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Monday, July 30, 2007

Expert Urges FDA to Pull Diabetes Drug from Market

An FDA scientist has recommended the diabetes drug Avandia be pulled from the market for heightening heart attack risks associated with its use. Dr. David Graham made the recommendation during a meeting of a scientific advisory panel which will consider whether the drug should continue to carry FDA approval, according to the Associated Press.

In May, a study published in the New England Journal of Medicine called attention to heart problems associated with the drug.

The FDA could have prevented this scandal by listening to doctors and scientists who recommended a "black-box" warning on the drug's label, the highest the FDA imposes, in February 2006. Instead, the FDA chose to alienate its own experts from the process, siding with industry-backed data.

Unfortunately, patients who have taken Avandia bear the true cost of regulators' irresponsibility. GlaxoSmithKline is questioning the validity of FDA data with its own, also according to AP. Let's hope that this time FDA stands up for public health.



Posted by Kyle Hatzes, 11:52:12 AM



Tuesday, July 17, 2007

A Galling Example of White House Regulatory Delay

The White House Office of Information and Regulatory Affairs (OIRA) is sitting on a rule which would set speed limits for large shipping vessels traveling along the eastern seaboard during the migration season of the North Atlantic right whale. The standard would reduce the number of whales killed in collisions with ships.

Because the rule is considered "major," the National Oceanic and Atmospheric Administration (NOAA) submitted the rule to OIRA for the standard review period prescribed by Executive Order 12866.

OIRA received the rule on February 20, 2007. Under the E.O., OIRA is required to complete its review within 90 calendar days. In consultation with the issuing agency, OIRA may extend the review period once by up to 30 calendar days.

RegInfo.gov, the federal government's regulatory review database, acknowledges the review period for this rule has been extended. However, even with an extension, the review of the rule should have been completed by June 20.

In 2006, OIRA performed a similar review before NOAA published its proposal. This begs the question: If OIRA has already reviewed and edited this rule, why is it continuing to delay finalization? The answer: Delaying the publication of this rule benefits industry.

As the public interest group Public Employees for Environmental Responsibility points out, the shipping industry has been lobbying vigorously against this rule. Unfortunately for industry lobbyists, NOAA has been working on the rule for years and has built a rock solid case in support of it. Since this White House has such a penchant for catering to big business, the only option for OIRA and its new administrator, Susan Dudley, is to endlessly delay finalization of the rule — even if it is in violation of White House policy (the executive order).

Read more from Public Employees for Environmental Responsibility



Posted by Matt Madia, 01:41:10 PM



Tuesday, July 03, 2007

EPA Considers Industry Allies for Key Advisory Committee

Scientific advisory committees provide important, impartial advice on a wide range of issues. A committee's recommendations provide a strong analytical and scientific basis for agency rulemaking activity. EPA's Clean Air Scientific Advisory Committee (CASAC) is one of the federal government's most important.

As we've seen with EPA's ozone standard, when an advisory committee calls for a tighter standard, environmentalists and public health advocates are given a valuable piece of evidence in advocating for more protective regulation. That's a pesky problem for an administration which prefers environmental rollbacks to progressive protections.

One way to solve the problem is to stack scientific advisory committees with industry allies. EPA is considering for CASAC's particulate matter unit a number of scientists who have been vocal in doubting the relationship between particulate matter exposure and adverse health effects. Not surprisingly, those scientists have also taken money from the energy industry.

GoozNews has more on this issue and descriptions of two nominees with dubious records.



Posted by Matt Madia, 04:16:28 PM




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