Summary
In his tightly packed federal budget proposal that calls for deep cuts to many government programs, President Bush asks for a 24 percent funding increase for drug monitoring. Bush cites last year's problems with Vioxx as the main sign the Food and Drug Administration needs more money. FDA officials are still dealing with the consequences of originally approving the arthritis painkiller that was eventually pulled from the market after links to heart attacks were discovered.
Original source:
http://www.reuters.com/newsArticle.jhtml?type=healthNews&storyID=7560923
Details
- The Bush administration proposed on Monday a 24 percent increase in funding for the Food and Drug Administration office that monitors the safety of drugs after they hit the market.
- The proposal follows last year's withdrawal of a well-known painkiller and charges that the FDA pays too little attention to serious side effects that emerge after drugs win approval.
- The additional $6.5 million would be used in part to hire 25 more employees for the Office of Drug Safety, Kathy Heuer, the FDA's chief financial officer, said in an interview.
- About $1.5 million of the new money would come from congressionally mandated industry user fees, which pharmaceutical companies pay in exchange for faster reviews of their products.
- This money would be used to hire five of the new reviewers, Heuer said.
- The increased funding was part of President Bush's proposed budget for fiscal 2006, which starts Oct. 1.
- The drug safety office came under scrutiny last year when a veteran scientist said his FDA supervisors ignored or downplayed his warnings about risks of Merck & Co. Inc.'s arthritis drug Vioxx.
- Charles Grassley, who held a pivotal hearing in November over Vioxx's withdrawal, said he would still push for greater independence for the safety office.
- "In addition to more resources, I want to make sure the drug safety office gains independence from the office of new drugs," said Grassley, an Iowa Republican.
- Bush budget papers said the added money for the safety office would also fund access to a range of databases to help scientists spot potential problems with prescription drugs.
- Overall, the FDA budget would increase by $81 million to $1.9 billion in fiscal 2006 under Bush's plan.
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