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Modify the FDA Drug Approval Process

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Current<br />
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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.<br />
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Proposed<br />
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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.<br />
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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.<br />
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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). <br />
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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.<br />
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Sincerely,<br />
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<br />
A Concerned Citizen

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Public Comments (331)
Feb 11th, 2017
Someone from Birmingham, AL writes:
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It's ridiculous to make people wait so long for a drug that could help millions of sufferers. Not to mention the fact of not spreading this virus. Why not release this drug!?
Feb 9th, 2017
Dina S. from Flushing, NY signed.
Jan 30th, 2017
Toni S. from Shelby, MI signed.
Jan 14th, 2017
Someone from Beverly Hills, CA signed.
Dec 5th, 2016
Someone from Aurora, CO writes:
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Freedom of choice for me please. Pritelivir is the answer for me.
Dec 5th, 2016
Someone from Aurora, CO writes:
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Freedom of choice for me please. Pritelivir
Nov 28th, 2016
Someone from Easton, PA signed.
Nov 14th, 2016
Someone from San Diego, CA signed.
Oct 23rd, 2016
amanda n. from New York, NY writes:
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How can I explain this to the world that there is a man who can cure HERPES, I was diagnosed for the past 2years I have being into HERPES drug since then,so I decide to look for help in the internet then I found this man post write about this great man calld Dr Ojoku Onoss, telling people about him that this man have a cured to HERPES I don?t believe that because all I have in mind is HERPES had no cure, thank god for my life today am HERPES negative through the power of Ojoku Onoss, I contacted this man for help because who write about him drop an email of the man I pick the email and emailed him for the cure this man told me what to do about the cure well am from Australia this man cast a curing spell on me and he told me that he will call me after the cure is done truly he did I was cured , what a wonderful man is this , if you need his cured just email him now on ojokuonosshelphome@homail.com, or call him on +23478119886007 OR whatAspp him on +2348056377915 thank you DR i will never stop shearing you testimony DOCTOR OJOKU ONOSS CAN AS WELL CURE THE FOLLOWING DISEASE:- 1. HIV/AIDS 2. COPD 3. CANCER 4. ALS 4. Diseases of the heart 5. Malignant tumors 6. Cerebrovascular diseases 6. Diabetes mellitus 7. Influenza and pneumonia 8. Alzheimer's disease 9. Nephritis, nephrotic syndrome, and nephrosis 10.Septicemia (blood poisoning) 11 Chronic liver disease and cirrhosis 1.1 12.Primary hypertension and hypertensive renal disease 13.Parkinson's disease (tied) 14.Homicide (tied) 15.If you need LOVESPELL. E.T.C
Oct 21st, 2016
Brittany D. from Butler, GA writes:
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I was diagnosed of hepatitis in 2012 and I have tried all possible means to get cure but all to no avail, until i saw a post in a health forum about a herbal doctor from South Africa who prepare herbal medicine to cure all kind of diseases including hepatitis b virus, at first i doubted if it was real but decided to give it a try, when i contact this herbal doctor via his email, he prepared a herbal medicine and sent it to me via courier service, when i received this herbal medicine, he gave me step by instructions on how to apply it, when i applied it as instructed, i was cured of this deadly virus within 18-20 days of usage, I am now free from the virus, i was tasted negative. Contact this great herbal doctor via his email drlusandaherbal(at)gmail(dot)com or website on www(dot)drlusandaherbals(dot)weebly(dot)com Goodluck
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