A Year for Failure: Regulatory Policy News in 2007

In 2007, new regulatory policies and the inability of federal agencies to protect the public made headlines more so than at any time in recent memory. Four themes dominated regulatory policy this year: an increase in White House influence over agency rulemaking activity and discretion, which added a perception of more political manipulation; the inability of the federal government to protect the public by ensuring the safety of imported goods; the voice of some industry groups calling for regulation; and the Bush administration's refusal to regulate in the face of overwhelming scientific evidence, as in the case of climate change. At best, government has attempted to respond to crises instead of getting ahead of the curve. This has left the public uncertain about whether we can count on our government to provide adequate safeguards.

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More of the Same: Import Safety Panel Leaves Business in Charge

The Bush administration's cabinet-level Interagency Working Group on Import Safety released its final report Nov. 6 on ways to improve the safety of food and consumer products imported into the U.S. The report calls for limited increases in some federal agencies' responsibilities but does little to change the current voluntary regulatory scheme that governs some $2 trillion worth of products, 800,000 importers and more than 300 ports-of-entry.

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Congress Told of FDA's Lax Inspection of Foreign Drug Makers -- Again

The Government Accountability Office (GAO) recently told Congress that the U.S. Food and Drug Administration (FDA) inspects an estimated seven percent of foreign drug manufacturing facilities. GAO can only provide an estimate because FDA doesn't know how many foreign facilities are subject to inspection due to inaccurate and uncoordinated databases that have vastly different estimates of the number of drug makers subject to the foreign drug inspection program. At this inspection rate, it would take FDA more than 13 years to inspect all existing facilities one time, assuming no additional facilities were added to the list.

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Bush Administration Delays Import Safety Changes While Congress Debates Solutions

The Bush administration and several of its regulatory agencies have been reluctant to address the safety of consumer goods as more recalls of harmful toys and contaminated foods occur. They seem content to delay substantive changes that could improve product safety. Congress, meanwhile, is trying to sort through the many legislative proposals to restore regulatory capacity to agencies and fix the fragmented U.S. import system.

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Congress Expands FDA User Fee Program, Reforms Drug Safety Process

Congress has passed legislation which will reauthorize a program allowing the U.S. Food and Drug Administration (FDA) to collect fees from pharmaceutical companies in order to conduct drug approvals. The bill will also dramatically expand FDA's regulatory authority in response to recent controversy. President George W. Bush is expected to sign the bill into law soon.

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Senate Reviews Agencies' Attempts to Preempt Congress and the States

The Senate Judiciary Committee held a hearing Sept. 12 about federal agencies' practice of inserting into regulations language that removes consumers' ability to sue under state tort law those corporations whose products cause harm. In addition, the use of this preemption language limits the ability of state and local governments to protect the health, safety and welfare of their citizens. Federal preemption removes the targeted policy area from state and local jurisdiction and makes it almost exclusively a federal policy issue.

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Amidst Increased Scrutiny, FDA Wants to Shut Testing Labs

Amidst increased scrutiny by the public and Congress of the problems with food imports and instances of bacterial outbreaks in the domestic food supply, the U.S. Food and Drug Administration (FDA) plans to close 7 of 13 laboratories that test for food safety.

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U.S. Ability to Regulate Chinese Imports in Question

The United States government is struggling to ensure the safety of consumer products and food imported from China, as evidenced by a recent spate of controversies involving dangerous Chinese-made products. While America's consumer product safety net is relatively strong, China's young market economy is largely unchecked by government regulators. Subsequently, dangerous Chinese products are finding their way to American shores where federal agency officials are unable to monitor the volume of imports.

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Senate Passes FDA Reform Bill, Expands User Fees

On May 9, the Senate ended weeks of debate and passed S. 1082, the Food and Drug Administration Revitalization Act. The two primary aims of the bill are to renew the Prescription Drug User Fee Act and to generally strengthen the regulatory authority of the U.S. Food and Drug Administration (FDA).

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