Washington Post on Industry Financing of FDA

In today's Washington Post, regulatory policy columnist Cindy Skrzycki has a piece on FDA user-fees — money pharmaceutical companies pay so that FDA can conduct safety studies on specific drugs. The column discusses the upcoming reauthorization of the Prescription Drug User Fee Act, as well as FDA's growing penchant for using industry money to fund agency activities. Check it out here.

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Supreme Court Says CO2 Should Be Regulated

The Clean Air Act is clear in stating the federal government should reduce the presence of harmful air pollutants. However, for years the Bush administration has ignored one of America's premiere environmental laws and failed to address perhaps the world's most harmful emissions: greenhouse gases. Today, the Supreme Court set the record straight. In what will surely be hailed as a landmark decision, the court ruled 5-4 the federal government can regulate greenhouse gas emissions. The ruling comes at an ideal time, as Congress and the American people are realizing the time to combat global climate change has arrived. Moreover, it proves the virtue of checks and balances in our democracy, as the Supreme Court has checked the Bush administration's failure to execute its constitutionally charged duties. For more from the Natural Resources Defense Council, click here. For background on the court case, click here.

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EPA Gets Cozy with Industry Once Again

EPA has finalized a new rule on soot that is a hand-out to the power industry. The rule will allow utilities to buy their way out of installing the latest and most effective technology for controlling soot emissions. Get the full scoop from Clean Air Watch's Blog for Clean Air.

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Interior Department Gets in on the Scientific Manipulation Fun

The New York Times reports this morning that an Interior Department manager has been ignoring science to pursue a political agenda. Julie A. MacDonald, the deputy assistant secretary for fish, wildlife and parks, became the subject of an agency Inspector General investigation after repeated complaints by employees: Ms. MacDonald, an engineer by training, has provoked complaints from some wildlife biologists and lawyers in the agency for aggressive advocacy for industries' views of the science that underlies agency decisions. The words of more than a dozen high-ranking career employees … describe a manager determined to see that agency findings and the underlying science conform with policy goals. The article points out MacDonald's reckless actions make many agency decisions overly vulnerable to legal challenges. "Making decisions that are vulnerable increases the risk that time-consuming, labor-intensive scientific and regulatory work must be redone."

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More OMB Manipulation of Climate Science

As Reg•Watch blogged earlier, the Government Accountability Project released a report detailing Bush administration political interference in climate science. The report includes evidence of manipulation by OMB. For example, the U.S. Climate Change Science Program (CCSP) is supposed to be a clearinghouse for accurate and up-to-date climate science produced by agencies. Unfortunately for the American people, OMB is one of the overseers of CCSP. According to the GAP report, OMB and other political offices sit on a panel that must approve CCSP communications. The panel has approved startlingly little information. It is worth noting that since 2004, CCSP has cautiously produced and posted on its website only five fact sheets and two research summaries, all ranging from two to four pages in length. It issued eight press releases — three of which were administrative announcements — and held one workshop on November 14-16, 2005. Furthermore, with the exception of three press releases, CCSP has not produced any new material as of January 2006. That's not much product from a staff of 14. (Current staff-level according to CCSP website).

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OMB Manipulates Climate Science Communication

Yesterday, the Government Accountability Project (GAP) released a report on the organization's year-long investigation into political manipulation of federal climate science. The report focuses on how Bush administration politicos interfere in climate scientists' communications with the media and Congress. The report accuses OMB of participating in the manipulation. In one instance, the National Oceanic and Atmospheric Administration was preparing formal responses to questions posed during a Senate hearing on climate change. OMB reviewed the draft and inserted text which "attributed global warming to increasing water vapor, in reliance on a quote taken out of context from a scientific paper." The text was finally removed, but not until the paper's author intervened. Water vapor?!? That kind of logic wouldn't fly in a junior-high earth science class, let alone the United States Senate. Stay tuned as Reg•Watch posts more examples of OMB interference uncovered in GAP's eye-opening report.

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Dudley May Return to the Hill for Confirmation Hearing

OMB Watch has learned a Senate panel may formally reconsider the long dormant nomination of Susan Dudley to become the White House's regulatory czar. Dudley — whose 2006 nomination stalled in the Senate Homeland Security and Government Affairs Committee (HSGAC) — could reappear before that committee if Chairman Joe Lieberman (I-CT) pushes forward. In 2006, President Bush nominated Dudley to be administrator of the Office of Information and Regulatory Affairs (OIRA) within OMB. Dudley blindly opposes any form of government regulation regardless of its potential benefit to society, thus making her an illogical choice to head the office which reviews the rules agencies develop. Because of this, public interest groups opposed Dudley's nomination, and a Republican-controlled HSGAC did not think it a high enough priority to address last fall. Never to be discouraged by the opinion of the people he governs, Bush renominated Dudley in January. A day later, Bush named Dudley a senior advisor in OIRA. If HSGAC decides to reexamine Dudley's record, we certainly hope they will realize she is not fit for the position and reject her nomination. If not, we expect Bush to appoint her during a Congressional recess this year. Stay tuned to Reg•Watch for more. For the full story on Dudley, check out Public Citizen and OMB Watch's report The Cost Is Too High.

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NY Times on FDA Conflict-of-Interest Proposal

The New York Times has a nice editorial about FDA's new proposal to reduce conflicts of interest on agency advisory committees. (See Reg•Watch's dissection from yesterday.) Read the editorial here.

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Markey Speaks out on Fuel Economy

Grist, an environmental news and commentary website, has conducted an interesting interview with Rep. Ed Markey (D-MA). Among other issues, Markey addresses his proposal to raise CAFE standards — the federal rule that governs passenger vehicle fuel efficiency. Markey discusses the prospects for passage of his bill, and ties President Bush's failure to strengthen American fuel economy to his failed Iraq strategy. Better Off Ed, from Grist.

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Scrutinize the FDA Day!

Reg•Watch is retroactively declaring March 22, 2007 Scrutinize the FDA Day (see below). Here's one more bit of news before this soon-to-be widely celebrated holiday comes to a close. This morning, the House Energy and Commerce Committee subcommittee on Oversight and Investigations held its second hearing on the FDA drug approval process. Panel Democrats grilled FDA commissioner Andrew von Eschenbach on how the agency has become powerless in regulating drugs, especially after they reach the market. Committee Chairman John Dingell (D-MI) repeatedly criticized the culture at FDA as a contributing factor. OMB Watch has reported on the increasing need for reform in the agency's drug approval process. The hearing also featured testimony from Marcia Crosse — not the desperate housewife, but the Government Accountability Office director for health care. Crosse's testimony pointed out FDA has begun initiatives to correct some of the problems detailed in a 2006 GAO report, but it is too soon to tell how effective those reforms will be. Also of note, at least one lawmaker, Rep. Jan Schakowsky (D-IL) mentioned FDA's new guidance on advisory members which Reg•Watch mentioned earlier today.

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