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.
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