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FDA Product Safety Initiative Gets $166 Million In FY ’10 Budget Proposal

Executive Summary

A $166 million initiative aimed at ensuring supply chain safety and security for medical products is part of the $3.2 billion fiscal year 2010 FDA budget proposed by the Obama administration

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FDA Legislative Updates, In Brief

Pandemic flu: Federal preparations for and response to the H1N1 flu outbreak is funded with $7.7 billion in the 2009 supplemental appropriations bill approved by House and Senate conferees June 11. The funds are allotted to HHS, but most - $5.8 billion - will be available only on a contingency basis for critical needs. The remaining $1.85 billion, the amount provided by the original House bill and $350 million more than by the Senate bill, will be immediately available. Bill language has not been released yet, but a House staffer said the money will be divvied up according to earlier House language, which allowed financing of private vaccine production facility construction or rehabilitation (1"The Pink Sheet," May 25, 2009, p. 32). The White House requested the contingency funds June 2; final House and Senate approval on the consensus measure is expected shortly. The agreement came the same day as the World Health Organization announced that the spread of the H1N1 virus meets criteria for an influenza pandemic

FDA Legislative Updates, In Brief

Pandemic flu: Federal preparations for and response to the H1N1 flu outbreak is funded with $7.7 billion in the 2009 supplemental appropriations bill approved by House and Senate conferees June 11. The funds are allotted to HHS, but most - $5.8 billion - will be available only on a contingency basis for critical needs. The remaining $1.85 billion, the amount provided by the original House bill and $350 million more than by the Senate bill, will be immediately available. Bill language has not been released yet, but a House staffer said the money will be divvied up according to earlier House language, which allowed financing of private vaccine production facility construction or rehabilitation (1"The Pink Sheet," May 25, 2009, p. 32). The White House requested the contingency funds June 2; final House and Senate approval on the consensus measure is expected shortly. The agreement came the same day as the World Health Organization announced that the spread of the H1N1 virus meets criteria for an influenza pandemic

Generic Drug Fees In, DTC Fees Dropped, From Obama Budget Proposal

Some of FDA's funding increase promised in President Obama's budget comes from user fees which would have to be established legislatively - meaning that the administration will have to negotiate with industry and congressional authorizing committees, not just House and Senate appropriators, in order to see its vision enacted

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