Essay 4

Submitted By jstremfel
Words: 3894
Pages: 16

Jordan Stremfel
Dr. Joshua
English 1A, Essay 4
December 9th, 2013
H.R. 1910 The Foreign Manufacturers Legal Accountability Act of 2013:
Unregulated Foreign Pharmaceutical Manufacturing Put the Public’s Health at Risk and the FDA Needs Help! On January 7th, 2011 Cheryl Eckard, the quality control manager for the huge pharmaceutical company GlaxoSmithKline, blew the whistle on them for using foreign factories that had broken equipment, were not safe, and most importantly were not clean or sterile. They continued production and distribution from this factory even after she had brought these issues to their attention. In an 2011 interview with CBS News, after she had blown the whistle on Glaxo, Eckard says: “water used to make tablets were tainted with bacteria; failures on production lines made some drugs too strong, some not strong enough; and the employees were contaminating products”(Eckard). She basically tells us that the factory and its employees were not up to code. Also in this interview, Eckard gives us an example of what happens when factories like this are in operation: A grandmother went to pick up her grandchild’s antidepressant medication at the pharmacy. She was very concerned because her grandson had been very ill for the past month. When she arrived, she opened the prescription in front of the pharmacist. When she saw that the pills were yellow she became very upset because his medication had always been yellow, yet the previous month they had been pink. He had become ill because the pharmaceutical company’s foreign factory had mixed up the medications. They had put the wrong strength medication in the wrong bottle. He had been taking more than double of his prescribed dose(Eckard). This event, along with countless others, occurred because pharmaceutical companies are using foreign or overseas factories to manufacture their drugs. Unfortunately, Glaxo is not the only pharmaceutical company which takes part in overseas production. All of the pharmaceutical companies do. In 2011 Eckard was awarded the largest whistleblower settlement in U.S. history receiving $96 million. Glaxo plead guilty and was ordered to pay $750 million to settle the criminal conviction. Here in the United States, as Americans we pay the highest amount recorded for our prescription drugs. When we pick up our prescriptions we trust that we are receiving the right medications as prescribed by a doctor and that they will be of the highest quality. This idea or trust stems from the Food and Drug Administration or FDA. The FDA’s job is to ensure that all of the drugs that are manufactured or brought in to the United States are safe, approved, and of the highest quality. This is not happening. People are becoming ill and dying because pharmaceutical companies are trying to cut production costs by manufacturing overseas. Pharmaceutical companies are using foreign factories to manufacture drugs outside of the U.S. because it is much cheaper but primarily because the FDA does not do its part when it comes to overseas operations. The FDA is not doing its job conducting regular inspections and enforcing regulations on foreign and overseas pharmaceutical factories. This is the reason pharmaceutical companies are getting away with using dirty, broken factories that produce medications that can be unsafe. This is an important U.S. systemic problem because the health of millions of Americans is at risk. The problem occurs because the FDA subjects foreign factories to fewer inspections, the FDA’s cost of inspection of foreign factories is much higher than domestic ones, and the FDA gives foreign factories prior notice of audits and also spends less time inspecting them. First, the FDA visits all domestic pharmaceutical factories at least once every two years, but does not have the same requirements for inspecting factories overseas. In addition to the lack of inspections, it costs the FDA more than twice as much to inspect foreign factories then the