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Chinese Firms Still Supplying Heparin to U.S.?
Two Chinese companies that were implicated in supplying contaminated ingredients three years ago to Baxter International Inc. for manufacturing heparin may still be supplying product to the U.S., according to reports. Heparin is given to about 12 million people in the U.S. each year. A Congressional committee began investigating contaminated heparin in February and expanded its investigation in May to seek information from U.S. Immigration and Customs Enforcement and from industry leaders in June.
http://www.businessweek.com/news/2011-10-26/chinese-firms-linked-to-tainted-heparin-still-supplying-u-s-.html
NIH Proposes to Help Eliminate Bottlenecks in the Drug Development Process
The statistics on drug development are no secret: for every 10,000 compounds discovered, only one gets approved, and it usually takes 14 years and $1.2 billion to reach the market. "Surely there must be bottlenecks that can be tackled," NIH Director Francis Collins said in a speech Monday at the AAPS annual meeting.
Collins said that his agency needs to take an engineering approach to eliminate anything that slows development. The approach would involve early discovery and preclinical development and identifying new targets for approved drugs or compounds abandoned in the clinical stage.
He proposes repurposing and rescuing drugs that are already known to be safe in humans (Editor's note: This appears to be similar to off-label uses of currently approved drugs.). The NIH has compiled a definitive list of approved drugs, providing researchers a resource for systematically looking for drugs that may be repurposed for other uses.
http://www.fiercepharma.com/story/collins-nih-targeting-bottlenecks-drug-development-process/2011-10-25
FDA Says "No" to Jet-Injector Administration of Flu Vaccines
The FDA has recommended against the use of "injector devices" to administer influenza vaccines. Just last month Bioject Medical Technologies of Portland, Oregon, announced that some Publix Super Markets and Fred Meyer Stores locations would offer needle-free flu vaccines to customers this flu season, courtesy of Bioject's gas-powered injector systems. Bioject states that the company has received FDA clearance to market two jet injectors for the subcutaneous or intramuscular delivery of vaccines and other injectable drugs. FDA has stated that people who have already received an influenza vaccine by jet injector do not need to be revaccinated.
http://www.ashp.org/menu/News/PharmacyNews/NewsArticle.aspx?id=3621
Scientists Say Suggested Mercury Ban Could Threaten Vaccines
Scientists have warned officials negotiating a global treaty on mercury that banning the deadly chemical completely would be dangerous because of the chemical's use (thiomersal, thimerosal) in vaccines.
The World Health Organization states that mercury is one of the top 10 chemicals of public health concern and is highly toxic. These worries are primarily centered on mercury emissions from burning coal, gold mining, and people eating mercury-tainted fish.
"Not being able to use mercury is not a viable option," said David Wood, a WHO vaccines expert." According to Wood, there isn't a viable alternative to thiomersal at the moment. If banned, preservative-free vaccines would be required. (Editor's Note: This would then require single-dose vials/amps and not multiple-dose vials.)
http://www.chicagotribune.com/news/nationworld/sns-ap-eu-med-mercury-ban,0,6884065.story
Moratoriums Not Being Used to Eliminate Medicare Fraud
Federal health officials have not imposed a single moratorium that would prevent potentially fraudulent Medicare providers from joining the program, Under the Affordable Care Act, the CMMS was granted broad power to impose moratoriums in regions where fraud is rampant or for certain types of providers such as medical equipment or home health care, sectors where billions of Medicare fraud dollars have been lost.
http://affiniscape.yellowbrix.com/api/?service=story&method=xml&id=affiniscape&story_id=165183337&source=Associated+Press%2FAP+Online
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