Schedule a Consultation | Toll Free: 1-800-678-1307
Trial lawyers specializing in personal injury and civil litigation

The risks entailed in moving our entire drug manufacturing business abroad

The media has done a good job of documenting the health risks associated with purchasing products from the third-world, where they are usually not manufactured to American standards.  That risk has been particularly great in the case of drug manufacturing, since the FDA regularly inspects and investigates domestic manufacturers, but no one insures similar compliance in many foreign countries.  The result has been a dramatic cost savings associated with manufacturing drugs in India or China [at least to manufacturers, if not to consumers or the government], and in the past few years a tsunami of unsafe or contaminated product recalls, including, for example Heparin.

This on-going issue has been addressed previously in this web log, however, little attention has been paid to a related danger associated with the emigration of drug manufacturing:  how safe is our drug supply, not from tampering or contamination, but rather in the event of political upheaval?  Can we really object to Chinese currency manipulation, for example, if we have no other source for numerous essential, life-saving medications?  If Indian authorities become upset over American foreign policy or we object to India's response to the "war on terror", can India blackmail us by denying us essential medicines?  At what point could we be held hostage to our need for antibiotics, blood thinners, or vaccines, for example?  Right now, we have no source other than China or India for prednisone, metformin, amlodipine and numerous other crucial medications for treating, respectively, allergies, diabertes and high blood pressure. 

The generic drug applications on file with the FDA in 2007, list 1200 plant locations:   according to the New York Times, 43 percent of the plants are in China, 39 percent are in India, and 13 percent were in the U.S.  This is not simply a massive loss of American jobs:  it represents a loss of security and sovereignty, as well.  Just as Germany's foreign policy is complicated by its reliance on Soviet oil, our foreign policy is progressively complicated to a greater degree by our reliance on foreign manufacturers.  Some commentators expect the new Obama administration to crack down on abusive Chinese trade policies:  can our government even consider that possibility if China has the power to cut off our access to key exports such as life-sustaining medications?

In the case of a pandemic, or a chemical or biological attack, would we be able to procure adequate supplies of medicine to protect 300 million Americans, if the American stockpile, for example in the case of flu vaccine, is less than 50 million doses?  Could we protect our citizens if trade with other nations is disrupted by quarantine rules?  It is widely believed that most victims of the 1918 flu pandemic died of bacterial infection, not the flu virus:  would we have access to an adequate supply of penicillin products if we don't make penicillin [we don't]  and other nations elect to protect their own population?  Most experts agree that it would take about two years to build an adequate manufacturing base for most essential medications, if our supply was disrupted:  do we feel comfortable putting our health at risk in this way, in order to save a few pennies on the manufacture of these drugs? (Not to mention the fact that these savings are all too often inuring only to the benefit of manufacturers and are not reflected in the price to consumers).

When a Madison, Wisconsin firm recently poisoned a number of patients with contaminated Heparin, the FDA pounced to shut it down.  The joke was on us, however.  The only other supplier of heparin to the U.S. also procures its heparin components from China.  Our prompt safety response did little beyond changing the name on the label of the medicine.  We are mortgaging our independence and our health in the name of reduced labor costs.  Are we getting enough for our money?

Thompson O’Neil, P.C.
309 East Front Street
Traverse City, Michigan 49684
Toll Free: 1-800-678-1307
Fax: 231-929-7262