Dr. Patrick Soon-Shiong, a billionaire pharmaceutical executive from American Pharmaceutical Partners (APP), is calling for the pharmaceutical industry to reform how it polices its products. He argues these companies must take a larger role in insuring the safety of their products since the Food and Drug Administration (FDA) is so overwhelmed. Dr. Soon-Shiong is speaking so freely about this issue after he and his company, APP, stepped in during the heparin crisis, providing a large, safe supply of the drug. Without this aid, many Americans may have suffered. Heparin is a blood thinner used daily in hospital surgeries and for kidney dialysis patients. This major drug, one of the most used in America, fell into jeopardy last winter when it was found to be contaminated by an ingredient that was not accurately monitored by the FDA and the pharmaceutical companies themselves. It is believed that this contaminated drug led to at least fifty-five deaths, though the FDA has only been able to find a link between the drug and three deaths. http://abcnews.go.com/print?id=5441082
Leroy Hubey claims both his wife and son died after taking the contaminated heparin. Investigations into both of these deaths pointed to China, the place where the raw ingredients for heparin originate. The FDA concluded someone at the Chinese manufacturer spiked the crude heparin with a counterfeit similar looking drug to increase profit. Unfortunately, heparin is not the only drug that is manufactured overseas. About eighty percent of all the raw ingredients in American drugs come from foreign countries. Former FDA commissioner William Hubberd contends there will be more drugs that will become contaminated, like heparin, until someone fixes the problem. This is a major reason Soon-Shiong is calling for reform. For example, he wants the process of heparin, which uses pig product as an active ingredient, to be regulated from the health and welfare of the live pig all the way to the slaughterhouse and the finalized heparin itself.
Current FDA commissioner Janet Woodcock states the FDA is looking more closely at products that are produced in foreign countries, however, because the agency is underfunded and understaffed, it cannot safeguard Americans as well as it would like. She said the agency can only inspect about one-percent of imported food and drugs, and can hardly inspect any foreign drug manufacturers because it does not have the staff to do so. This effectively leaves pharmaceutical plants alone to police themselves. Baxter, the manufacturer of heparin, claims there was not a test it could have conducted that would have shown the contamination in the drug. Leroy Hubey, however, disagrees and is suing the manufacturer for wrongful death. Dr. Shiong agrees, claiming the company could have caught the problem early on in the supply chain. http://abcnews.go.com/print?id=5441082