20111003 Petition 最新情報！

いよいよ、Petition to US Congressが開始されたようです！

具体的なサイトのURLは…、

Reform the FDA Drug Approval Process and Increase HSV 1/2 Research Funding
https://wwws.whitehouse.gov/petitions/%21/petition/reform-fda-drug-approval-process-and-increase-hsv-12-research-funding/CZjsHmWs

となります！

概要は、この前お伝えしたように…、

1. 現行の三審制みたいなシステムではなく、Phase Iで安全性をテストし、Phase IIで効果を確認するような二審制にして欲しい。
2. ヨーロッパ、オーストラリア、カナダ、メキシコと医薬品承認の協定を結び、協定国で認められた医薬品もアメリカ国内で手に入るようにして欲しい。
3. Phase 1の結果が良ければ、開発企業がすぐにでもFast Track申請できるようにして欲しい。

という内容になっているようです！

2011年11月1日までに、5000人分の署名を集めないと無効となるようですので、頑張ってほしいですね…！

Reform the FDA Drug Approval Process and Increase HSV 1/2 Research Funding
https://wwws.whitehouse.gov/petitions/%21/petition/reform-fda-drug-approval-process-and-increase-hsv-12-research-funding/CZjsHmWs

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. Too, 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.

Also, we the petitioners also ask the US government to enter drug reciprocity agreements with other developed countries/jurisdictions, including but not limited to Canada, Europe, Australia & Japan.

We also ask for increased HSV1/2 funding.

Created: Oct 02, 2011

Issues: Health Care, Job Creation, Women's Issues