Letter Supporting “Saving American Jobs and Saving American Patients" Bills
TO THE MEMBERS OF THE COMMITTEE ON ENERGY AND COMMERCE:
The U.S. Chamber of Commerce, the world’s largest business federation representing the interests of more than three million businesses and organizations of every size, sector, and region, recognizes the introduction of the package of bills called “Saving American Jobs and Saving American Patients” as an important step forward in the effort to improve the predictability, consistency, and transparency of the Food and Drug Administration’s (FDA) medical device review and approval process.
Medical device companies are a critical engine of the U.S. economy, driving technological innovation creating both more effective life-saving treatments for patients and more jobs. While the FDA recognizes these virtues and favors efforts to optimize the review process, the current system impedes innovation and forces some device companies to cut American jobs and move overseas. Procedural flaws harm American patients because approvals for critical devices and treatments are delayed or improperly denied. Venture capitalists and other investors who fund the highly dynamic and entrepreneurial device sector are deterred from investing in U.S. device companies by delays and significant regulatory uncertainty. Legislative action is clearly needed.
The “Saving American Jobs and Saving American Patients” package of bills, includes 10 bills: the Premarket Predictability Act (H.R. 3209); the Novel Device Regulatory Relief Act of 2011 (H.R. 3203); the Keeping America Competitive through Harmonization Act (H.R. 3230); the Humanitarian Device Reform Act of 2011 (H.R. 3211); the Patients Come First Act (H.R. 3208); the Cultivating Scientific Expertise to Foster Innovation Act (H.R. 3206); the FDA Mission Reform Act (H.R. 3214); the Modernizing Laboratory Test Standards for Patients Act (H.R. 3207); the Guidance Accountability and Transparency Act (H.R. 3204); and the FDA Renewing Efficiency from Outside Review Management Act of 2011 (H.R. 3205). This package contains the intellectual architecture for optimizing FDA’s device review and approval process without compromising patient safety or medical efficacy. Enactment and implementation of the measures contained in these bills would make FDA’s medical device approval process more predictable, transparent, and efficient, while maintaining FDA as the international regulatory “gold standard” for safety and efficacy.
The Chamber looks forward to working closely with the Committee, the FDA and other stakeholders to move this important issue forward and to enact effective FDA medical device review reforms.
R. Bruce Josten
Cc: The Honorable Margaret Hamburg, Commissioner, Food and Drug Administration