FDA em crise. Quem vigiará as grandes empresas

Sen Arlen Specter (R, Pa) said the White House is delaying the swift provision of an additional $275 million to the US Food and Drug Administration (FDA) by requesting that the funds be included in the fiscal year 2009 budget rather than the FDA’s current budget. The money is intended to help the agency protect the nation’s food supply, ensure safer drugs, and modernize its facilities.

Specter said he had worked to get the FDA an additional $275 million in the Senate version of the fiscal year 2008 supplemental appropriations bill, which, if approved, would provide the funds to the agency no later than September 30. In a June 10 letter to Michael Leavitt, secretary of the Department of Health and Human Services, Specter wrote that the Bush administration’s request is “drastically hindering necessary immediate relief” because the additional funding would not be provided until March or April 2009.

“The 81 deaths due to contaminated heparin and the 1 suspected death in the ongoing Salmonella outbreak show that we cannot wait 9 months to give the FDA the resources needed to protect the public,” Specter wrote.

Mike Mitka

Dissecção da aorta vista por dois métodos complementares.

Panel A. Aortic dissection with a systolic flow in the true lumen (TL) of ascending aorta on TEE. A continual flow can be seen in the false lumen (FL) in which an intraluminal thrombus (T) is evident.

Panel B. A hypermobile double lobar thrombus connected to the penetration canal (P) heading to left atrial roof.

Panel C. Continuous turbulent jet heading from the aorto-left atrium fistula canal (P) to left atrial roof.

Panel D. Double intimal tear in descending aorta.

Panel E. A reconstructed three-dimensional CT image using volumetric rendering method. An evident aneurysmatic dissection of ascending aorta with a rupture of aortic adventitia and penetration into left atrium (arrow).

Panel F. An extensive thoracic aorta aneurysm dissection penetrating into left atrium. A tricuspid aortic valve (Ao), left ventricle (LV), and an intimal line (I) separating true aortic lumen (TL) from false lumen (FL) can also be noticed. Hypodense masses with an irregular margin lining the edges of a proximal part of a false lumen are thrombi (T) penetrating into the left atrium (LA).

Panel G. Short axis CT image of ascending and descending aorta.

Panel H. Distal part of dissection in area of right common iliac artery (white arrow).

Panel I. A view of a false lumen with a noticeable penetration opening into left atrium. The arrows are pointing towards its CT angiography and TEE correlates. The true aortic lumen is compressed by a suction tube.


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