China Plant Played Role

Recent documented quality issues of imported consumer products from China, highlights shortcomings in the China State Food and Drug Administration's (SFDA) regulation of China producers.   This article brings light on deficiencies of the US FDA's framework on oversight for non-US producers of API used for drugs usage in the US.  It's arguable that in light of increased recent meetings between...

      I see two ways for FDA to regulate drugs.  -To enforce the import of drugs or active ingredients only from the  manufacturers that can be inspected and certified by FDA. This will mean more agents and higher cost of running the agency by federal government. Some of this cost should be shared by pharmaceutical manufacturers to justify the high...

Heparin is used daily in veterinary hospitals for both small animal (cat, dog) and large animal (horse, cow) patients.  It will be hard to determine the effect it had on our veterinary patients.  Heparin is a critical part of daily veterinary practice.

Although patient deaths are of grave concern, the impact of a heparin shortage stand to put around 400,000 US dialysis patients at risk.  Heparin is the "oil of hemodialysis" and without it, hemodialysis would come to a standstill. There are alternatives available, such as Andiomax and Lovenox, however, they are not practical for the hemodialysis community owing to the fact that they do not have...

1:Most of our legislators are forcefully endorsing generic drug usage and importing cheaper drugs.2:As a physician specialist in Clinical Pharmacologist I am fully aware or the safety and efficacy pitfalls of poorly manufactured  drugs and have done clinical research documenting the risks of patients treated with them.3:For that reason I strongly advised my patients to buy branded drugs by reputable...

The FDA is under extreme pressure as a result of the never ending disclosure of multiple problems, particularly the the risk of death from tainted pharmaceuticals obtained from China.  As the article discloses, China has become the number one provider of ingredients of substantial amounts of the drugs that Americans consume.  Unfortunately, the government has left the FDA with limited resources...

The trend to utilize raw materials manufacturers outside the US is driven by dramatic cost savings and is certainly still rising.  Chemistry controls should be specifically targeted to identify impurity profiles in the receipt and release testing of imported material.  FDA could become more conservative with respect to analytical specifications for imported material but is unlikely to staff...

The Food and Drug Agency (FDA) of the United States may not be trained, staffed, or budgeted to oversee medicinal production overseas. The World Health Organization (WHO) with Food and Agriculture Organization (FAO) formed a Global Food Standards body, Codex Alimentarius to have oversight on what and how nutrition standards for the human population could be best met. Their standards,...