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Modify the FDA Drug Approval Process

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The Food and Drug Administration (FDA) is in charge of approving pharmaceuticals in the United States. ?It takes on average 12 years and over US$350 million to get a new drug from the laboratory onto the pharmacy shelf (source http://www.drugs.com/fda-approval-process.html). As such, the current approval process often delays the release of badly needed drugs and certainly leads to increased pharmaceutical costs which are passed onto the consumers. Further, given the high cost of and time involved in bringing drugs and treatments to market in the United States, US citizens are turning to foreign countries for treatments and to buy their medications. This hurts US citizens in two ways. First, it denies them of badly needed medications. Next, it unnecessarily adds to the financial burden of being sick as it increases drug costs in the US. Equally, important not enough monies are being dedicated to researching effective treatments for pandemic types of diseases.

Proposed

We the petitioners ask the United States government to examine and modify the FDA drug approval process. The current process involves a Phase I and II which tests safety and effectiveness. We ask that drugs be released to patients immediately after successfully passing a Phase II trial. Further, we ask that the process be designed such that all drugs successfully passing a Phase II are approved for distribution and that this process be designed such that it takes no longer than 4 calendar years (1,460 days) for approval of new drugs/treatments.

Additionally, we the petitioners also ask the US government to enter reciprocity agreements with other developed countries/jurisdictions, including but not limited to Canada, Europe, Australia and Japan. This will increase our access to medicines and treatments that have already been tested, it will open up their markets for our medicines and treatments and it will help to minimize the black market that has developed.

Further, we the petitioners also ask that all medicines/treatments be candidates for Fast Track status. The current protocol appears to limit Fast Track status to drugs/treatments primarily affecting terminally ill patients and as such fails to consider diseases such as HSV1 and 2 which are highly prevalent in society (up to 50 million people in the US have HSV2, and as many as 100 million have HSV1).

Lastly, we the petitioners also ask that not only quantity of life be considered when awarding taxpayer research dollars, but that also quality of life be considered. As such, we ask for a significant funding increase for cure/treatment research for both HSV1 and 2.

Sincerely,


A Concerned Citizen

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