Today, the House Subcommittee on Oversight and Investigations held hearings entitled FDA Foreign Drug Inspection Program: A System at Risk. These hearings should serve as a warning to the world that the dangers of drug safety are widespread, systemic, and uncontrollable by any government agency, especially the Food and Drug Administration (FDA). The result of a largely unregulated pharmaceutical industry can be devastating if steps are not taken now.
Since the food and toy recalls in 2007, the federal government has been under the microscope to explain how tainted products are making their way into the US retail supply chain.
The lack of oversight of pharmaceuticals is a little more insidious. When someone takes medication because they are sick, and they do not get well, there are many factors that could contribute to this, not the least of which is the fact that patients respond differently to treatment.
The fear is that there is no accountability for prescription pharmaceuticals from approval to dispensing, and although it doesn’t seem possible, accountability is even less for drugs manufactured in other countries. Countries such as China and India, who do not have much regulatory structure in place, also do not have the infrastructure to control the chain of custody of the raw materials prior to manufacture and the finished formulary after manufacture.
For example, a drug is manufactured in India and it meets all the specifications needed to ensure the quality of the pharmaceutical. The pharmaceutical is shipped, and the shipment sits in an unventilated warehouse for four days before being sent to the US. The heat from the unventilated warehouse causes the chemical compound in the drug to break down.
The parcel is shipped to the US, distributed to pharmacies and dispensed to you, and you have an adverse reaction. Is it because of your personal chemical makeup or because the drug is adulterated?
How would you know? Why would you question it? These are controlled substances, aren’t they?
In my series <i>How Good Are Your Drugs</i> (Part I, II, III, IV), I have explored these issues, and at the urging of groups such as the Government Accountability Project (GAP), Prevent Medical Error (PME) and Community Catalyst, the federal government is beginning to address this very important issue.
The general public assumes that the term “FDA Approved” means that the highest standards have been applied to the authenticity and safety of the approved pharmaceutical. It is further believed that prescription pharmaceuticals are tightly controlled from user approval until they are dispensed at the local pharmacy.
This is just not true. Pharmaceuticals are bought and sold in arbitrage on the world market. The proliferation of internet pharmacies, both regulated and illegitimate, has put the United States public increasingly at risk for adulterated and fraudulent drug dispenses.
The Pharmaceutical Supply Chain Lacks FDA Chain of Custody Oversight
And the FDA does not have the resources or the systems in place to stop it. The complacency of the FDA to control the process and the supply chain of generic drugs from overseas manufacturers in China and India has placed the entire U.S. population at risk.
There are an estimated 400 – 6,000 wholesalers who act as the middlemen, buying and selling medications as arbitrage. Stockpiling of drugs to reduce supply may occur and it can drive up prices. These medications may be released when prices escalate with little or no regard for safe storage or expiration dates to protect the consumer.
In some cases, fraudulent medications are repackaged and resold as manufacturer items. Some expire and are repackaged with new expiration dates. There have been reported instances where medications whose potency and effectiveness are affected by the elements have not been properly stored. When this adulteration occurs, the chemical components can break down render the drugs ineffective at best, and potentially harmful in a worst case scenario.