Increased Competition and Expansion in the Pharmaceutical Industry Creates Opportunity for Increased Corruption in Pharmaceutical Procement and Expands the Opportunity for Fraud in Pharmaceutical Drug Supply Chains that can create Dangerous Adulterated Drugs by International Adulterated Drug Whistleblower Lawyer and International Pharmaceutical Executive Whistleblower Reward Lawyer Jason S. Coomer
Included in this globalization of the pharmaceutical industry is a shift in many international pharmaceutical manufacturing supply chains where raw material supplies for pharmaceuticals, medical supplies, and medical equipment that were traditionally from the United States and Europe are now produced in from China and India as well as other emerging countries. This manufacturing shift create has created an environment where adulterated ingredients to pharmaceuticals, medical supplies, and medical devices may be used in the manufacturing of these products and can create dangerous and defective drugs, medical supplies, and medical devices being purchased by governments and given to patients.
In the fiercely competitive medical device, medical supply, and pharmaceutical markets, there are strong economic incentives to search for the cheapest ingredients and methods to produce products. Often these cheaper ingredients and manufacturing locations are in countries where standards and regulations are less stringent and corruption is more common. When large corporations set up subsidiaries and joint venture partners in these countries, good manufacturing practices can often suffer, fraudulent actors can cut corners to reduce costs, and cheaper sometimes toxic materials can be added to the products.
Example of this scenario include the Baxter Heparin Recall in 2008 where Baxter, a US pharmaceutical firm which manufactures approximately 50% of the US heparin products, voluntarily recalled its heparin due to nearly 350 reported adverse events, including 19 deaths. In investigating this case, the USFDA revealed that the recalled heparin products contained a contaminated API. The tainted API, imported from Changzhou SPL China, contained a heparin-like contaminant that was structurally similar to heparin and not recognized in the solution until the FDA developed special testing for it. In March 2008, the FDA announced that they had identified the contaminant to be an altered form of an oversulfated chondroitin sulfate which is not a natural byproduct of the heparin manufacturing process. In April 2008, the US government held hearings and determined the cause to be non-sterile equipment, lack of following proper procedures, and lack of expertise.
Further, supply chains that are bigger and more complex present more opportunities for fraud. As such, when a large corporation has a supply chain with several international subsidiaries and joint venture partners throughout the world, there are numerous opportunities along the supply chain for fraud to occur including supplier fraud, purchase order fraud, good manufacturing practices fraud, inventory fraud, documentation fraud, export fraud, import fraud, and other pharmaceutical fraud.
International Whistleblowers along the pharmaceutical supply chain and other health care professionals are being offered large potential rewards to blow the whistle on adulterated pharmaceutical ingredients, adulterated medicine, adulterated drugs, contaminated medical supplies, and defective medical devices. These whistleblower rewards can come from SEC Whistleblower Reward Lawsuits and traditional Qui Tam False Claims Act Whistleblower Reward Lawsuits. For more information on these potential whistleblower rewards, feel free to go to the following web pages: International Adulterated Drug Supply Chain Whistleblower Reward Lawsuits and Drug Safety Fraud Qui Tam Adulterated Drug Whistleblower Reward Lawsuits.