FDA establishes offices abroad to monitor products headed to U.S.
BEIJING The almost ubiquitous “Made in China” label has lost the confidence of many consumers over the last couple of years as hundreds of people and animals have become sick and died from Chinese products contaminated with chemicals.
Supplies of the blood-thinning drug heparin have come under particular scrutiny as almost 250 people have died and hundreds more have become sick after taking contaminated doses of the drug. On Nov. 6, the Food and Drug Administration seized 11 lots of heparin from Cincinnati-based Celsus Labs. The lots, manufactured from material imported from China, contained over-sulfated chondroitin sulfate, a contaminant that mimics heparin’s blood-thinning activity. Injection with heparin containing OSCS has been linked to several adverse reactions, including deaths.
To address the increasing risk of importation of contaminated food and drug products into the United States, the FDA has set up overseas offices in several countries, including three in China that opened last month.
The offices, in Beijing, Shanghai and Guangzhou, will analyze and examine products before their export to the U.S. The Department of Health and Human Services said they were part of an ongoing strategy to improve import safeguards to meet the changing demands of a global economy. HHS secretary Mike Leavitt and FDA commissioner Andrew von Eschenbach traveled to the three cities to meet with manufacturers and Chinese government officials to discuss policy and governance reforms for improving food and drug safety, as well as attending the offices’ grand openings and introducing officials who would work in them.
“A permanent FDA presence in China will help us address the challenges presented by globalization,” von Eschenbach said in a statement last month. “We look forward to working with the Chinese government and manufacturers to ensure that FDA standards for safety and manufacturing quality are met before products ship to the United States.”
The FDA is setting up similar offices in India, Latin America, the Middle East and Europe. The Beijing office is on the grounds of the U.S. Embassy; the Guangzhou office is at the Consulate General; and the Shanghai office is in the Shanghai Centre, a business complex that is also home to other U.S. government offices.
Drug inspectors receive Aleong National Patient Safety Award
FT. LAUDERDALE, Fla. Two drug inspectors in Florida have received the first annual Stephanie F. Aleong, J.D., National Patient Safety Award from Nova Southeastern University.
NSU announced that Brand Institute president and chief executive officer James Dettore and NSU dean Andres Malave presented the award last month to Gene Odin and Cesar Arias, two state drug inspectors who worked on a task force to investigate pharmaceutical drug abuse with Aleong, a prosecutor and NSU law professor who died in October.
The work of Aleong and the two inspectors resulted in counterfeiters of drugs for cancer, cholesterol, HIV and organ transplants being imprisoned, the university said.
Study results show Lipitor helps reduce rate of heart-health emergencies
NEW YORK Results of an observational study indicate that patients taking Pfizer’s Lipitor (atorvastatin calcium) had a 13 percent reduction in the relative risk of heart-related emergencies compared to Merck’s Zocor (simvastatin), drug maker Pfizer said Wednesday.
The study, published in the December issue of Mayo Clinic Proceedings, was based on the managed care claims of patients between 18 and 64. The patients had recently begun using the drugs, had not used statins before and did not have evident cardiovascular disease. The average doses in the study were 29 mg of Zocor and 17 mg of Lipitor. It did not find any significant difference among patients with the secondary endpoints of stroke, revascularization surgery or peripheral vascular disease.
“Observational data such as this, which reflect the use of medicines in real-world clinical practice rather than in a controlled trial setting, mayhelp healthcare providers and managed care companies improve clinical outcomes for patients,” Emory University medicine professor and director of the health promotion and disease prevention office at Grady Health Systems Terry Jacobson said in a statement.
The study analyzed claims for statin prescriptions filed between January 2003 and December 2005 by patients having their first inpatient or emergency room admission for heart disease, heart attack, chest pain, certain heart surgeries, peripheral vascular disease, swelling of the aorta, stroke and transient ischemic attack.