There’s a dangerous weak link in today’s medical system – abusive government regulatory meddling that has left us all with a frail and inefficient drug supply chain.
For a variety of reasons that we’ll outline in the next few minutes, the available quantity (and quality) of safe prescription drugs for Americans is at risk. What has been the main cause of this weakening drug supply chain? A lot of negative trends are in place so it’s difficult to narrow down to one specific cause.
Consider just one consequence of regulatory micromanagement: Pharmaceutical companies’ outsourcing key components of their operations (such as research and development, manufacturing and packaging) to foreign firms and domestic subcontractors. Although it’s less expensive to outsource than make large capital investments, reliability and quality control suffered along the way.
Here’s one example of how a vulnerable drug supply chain can affect American consumers. In 2008, the U.S. Center For Disease Control and Prevention (CDC) investigated incidents that occurred in November 2007. Dozens of Americans had adverse allergic reactions, which made some patients ill… and resulted in death for others.
Investigations linked these incidents to a contaminated intravenous version of the widely-used blood thinning drug Heparin. It was manufactured in China by Baxter Laboratories with oversulfated chondroitin (OSCS) used in place of the real drug. It’s significant because OSCS costs 100 times less to produce than authentic Heparin; and its characteristics are so similar that it was undetected in standard tests.
Counterfeit versions of Lipitor, Tamiflu and other pharmaceutical drugs come into the U.S. almost daily, mainly from China and India. But these fake drugs aren’t just limited to America or a few countries. Economist.com reported in October 2012 that 106 countries had found 60 fake versions of Pfizer drugs as of July 2012.
While generic drugs are less expensive and more plentiful, the occasional recall of generics can jeopardize the short-term supply. In November 2012, the Associated Press reported that India-based Ranbaxy Laboratories recalled dozens of lots of their generic version of Lipitor when glass particles were found in these lots. Ranbaxy has been investigated, suspended by the FDA from producing and distributing generic drugs (and later reinstated) since 2006.
The Food and Drug Administration (FDA) has estimated that 40% of all finished drugs used by American patients — and 80% of all ingredients that make up these drugs — are manufactured overseas. This outsourcing has made it difficult for the FDA to ensure the quality of prescription drugs.
In September 2011, Senate hearings were held on this agency’s oversight of the drug supply chain. It was disclosed that the GAO repeatedly found the FDA does not police or protect the drug supply chain adequately. The FDA was put on the GAO’s high-risk watch list of government agencies.