› $4.85 Billion settlement in drug case
Lawmakers’ concern over the U.S. becoming too reliant on foreign countries to produce drugs are calling for a rule to require certain drugs to be made or stockpiled in the U.S., according to the New York Times. The Times quotes Sen. Sherrod Brown of Ohio as saying that relying on other countries to produce our country’s medicines opens the door to “supply disruptions, counterfeit medicines, even bio-terrorism.”
In an ongoing effort to ensure the safety of foods and drugs imported to the United States, the FDA is opening offices in foreign countries to oversee quality control of those products. The agency announced this week that it has opened two offices in India, according to Med Page Today.
The New England Journal of Medicine reported that the Centers for Disease Control and Prevention (CDC) in a study titled “Outbreak of Adverse Reactions Associated with Contaminated Heparin,” has confirmed the cause of serious adverse reactions in late 2007 were due to heparin contaminated with oversulfated chondroitin sulfate (OSCS). In the study, the CDC also determined that the contaminated heparin was linked to 152 adverse reactions in 113 patients from 13 states from Nov. 19, 2007 through Jan. 31, 2008.
A team of researchers from the Massachusetts Institute of Technology (MIT) has confirmed that over-sulfated chondroitin sulfate was, in fact, the contaminant in heparin that was manufactured in China and triggered serious allergic reactions that caused more than 80 Americans to die and hundreds more to be sickened earlier this year, according to ABC Action News.
Researchers have come up with an easy and effective method to detect contaminates in heparin, according to the Times of the Internet. A research team led from the University of Michigan and led by Mark Meyerhoff uses potentiometric polyanion sensors to detect heparin in blood. These sensors also can be used to distinguish pure heparin from heparin contaminated with small quantities of oversulfated chondroitin sulfate.
