The Government Accountability Office has added enhanced oversight of devices, drugs and other medical products to its list of "high risk" priorities.

Specifically, a Jan. 22 GAO report to Congress cites concerns with foreign manufacturing inspections, post-market monitoring, promotional materials and clinical trial oversight related to devices and drugs.

"Many have begun expressing concern about FDA's ongoing ability to fulfill its mission of ensuring the safety and efficacy of drugs, biologics and medical devices," the GAO ¹ report states.

Growing demands on FDA have outpaced its resources, GAO notes, echoing similar concerns raised by FDA's own Science Board advisors and others (² Also see "Funding Advice From FDA Science Board: Double Total Over Next Five Budgets" - Pink Sheet, 3 March, 2008., p. 5).

GAO has released a list of government operations that it considers "high risk" about every two years since 1990, usually prior to the start of a new Congress. The reports are meant to draw attention and resources to the most critical areas in various parts of government. The 2009 update includes 30 items in total.

Foreign Inspections Found Lacking

FDA oversight of foreign manufacturers is plagued by inconsistent foreign establishment databases, difficulties scheduling and conducting foreign inspections and other hurdles, the GAO report states.

According to one estimate, the agency inspects only about 8 percent of registered foreign establishments in a given year. FDA estimates that it inspects overseas facilities manufacturing high risk devices about every six years (³ Also see "FDA Ups Foreign Inspections In Fiscal 07; Visits 11% Of Establishments" - Pink Sheet, 27 October, 2008., p. 6).

The Department of Health and Human Services has agreed that FDA should conduct more foreign inspections, but has not provided a timetable for accomplishing this, GAO says.

The report also says FDA lacks a "clear and effective" process for making decisions about post-market safety issues, and points out weaknesses in the agency's ability to oversee the protection of human subjects in clinical trials.

FDA Has Made Some Progress, GAO Concedes

FDA has already made some progress toward improving oversight in these areas, such as foreign inspections, post-market safety and health IT.

For example, the agency opened two new offices in India this month. Overseas offices were also opened recently in Costa Rica and China.

In addition, FDA's post-market improvement efforts have passed a few milestones in the past year, with the launch of the agency's Sentinel electronic post-market safety surveillance system and progress toward an enhanced MedWatch Plus all-electronic adverse event reporting system (⁴ [A#05160380009], p. 12 and ⁵ Also see "Current MedWatch Form Stays While More Changes Could Occur Later In 2008" - Pink Sheet, 18 February, 2008., p. 12).

GAO's response to FDA's efforts is cautiously optimistic, but indicates that the agency still has work to do.

"To make a meaningful difference, these initiatives will require effective implementation," the report states. "Although such initiatives may hold promise, we nonetheless believe that FDA needs to enhance its oversight of medical products to better protect public health."

Medicare Program Still Considered Risky Business

Two other areas added to the 2009 high risk list involve modernizing the outdated U.S. financial regulatory system and transforming the Environmental Protection Agency's processes for controlling toxic chemicals.

The only item removed from the previous list, issued in 2007, was the Federal Aviation Administration's air traffic control modernization.

Modernizing and safeguarding the Medicare program remains among the high risk concerns on the updated list. GAO says the Centers for Medicare and Medicaid Services have made progress in the past two years toward improving program management and in reforming and refining its payment methods, but that the program remains vulnerable to mismanagement and improper payments. Medicare has been on the high risk list since 1990.

- Jessica Bylander (j.bylander@elsevier.com)

Enhanced FDA Oversight Added To GAO’s “High Risk” List

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