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Expansion of FDA Oversight Power Sought

Posted on: Tuesday, 13 May 2008, 03:00 CDT

By Anonymous

In the wake of high-profile problems with drugs such as Avandia and Vioxx as well as concerns about the safety of imported food, members of Congress are continuing to push for an expansion of the Food and Drug Administration's (FDA's) oversight authority. In September 2007, Congress approved and the president signed a major FDA reauthorization bill that gives the agency new powers to regulate prescription drug safety, enabling it to require pharmaceutical companies to conduct postmarket safety studies or to change the information on product labels. But senior members of Congress, including House Energy and Commerce Chairman John Dingell (D-MI) and Senate Finance Committee Ranking Member Charles Grassley (R-IA), have continued to call for an overhaul of federal drug and food safety practices.

In September, Energy and Commerce Committee Democrats proposed a bill that would impose user fees that would provide the FDA with more funding for inspecting food imports, give the agency authority to recall food products, and limit entry points for food imports to those near the FDA's 13 inspection labs. The user-fee and port- limit proposals have drawn fire from some industry stakeholders.

In October, the committee released a report about China's food inspection practices that Dingell said was "first-hand confirmation that food from China presents a clear and present danger to Americans under the current conditions of import." The report indicated that China's certification process is inconsistent. In addition, the FDA does not recognize that process, meaning that firms that don't earn the certification can still export to the United States.

In November, a White House panel released an import safety plan that would give the FDA recall authority, though it cautioned that the U.S. government cannot "inspect its way to safety." At the same time, the FDA announced its own food safety plan that seeks to focus its resources on the riskiest areas.

Rep. Rosa DeLauro (D-CT) and Senate Majority Whip Dick Durbin (D- IL) plan next year to take a different tactic by introducing a bill that would split the FDA into two agencies: one with jurisdiction over food and the other over drugs and medical devices.

The FDA inspects only about 1% of imported food, although it electronically scans all of it. The percentage of imported drugs that are inspected also numbers in the single digits. A recent Government Accountability Office (GAO) report discussed at a November 1 Energy and Commerce subcommittee hearing estimated that the FDA inspects approximately 7% of the foreign pharmaceutical manufacturers that export goods to the United States in a given year. Although the agency must inspect domestic drug plants every two years, there is no requirement for inspecting foreign facilities, and the FDA lacks a dedicated overseas inspection staff as well as an adequate tracking system. Causing further consternation to committee members was the fact that the GAO examined the issue and came to some similar conclusions nearly 10 years ago. Dingell called it a case of "deja vu."

FDA Commissioner Andrew von Eschenbach said that the agency is taking steps to improve information flow, including meeting with Chinese government officials. He has also put the brakes on a proposal, strongly criticized by some members of Congress, to close half of the agency's inspection labs.

Another oversight issue for the FDA involves a bill passed in August by the Senate Health, Education, Labor and Pensions Committee that would authorize the agency to regulate tobacco. Eschenbach sent testimony to the House Energy and Commerce Committee opposing the legislation on the grounds that the already stretchedthin agency is geared toward promoting health, not overseeing a harmful product.

An Institute of Medicine panel came to a different conclusion, however, saying in May 2007 that the FDA is the best federal agency to deal with tobacco. The bill's supporters include the strange bedfellows of antismoking groups and the tobacco giant Philip Morris, which, as the market leader, would stand to benefit from overarching limits on tobacco advertising.

Copyright Issues in Science and Technology Winter 2008

(c) 2008 Issues in Science and Technology. Provided by ProQuest Information and Learning. All rights Reserved.

Source: Issues in Science and Technology

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