Bush Budget Would Reduce Funding for FDA Safety Inspections of Foreign Drug Plants

Main Category: HIV / AIDS
Article Date: 17 Feb 2005 - 3:00 PDT

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The fiscal year 2006 budget proposal released last week by President Bush would reduce funds for almost all.... FDA inspection programs, such as those that review imported foods and prescription drug manufacturing facilities abroad, USA Today reports. Under the budget proposal, the number of U.S. food safety inspections made next year would decrease by 5% from this year's estimate, the number of inspections of prescription drug manufacturing facilities abroad would decrease by 5.8% and the number of inspections of U.S. blood banks would decrease by 4.7%. Some experts have raised concerns that a reduction in FDA inspections could leave the United States more vulnerable to counterfeit prescription drugs or improperly manufactured products. "We don't want to end up with a buyer-beware market for necessary medicines," according to Sarah Sellers, an FDA adviser, pharmacist and medication safety expert. In a statement, FDA officials said that the agency would focus inspections on areas with the highest risks. "Intelligent, risk-based inspections are more important than absolute numbers of inspections. (The agency) is committed to carrying out our mandate of promoting and protecting the public health," the statement said. Bush proposed the reduction in funds for FDA inspections "amid criticism the FDA failed to inspect often enough a long-troubled British vaccine plant that the United States had counted on for half of its flu vaccine supply," USA Today reports. In response, FDA officials have said that the agency will begin to inspect vaccine manufacturing facilities every year, rather than every two years as required by law (Appleby, USA Today, 2/15).

Obama Calls for More Funds for VA Health Care
In other budget news, Sen. Barack Obama (D-Ill.) on Monday said that the Department of Veterans Affairs requires at least $4 billion more than Bush requested in his budget proposal to ensure adequate health care and disability payments for veterans, the Chicago Sun-Times reports (Reed, Chicago Sun-Times, 2/15). The budget proposal would require about two million higher-income veterans without service-related conditions to pay a $250 annual fee, as well as an $8 increase in copayments for prescription drugs, for FY 2006. Under the proposal, total funds for VA would increase to $68.2 billion, or by 1%. The budget proposal would eliminate federal funds for a program that provides long-term care for veterans and reduce funds for VA nursing home care by $351 million, which could lead to the elimination of about 5,000 nursing home beds administered by the department (Kaiser Daily Health Policy Report, 2/11). At a press conference in Chicago, Obama, a member of the Senate Veterans' Affairs Committee, called Bush "bull-headed" and said that the budget proposal does not consider increased demand from veterans who return from Iraq. "When you adjust for inflation, the president's budget has even less money for veterans than it had a year ago," Obama said, adding, "We have a tendency to applaud our Armed Forces when they are overseas and in uniform and have a tendency to forget about them when they come home" (Chicago Sun-Times, 2/15). The Senate Veterans' Affairs Committee plans to address the budget proposal on Tuesday, and the House Veterans' Affairs Committee plans to consider the proposal on Wednesday ( Cobb, Houston Chronicle, 2/15).

"Reprinted with permission from kaisernetwork.org kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

Article adapted by Medical News Today from original press release.
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Visitor Opinions (latest shown first)

FDA Quality Control Of Foreign Drugs Brought Into USA.

posted by Gary on 22 Jan 2008 at 5:08 am

I have worked in quality of a major automobile manufacturing company and this is what is the guidelines for exporting product from foreign manufacturing facilities.
1. Quality control liability lies with the exporter...
2. Quality of the base materials are certified
3. Quality of manufacturing method and production run is certified before the 1st. shipment
4. Production run sent to FDA for approval...
5. FDA approval then exporting begins and random sample of quality exporter and FDA.
This would be my method of safety for the protection of the consumer...

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