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Government Regulations for New Drugs

In: Science

Submitted By nabeel58
Words 865
Pages 4
Government Regulations
Laws in the United States for mass production and commercial use of a drug are amongst the strictest and most costly to develop in the world. US demands for prescription drugs in 2009 was $300 billion, which was a massive 40% of the world population. In terms of strictness, drugs have to go through many tests by numerous regulatory agencies before getting approved for mass production. The self-diagnostic kit that tests for Influenza, Pink eye and Respiratory Syncytial Virus (RSV) has to be approved by the Food and Drug Administration (FDA), the Consumer Product Safety Commission (CPSC) and the Environmental Protection Agency (EPA).
The obvious government regulation needed is the one from the Food and Drug Administration (FDA). Before any drug, or in our case a drug diagnostic kit, hits the market, it has to go through many trials and tests before it is approved. “As with all products regulated by FDA, rigorous reviews of laboratory and clinical data are needed to ensure the safety, efficacy, purity and potency of these products.”
Due to the fact that the self-diagnostic test is going to be a commercially used product for humans, it has to be approved by the Clinical Laboratory Improvement Amendments (CLIA), which are a part of the FDA. CLIA are federal regulatory standards in the United States created in 1988 for any laboratory tests that are performed on humans. One major competitor, QuickVue, which is a diagnostic for influenza A and B has also been CLIA approved, illustrating that our diagnostic kit must be as well.
One major issue with having a self-diagnostic test at home is that there is no supervision of a trained medical professional. Thus, there is potential for things to go wrong; either people might perform the tests wrong or they might even hurt themselves or their children. Due to this issue, testing and approval from the Consumer Product Safety Commission (CPSC) is needed to show that the self-diagnostic kit is suitable for unsupervised use. After rigorous approval from both CLIA and the CPSC, it can be assured the drug is safe for human use.
The Environmental Protection Agency would also be concerned with the sale of our drug because of the waste the self-diagnostic kit has potential for. Firstly, the manufacturing of the diagnostic kit will most definitely leave waste residue. Is the waste going to be recycled or thrown away into the environment? Secondly, the actual self-diagnostic kit in the hands of the consumer will be disposed after use. How bad are the materials used for the diagnostic kit for the environment? Are they recyclable? This are issues needed to be addressed and tested by the EPA to see if the diagnostic kit is fit for commercial sale.
To go through the rigorous procedures, we base our timeline on one of our competitors, QuickVue. It took QuickVue approximately 2 to 3 years to go through the rigorous procedures and testing by the numerous regulatory agencies stated above, thus we assume it would take us around the same time to get approved. Since our drug diagnostic test is not a new drug, we would not have to spend as much time and money for research and development as we would if we were selling a new drug. Within this timeline, it would take approximately 1 year for research and development. After this, another year or two would be needed for the product to be ready for commercial sale. This is entirely dependent on if the testing goes smoothly, and if there are no major obstacles barring the launch of the product. It is important to note that since our diagnostic kits are most definitely not the same (QuickVue tests for only one disease whereas we test for three), the timeline could very well be very different.
"The pharmaceutical industry: an overview of CPI, PPI, and IPP methodology ." Pharmaceutical industry. N.p., n.d. Web. 25 Oct. 2012. <
"U S Food and Drug Administration Home Page." U S Food and Drug Administration Home Page. N.p., n.d. Web. 25 Oct. 2012.
"Influenza Test Kits." Wholesale Direct Prices on Diagnostic Testing Products. Pregnancy, Fertility & Ovulation, Drug & Alcohol Screening, and General Health Test Kits. Easy, Affordable, "At Home" Diagnostics.. N.p., n.d. Web. 25 Oct. 2012. <
"Clinical Laboratory Improvements Amendment (CLIA)." FDA. N.p., n.d. Web. 24 Oct. 2012. <
"CPSC Home Page | ." CPSC Home Page | . N.p., n.d. Web. 25 Oct. 2012. <>.
"Development & Approval Process (Drugs)." U S Food and Drug Administration Home Page. N.p., n.d. Web. 25 Oct. 2012. <
"Guidance Compliance Regulatory Information." FDA. N.p., n.d. Web. 24 Oct. 2012. <
"US Environmental Protection Agency."US Environmental Protection Agency. N.p., n.d. Web. 25 Oct. 2012. <>.

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