President Signs PDUFA Renewal/FDA Reform Bill

Today, President Bush signed into law H.R. 3580, the Food and Drug Administration Amendments Act of 2007. The law reauthorizes the Prescription Drug User Fee Act, an important source of funding for FDA, just in time to avoid agency layoffs. The law should also improve the ability of the agency to assure the safety of prescription drugs after they have been approved for the market.

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Latest Watcher

Be sure to check out the latest issue of our biweekly newsletter, The Watcher. Regulatory policy articles this time: Congress Hears Pleas for Expanded Authority and Resources at CPSC New White House Guidelines Fit into Broad Attack on Federal Protections Senate Reviews Agencies' Attempts to Preempt Congress and the States

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More on the California Waiver Controversy

Earlier, Reg•Watch blogged about the concerted lobbying efforts of senior administration officials intent on killing an effort by the state of California to enact its own greenhouse gas reduction program.

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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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Don't Go into the Water: It's Not the Jellyfish, It's the Sewage

Jellyfish aren't the reason U.S. beaches are being closed — it's sewage, and legislation in the Senate and House seeks to ensure that people know when sewage is in their water.

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NRC to Release Documents on Spill

The Nuclear Regulatory Commission (NRC) has revoked a three-year-old secrecy policy and plans to release documents from two nuclear fuel processing plants in response to congressional demands. This about-face was precipitated by a congressional inquiry into a uranium leak kept secret from the public for more than a year.

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Administration Lobbies to Kill California Emissions Plan

The Bush administration engaged in a broad, multi-agency effort to lobby congressmen and governors to urge them to oppose a California plan to reduce greenhouse gas emissions, according to a recent investigation. In December 2005, California petitioned EPA to let the state develop its own program and standards for regulating greenhouse gas emissions from vehicles. Under the Clean Air Act, the federal government holds the express right to regulate emissions but may grant waivers to states, which it often does. If EPA grants California's waiver request, 11 other states could follow suit.

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New White House Guidelines Fit into Broad Attack on Federal Protections

The White House has issued new guidelines for federal agencies in conducting risk analysis. Risk analysis, of which risk assessment is a central factor, is a process by which agencies identify and evaluate risks such as toxic exposure or structural failure. Risk analysis often lays the scientific or technical foundation for public health and safety rulemakings.

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Congress Hears Pleas for Expanded Authority and Resources at CPSC

A proliferation of children's product recalls due to potentially dangerous exposure to lead has left many turning to the federal government for answers. The Consumer Product Safety Commission (CPSC) has borne much of the brunt for the regulatory failures. Congress is considering solutions including new federal standards for lead, expanding the agency's regulatory authority and increasing agency resources.

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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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