The CBS 60 minutes story by Dr. Sanjay Gupta had my attention when it mentioned the Heparin case and FDA Commissioner Margaret Hamburg admitted that 80% of active ingredients in US Pharma production are imported from countries like China,India and others. For three years the Heparin contamination matter is unresolved as the US-FDA and their understaffed Chinese counterparts try to track down the active ingredient suppliers. The House Energy and Commerce Committee is currently investigating.
It appears, that the contamination in the active ingredient was a cost cutting measure by the Chinese supplier. The ingredient must have passed the quality inspection, but guess what ? The adulteration is all about passing the inspection test with toxic substitutes and a total disregard for patient problems down the line.
Let’s think about this a little bit. The US Pharma industry is importing an incredible 80% of the active ingredients. The active ingredient is the chemical that is the one that does the treatment. If you remove the active ingredient, the drug should have no effect but here when the active ingredient is adulterated with a cheaper toxic substitute that passes lab tests, the patient is in very serious trouble.
Pharma company supply chain and finance managers feel great at the savings in imports, little realizing the ground realities in the foreign country. The exporter to the US is only trying to compete without ethics, and is able to evade the local lax regulatory regime and slow legal process. So what is the solution?
A two pronged approach is necessary. If possible – source the active ingredients in the US at least for life saving medicines. It’s good for the economy and well – for US public health!
Where active ingredients are imported just inspection of the foreign plant is not enough and neither is the receiving inspection test. It is probably important to have a formulated product test in place for imports. Wonder if all these checks will still make imports competitive ?