China strengthens safety regulations due to contamination in Heparin
SHANGHAI, China Baxter international has recalled all batches of Heparin, prompting China’s top drug safety agency to order its local bureaus to increase supervision over the manufacturing of the blood-thinning drug, according to the New York Times.
The use of heparin has resulted in about 19 deaths and hundreds of allergic reactions in America, and in Germany, Heparin, provided from another Chinese manufacturer, has also experienced a reported 80 accounts of allergic reactions.
According to the Times, China is the largest supplier of Heparin, and the Food and Drug Administration last week reported that active ingredients from Baxter’s Chinese supplier, Changzhou SPL, were contaminated with a cheaper version of Heparin.
China’s drug agency, the State Food and Drug Administration, has ordered that producers of the active ingredients of Heparin must get their raw materials from registered suppliers, and has strengthened the checks that the raw materials are safe and efficient. Investigations are still continuing on whether the fake material, which was identified as oversulfated chondoitin sulfate, caused the allergic reactions in patients.
The Times also reported that the FDA has ordered that all the imports of Heparin be inspected for contamination. It seems likely that the active ingredient would be contaminated, as much of the production of Heparin occurs in small factories and homes that are unlicensed and unregulated.
Based on the Chinese agency’s order, organizations involved in the health and drug industry are being pushed to create a system to be able to trace back to the raw materials used in order to prevent future health issues.
Canada court blocks sale of generic form of Lipitor
NEW YORK Canada’s appeals court ruled in favor of Pfizer not allowing Ranbaxy Labs to produce the generic version of the drug Lipitor, according to published reports.
The decision overturned a ruling made by lower courts that stated that the patent could not prohibit Ranbaxy from selling a cheaper version of Lipitor (atorvastin calcium), which is used to fight cholesterol.
The appeals court of Canada decided that Ranbaxy could manufacture its product as soon as Pfizer’s product expires in 2010, which leads many to believe that this decision will push Ranbaxy to take the matter to the Supreme Court of Canada.
McCain’s healthcare plan suggests a loss for pharmaceutical companies
WASHINGTON John McCain’s healthcare plan, with a call to purchase drugs in Canada, may cost American pharmaceutical companies billions of dollars, according to published reports.
According to McCain, the Republican presidential candidate, “The problem is not that most Americans lack adequate health insurance, the biggest problem with the American healthcare system is that it costs too much.”
McCain’s health policy would allow citizens to purchase medicines legally from Canada, which would make them more affordable for the reported 47 million Americans that don’t have health coverage.
According to published reports, such drugs as Pfizer’s Lipitor, known as the world’s biggest selling drug, costs $60.78 for a 30-day supply of 20 mg pills on CanadaDrugs.com, whereas Drugstore.com in the U.S. sells the same pill in the same amount for $119.99.
The new policy is predicted to cost drug makers—like Pfizer—about $40 billion over 10 years, according to a report by the Congressional Budget Office.