› $4.85 Billion settlement in drug case
FDA chief scientist and principal deputy commissioner Dr. Frank Torti will serve as the agency’s acting commissioner when Dr. Anderew Von Eschenbach leaves office this week, a position he will hold until the Obama administration appoints a new leader and the Senate approves the choice, according to Scrip World Pharmaceutical News.
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.
The FDA announced today that it will launch a voluntary two-year pilot program to help promote the safety of drugs and active drug ingredients made outside the U.S. As part of the Secure Supply Chain program, the FDA will select 100 volunteers to maintain control over drug products beginning with when they are produced until it enters the U.S.
Actor Dennis Quaid and his wife Kimberly now have closure in their year-long heparin overdose lawsuit against Cedars-Siani Medical Center, according to OK! and Entertainment Tonight. The entertainment media reported that a Los Angeles judge has signed off on the $750,000 settlement the couple reached with Cedars-Siani last month. According to the settlement, the hospital did not admit wrongdoing in the potentially fatal overdose of heparin that was accidentally administered to the couple’s newborn children Zoe Grace and Thomas Boone Quaid. The settle also allows for the couple to pursue claims for their children in the future. The California Department of Public Heath fined Cedars-Siani $25,000 for the error.
A class action lawsuit has been filed against Baxter Healthcare Corp., claiming the company began substituting ingredients in its anti-coagulant heparin with a dangerous counterfeit to “reap greater profits as a result of utilizing cheap component parts,” according to The Madison St. Clair (Illinois) The Record.
The tainted heparin scandal was listed as the No. 1 story in the Chicago Tribune’s “The Top 10 local business stories of 2008.”
The National Academies of Sciences Institute of Medicine, the Consumer Federation of America and the Center for Science in the Public Interest have joined together to urge the incoming Obama administration to address food safety issues that have plagued the FDA in the past few years. However, the Institute of Medicine and the consumer groups disagree on the legalities, according to Flesh and Stone.
Rhodia SA, a leading producer of paracentamol drugs Panadol and Tylenol, will close its factory in France this week, leaving Europe completely dependent on imports for that drug, according to Bloomberg. Rhodia says it is dropping out of the $800 million paracentamol business because of stiff competition from Asian producers who can export the same product at a fraction of the cost.
New blood-thinning medicines are in the works and to offer doctors more options in treatment and prevention of blood clots, according to Bloomberg. Bloomberg reports that at least six companies are working on blood thinners to take advantage of a growing need. According to Datamonitor, a London-based research company, the anticoagulation drug market is expected to reach $20 million by 2012.
An infant may have been among the victims of the tainted heparin scandal earlier this year, according to WorldFocus consultant Peter Eisner, who has reported on the heparin crisis over several months. Eisner reports that Julien, the son of Alex and Ann Oryschak, died Nov. 19, 2007, after becoming ill. The Oryschaks believe that heparin may have lead to their infant son’s untimely death, and they want to share their story in hopes of influencing changes in drug regulations.
