions that would limit access to medical technology and place undue burdens on manufacturers. Discussions are underway with a number of House Members to address industry objections before a final draft is presented for mark up. AdvaMed urges the House to join the Senate in passing legislation that aligns with the FDA-industry agreement.
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"Although we strongly support reauthorization of the user fee agreement reached between FDA and the medical technology industry earlier this year, we have serious concerns with a number of provisions in the House discussion draft, particularly proposals that could undermine FDA's preemptive authority to ensure timely access to safe and effective devices," Ubl said.
Ubl commended the subcommittee for including the FDA/industry agreement in the discussion draft but he said that a number of new provisions that were added are very troubling for industry. Following is a summary of some of the provisions Ubl identified as objectionable.
-- Limitation on Federal Preemption -- The draft bill includes language which could have the effect of limiting the preemptive effect of FDA's device-specific actions, including premarket approval. Elevating individualized state actions and decisions through tort lawsuits over FDA's expert science-based determinations of safety and effectiveness would undercut the agency's authority and creates a disincentive for companies' research and development efforts.
-- Omission of Third-Party Inspection Program Improvements -- Failure to include process changes to streamline the third-party inspection program threatens the existence of a program which is critical to freeing up FDA resources and reducing costly and duplicative inspections.
-- Clinical Trial Registration Policy -- House language calling for public registration of clinical trial data would not provide useful information to patients or physicians deciding whether to use the device, and would create significant disadvantages to medical technology innovation. Premature disclosure of clinical trial data in a registry may reveal important proprietary information, which is particularly harmful to small device companies. The House draft diverges from the Senate-passed S. 1082, which delays the posting of medical device trial data until the product is cleared or approved.
AdvaMed also opposes pediatric device provisions that would limit access to medical technology and place undue burdens on manufacturers. Discussions are underway with a number of House Members to address industry objections before a final draft is presented for mark up. AdvaMed urges the House to join the Senate in passing legislation that aligns with the FDA-industry agreement.
Back to HCB News
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