FDA reform package announced

After Detailed Committee Review, Members Offer Ten Specific Solutions to Top Ten Challenges in Current Review Process that Slow Access to Vital Devices

October 14, 2011

WASHINGTON, DC – The United States for decades has led the global medical device industry, providing life-saving and life-improving devices to patients and employing more than two million people in device-related jobs.  However, the Food and Drug Administration’s unpredictable, inconsistent, and non-transparent handling of the review process has threatened our nation’s medical device leadership, hurting patients, American jobs, and innovation. After hearing from patients, inventors, investors, and employers, committee members from both sides of the aisle introduced ten legislative solutions to improve the predictability, consistency, and transparency of FDA’s medical device review and approval process.

The committee staff prepared a memo to members summarizing the committee’s findings this year, which includes background on the current problems with FDA’s regulation of medical devices and details on the ten legislative solutions.

Summary of Legislation

The Premarket Predictability Act, authored by Rep. John Shimkus (R-IL), reaffirms the “least burdensome” provisions already included in the law but which appear not to have been followed in recent years. These provisions were enacted to streamline the review of new devices. Second, the PPA would require reviewers to provide the scientific or regulatory rationale for major decisions and establish an expedited approval appellate process. Finally, the PPA would establish two Investigational Device Exemption pathways to create more flexibility in conducting trials for clearance/approval.

Novel Device Regulatory Relief Act of 2011, authored by Rep. Brian Bilbray (R-CA), streamlines the de novo (lower risk devices) classification process by striking the requirement that an applicant submit a 510(k) application before entering the de novo process.

Keeping America Competitive through Harmonization Act, authored by Rep. Cathy McMorris Rodgers (R-WA), requires FDA to enter into agreements, when feasible, with Tier One countries on methods and approaches to harmonize regulatory requirements for premarket review, inspections, and common labels.

Humanitarian Device Reform Act of 2011, authored by Rep. Charles Bass (R-NH), fosters the increased development of devices for those with rare diseases that affect fewer than 4,000 patients by removing the current profit cap and clarifies the 4,000 patients limit applies per year.

Patients Come First Act, authored by Rep. John Shimkus (R-IL), reaffirms the mandates of the Safe Medical Devices Act of 1990 that FDA require Premarket Approvals from the more complex, pre-amendment Class III devices or move them to Class II. The act also codifies GAO’s recommendations that Congress reform FDA’s current device recall authority.

Cultivating Scientific Expertise to Foster Innovation Act, authored by Rep. Michael C. Burgess, M.D. (R-TX), fixes FDA’s conflict of interest policies to ensure the most knowledgeable experts are able to serve on FDA advisory committees.

Food and Drug Administration Mission Reform Act, authored by Rep. Mike Rogers (R-MI), clarifies that establishing a predictable, consistent, and transparent regulatory environment, facilitating innovation and applying a patient-focused, risk-benefit framework is part of FDA’s mission to ensure the agency takes them into account.

Modernizing Laboratory Test Standards for Patients Act, authored by Rep. Michael C. Burgess, M.D. (R-TX), clarifies that FDA does not have authority over Lab-Developed Tests, which are developed within labs and not sold as medical devices, and Direct-to-Consumer Tests.

Guidance Accountability and Transparency Act, authored by Rep. Brett Guthrie (R-KY), requires public notice and involvement in the development of level 1 guidance documents, which set forth initial interpretations of law or changes in interpretation of regulatory requirements, and if the agency is not able to comply, requires FDA to provide an explanation. The bill also requires FDA to finalize draft guidance documents by a certain date.

FDA Renewing Efficiency from Outside Review Management Act of 2011, authored by Rep. Erik Paulsen (R-MN), reauthorizes the third party inspection program and reforms the third party review program to foster better participation, decrease approval times and conserve FDA resources.