FDA Helpless in Regulating Drug Industry

The New Standard reports that neither the FDA nor the pharmaceutical industry have proven the safety of hundreds of drugs already approved for the market. How does such a regulatory gaff occur? From the article by Michelle Chen: Under the Federal Food, Drug, and Cosmetic Act, the FDA can approve drugs despite unresolved safety concerns, but it can also require further studies by the manufacturer once a drug is released onto the market. The problem is manufacturers aren't holding up their end of the bargain. According to an FDA notice in the Federal Register, for FY 2006, 71 percent of the required further studies are pending and 3 percent are delayed. Meanwhile, only 15 percent are ongoing and a mere 11 percent have been submitted.

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Latest Watcher

Be sure to check out the latest issue of our biweekly newsletter, The Watcher. Reg policy articles this time: Media, Congress Begin to Examine Bush's Executive Order on Regulatory Process Congress Steps Up Oversight of Executive Branch

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Bush Budget Attacks the Environment and Product Safety

Yesterday, President Bush released his budget for FY 2008. Many of the president's budgetary priorities are hostile toward Americans, but three will particularly hinder the federal government's ability to regulate.
  • Bush is calling for a $300 million slash in the EPA's budget. In a press statement, EPA Administrator Stephen Johnson defended the cut, proving he is more interested in toeing the administration line than sticking up for his own agency or protecting the environment.
  • Bush is also continuing his war on climate science by cutting the budget of the U.S. Climate Change Science Program (CCSP) by seven percent, according to BNA news service (subscription).
  • Finally, Bush is calling for only a nominal increase in the budget of the Consumer Product Safety Commission (CPSC), the independent agency that is charged with recalling potentially dangerous products. The increase amounts to a budget cut when adjusted for inflation. According to BNA, the proposal includes calls for the lowest staffing levels in the agency's history.

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The Bush Assault on Climate Science

On Tuesday, the House Government and Oversight Committee, captained by Rep. Henry Waxman (D-CA), held an oversight hearing investigating the Bush administration's meddling in climate science. The hearing featured the release of a joint report by the Union of Concerned Scientists and the Government Accountability Project. The good people over at Think Progress have summarized the report, in which about half of the scientists interviewed report some kind of interference. There are 435 instances of manipulation reported. Try to pick your favorite. Waxman was provoked into holding the hearing when the Bush administration repeatedly refused to allow Congress to review certain documents related to global climate change. At the hearing, Waxman announced he will be re-requesting those documents. Hopefully, with the issue gaining more media attention, the administration will not continue to misinform the public on global warming. The Bush Assault on "Global Warming" On a similar note, the Bush administration appears to be waging war on "global warming." No, not the environmental crisis, just the phrase. At the hearing, Rep. Jim Cooper (D-TN) revealed that Director of National Intelligence John Negroponte is prohibited from using the phrase "global warming." Read more on that here. In another effort, rumors are flying on the blogosphere that the White House website search function turns up only one result when users search for “global warming.” Keep your eye out for more on this lame attempt to censor legitimate science.

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Little Chance for Vote on Vitter Amendment

The Vitter amendment appears to be dead. This afternoon, the Senate overwhelmingly voted to end debate on the minimum wage bill. (A final vote on minimum wage is expected later this week.) Only ten senators opposed the motion to end debate including, you guessed it, David Vitter. Thanks to those who contacted their Senators. Your voice may have prevented the Senate from moving forward on this vote.

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NY Times and Washington Post Cover Bush Regulatory Amendments

Almost two weeks ago, President Bush amended the federal regulatory process in an attempt to delay regulations and take power out of Congress's hands. Now, the mainstream media has picked up the scent. A front page story in today's New York Times and a column in today's Washington Post both cover the story.

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EPA's Risky Business

The US Environmental Protection Agency (EPA) is close to finishing a revision on how EPA assesses risk for toxic substances, according to Inside EPA(subscription). The new framework would affect EPA's Integrated Risk Information System (IRIS) database. For years, IRIS has been a tool for regulators to determine the "human health effects that may result from exposure to various substances found in the environment." Now, EPA is bowing to pressure from the White House and the Pentagon by allowing other agencies to meddle in the risk assessment process. Under the new framework, some agencies would have the opportunity to voice concern before data is included in IRIS. If the substance in question is deemed “mission critical” the agency would be allowed to submit alternate data, and ”potentially alter the final risk number,” according to Inside EPA. Good grief! If this plan comes into fruition, it will likely have catastrophic effects on the quality and quantity of exposure information the public can access through IRIS. Agencies will be able to fiddle with data they don't like. Stay tuned to Reg Watch for more.

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White House Wants CAFE All to Its Self

The White House wants the Department of Transportation (DOT) to continue to regulate Corporate Average Fuel Economy (CAFE) standards, according to the online environmental news source Greenwire (subscription). With the House of Representatives set to hold a hearing on fuel standards — and even Sen. Ted Stevens opening his mind — the Bush administration is clearly getting nervous that Congress may supersede Executive regulations. The White House wants DOT to continue to be a roadblock in the way of sensible fuel standards; and wants CAFE reform to sink in a regulatory quagmire. Jim Connaughton, the White House's chairman of the Council on Environmental Quality, doesn't think Congress should serve its Constitutionally provided role of protecting the public: "We don't support Congress picking the numbers because Congress doesn't have the technical infrastructure to do the analysis necessary to do it in a way that will save lives and make sure we're preserving good jobs in America." The White House position is not surprising, considering recent changes to the federal rulemaking process that place corporate interests above the public interest. Congress should ignore the White House, and provide legislation for cleaner vehicles across the nation.

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Oversight of Tobacco Will Be Pushed by Kennedy

The New York Times and Washington Post report today that Sen. Ted Kennedy will reintroduce legislation calling for regulation of the tobacco industry. Kennedy first introduced the bill in 2004 when it was passed by the Senate but stalled in the House. The bill proposes to place tobacco industry — which for years has been largely unregulated — within the regulatory view of the Food and Drug Administration (FDA). The FDA would be able to have a say in advertising, packaging, and content, according to the Washington Post. The rise in attention to this issue comes in response to a Harvard study concluding nicotine levels have been steadily rising in cigarettes. This bill is a common sense approach to regulating a dangerous product; and should be considered reasonable by all parties, even tobacco farmers, who will be offered hefty compensation. It is a measure that lawmakers on both sides of the aisle should ardently support.

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President Bush's Changes to Rulemaking Process Undermine Public Protections

Read OMB Watch's preliminary analysis here.

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