Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

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.

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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.

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The tainted heparin scandal was listed as the No. 1 story in the Chicago Tribune’s “The Top 10 local business stories of 2008.”

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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.

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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.

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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.

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Rep. Joe Barton, a ranking member of the House Energy and Commerce Committee, appears to be fed up with the FDA’s reluctance to provide details of the tainted heparin scandal that first came into public light earlier this year, according to CNN Money. That scandal resulted in the deaths of more than 80 Americans and adverse reactions in hundreds more, and led to an agency recall of lots of the blood thinner manufactured in Baxter International’s Chinese facility.

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The Associated Press reported today that Food and Drug Administration Commissioner Dr. Andrew von Eschenbach will resign from his post effective Jan. 20, the same day president-elect Barack Obama takes office.

Von Eschenbach was appointed by President Bush in 2005 after the agency’s previous commissioner resigned due to ethical issues, the AP reports. While under von Eschenbach’s helm, the FDA has undergone scrutiny by Congress and consumer groups over issues such as the tainted heparin scandal earlier this year.

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A Texas congressman is questioning why the FDA waited six months to seize lots of contaminated heparin from an Ohio company, according to CNN Money.

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A Washington lawmaker is raising concerns about the FDA’s handling of the tainted heparin scandal earlier this year, claiming that the agency misrepresented deaths tied to the product and didn’t thoroughly investigate the situation, according to CNN Money.

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