House Energy and Commerce Leaders Offer Bills to Revise FDA Device Rules

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By Nathaniel Weixel

House Energy and Commerce Committee leaders Oct. 14 introduced a series of bills they said would reform the Food and Drug Administration's medical device review process in order to protect innovation.

The 10 bills, all sponsored by Republicans, provide “solutions to improve the predictability, consistency, and transparency of FDA's medical device review and approval process,” the committee said in a statement. The package is called “Saving American Jobs and Saving American Patients.”

According to the committee, FDA'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.”

The bills were sponsored by Republican Reps. John Shimkus (Ill.), Brian P. Bilbray (Calif.), Cathy McMorris Rodgers (Wash.), Charles F. Bass (N.H.), Michael C. Burgess, (Texas), Mike Rogers (Mich.), Brett Guthrie (Ky.), and Erik Paulsen (Minn.).

A staff-prepared memo circulated to all committee members said that ”the current regulatory environment created by FDA has forced some device companies to cut American jobs and move overseas. It also has hurt American patients because the approvals of life-saving and life-improving treatments have been delayed or denied. Finally, it has harmed American innovation as venture capitalists and other investors no longer view U.S. device companies as good, reliable investments.”

According to the memo, the bills would make FDA regulation more predictable, consistent, transparent, and efficient, while maintaining the current safe and effective approval standard.

The title of the memo is “Ten Bills to Fix FDA's Medical Device Regulation: Saving American Jobs and Saving American Patients.”

The bills are:

• the Premarket Predictability Act (H.R. 3209), authored by Shimkus;

• the Novel Device Regulatory Relief Act of 2011 (H.R. 3203), authored by Bilbray;

• the Keeping America Competitive through Harmonization Act (H.R. 3230), authored by McMorris Rodgers;

• the Humanitarian Device Reform Act of 2011 (H.R. 3211), authored by Bass;

• the Patients Come First Act (H.R. 3208), authored by Shimkus;

• the Cultivating Scientific Expertise to Foster Innovation Act (H.R. 3206), authored by Burgess;

• the FDA Mission Reform Act (H.R. 3214), authored by Rogers;

• the Modernizing Laboratory Test Standards for Patients Act (H.R. 3207), authored by Burgess;

• the Guidance Accountability and Transparency Act (H.R. 3204), authored by Guthrie; and

• the FDA Renewing Efficiency from Outside Review Management Act of 2011 (H.R. 3205), authored by Paulsen.

Clinical Lab Regulation

The bills were introduced as part of the FDA reform plan deal with topics ranging from oversight of clinical laboratories, the “de novo” device clearance process, and FDA's use of guidance documents.

For example, Burgess introduced the proposed Modernizing Laboratory Test Standards for Patients Act, which would clarify that FDA does not have authority over laboratory-developed tests (LDTs).

The bill would establish a notification and review process at the Centers for Medicare & Medicaid Services—which now regulates the safety of clinical labs—that would allow the agency to evaluate the clinical validity of all LDTs and direct-to-consumer tests.

Currently, FDA regulates diagnostic tests only if they are developed and sold by device manufacturers as diagnostic kits, regardless of whether they were developed by clinical laboratory companies for in-house testing or by manufacturers for use in kits. The lab tests that are developed internally by a company generally are not subject to FDA review. CMS regulates those types of lab tests under the Clinical Laboratory Improvement Amendments (CLIA).

According to the memo, there is concern that FDA and CLIA regulation will create unnecessary and costly regulatory duplication.

The de novo process involves reviews of devices that do not have a substantially equivalent product already on the market. According to the House panel's memo, the proposed Novel Device Regulatory Relief Act from Bilbray would streamline the de novo classification process by striking the requirement that a sponsor receive a “Not Substantially Equivalent finding” before entering the de novo process, thus “making the process more efficient.”

Guidance Documents

FDA often utilizes guidance documents to explain the agency's positions.

The proposed Guidance Accountability and Transparency Act, authored by Guthrie, 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. If the agency is not able to comply, it would require FDA to provide an explanation. The bill also would require FDA to finalize draft guidance documents by a certain date.

According to the memo, FDA sometimes writes guidance documents without engaging experts in the field and soliciting input. “The result of this process is that the guidance documents, some of which are not thoroughly vetted and made effective immediately, on numerous occasions have created uncertainty and significant implementation issues.”

Least Burdensome Requirements

The proposed Premarket Predictability Act (PPA), authored by Shimkus, would reaffirm the least burdensome provisions added during the Food and Drug Administration Modernization Act of 1997 (FDAMA). These provisions were enacted to streamline the review of new devices.

This bill follows on the heels of a bill introduced in the Senate Oct. 13 (S. 1700 ) by Sens. Amy Klobuchar (D-Minn.) and others, also involving the least burdensome provisions (see related item).

The House bill from Shimkus would require reviewers to provide the scientific or regulatory rationale for major decisions and establish an expedited approval appellate process. Finally, according to the committee, the PPA would establish two investigational device exemption pathways to create more flexibility in conducting trials for device clearance/approval.

Support From Trade Groups

Stephen J. Ubl, president and chief executive officer of the Advanced Medical Technology Association (AdvaMed), in a statement expressed support for the entire legislative package. Ubl said that the bills “reflect the Energy and Commerce Committee's extensive work in examining the need for reform through hearings and debate.”

“We support this effort because it is an excellent starting point in a legislative discussion that will address several important issues critical to maintaining our global leadership and competitiveness,” Ubl said. “We commend the bills' sponsors for working to make the FDA approval process more efficient and predictable, a key component of AdvaMed's Competitiveness Agenda.”

The American Clinical Laboratory Association (ACLA) announced its “full and strong” support for the proposed Modernizing Laboratory Test Standards for Patients Act, introduced by Burgess.

ACLA President Alan Mertz in a statement commended Burgess for “modernizing the regulatory structure created by the Clinical Laboratory Improvement Amendments of 1988 (CLIA). This legislation offers a modern, innovative, and flexible approach that builds on the success of CLIA,” Mertz said. “It avoids regulatory overlap and redundancy, while assuring consumers that laboratory developed tests are reliable and accurate. This is a balance that will encourage continued innovation and protect consumers.”

Meanwhile, the top Democrats on the Energy and Commerce Committee have urged the panel to focus more on the safety of devices for consumers rather than the burden on industry.

The Democrats Oct. 12 sent a letter to the Republican committee leaders, urging them to hold hearings to examine medical devices that have developed serious defects after being implanted in patients. The Democrats said that the panel has focused on FDA's regulation of devices, and the hearings held thus far “primarily served as forums for critics of the FDA who allege that the FDA regulatory process for devices harms patients and has a negative impact on jobs” (see related item).

Public Citizen Expresses Disappointment

The bills were met with disappointment from one prominent patient advocacy group.

Michael Carome, deputy director of the health research group at Public Citizen, told BNA Oct. 17 that a constant mantra of this Congress is that the best way to promote business is to remove regulation. The result is frequently to the detriment of the average citizen, Carome said.

“Rather than weakening, regulations need to be strengthened,” Carome said. He noted that the group supported the Institute of Medicine's recent recommendation that FDA's premarket review standards need to be upgraded (5 MELR 503, 8/10/11). “[IOM] said the system was broken because the standards were inadequate. They were sound recommendations,” Carome said. “This package would be moving in the opposite direction, and would cause harm to patients.”

The Energy and Commerce staff memo is at .


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