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製薬における政治:連邦政府、州政府および裁判所の産業における影響

The Politics of Pharma - Washington, States, and the Courts Impact on the Industry

発行 CBR Pharma Insights 商品コード 274484
出版日 ページ情報 英文
納期: 即日から翌営業日
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本日の銀行送金レート: 1USD=114.71円で換算しております。
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製薬における政治:連邦政府、州政府および裁判所の産業における影響 The Politics of Pharma - Washington, States, and the Courts Impact on the Industry
出版日: 2013年04月01日 ページ情報: 英文
概要

当レポートでは、米国において政治が製薬業界に及ぼす短期的・長期的な影響について調査し、最高裁判所における現在の製薬関連の問題、11月の選挙が現在・将来の製薬産業に及ぼす影響、製薬企業はどこに政治的なフォーカスを置くべきか、州の政治が製薬企業にとってますます重要となりつつある理由、および製薬産業の展望などについてまとめ、概略以下の構成でお届けします。

エグゼクティブサマリー

第1章 11月の選挙結果

  • 選挙における製薬企業の投資
  • 選挙結果
  • 医療機器税
  • 鎮痛剤に対する議会の注目
  • FDA

第2章 医療制度改革

  • 実行
  • サンシャイン法
  • データベースの有意義な利用

第3章 州の政治

  • 州の医療エクスチェンジ
  • バイオシミラー代替品

第4章 裁判所

  • Pay-for-delay (逆支払を伴う和解)
  • ジェネリック医薬品の信頼性
  • 改革
  • オフラベルの利用

第5章 政治的展望

  • 予算逼迫の影響
  • メディケア(Medicare)
  • インドの貿易門弾
  • CBRの見解

付録

目次
Product Code: CBRSV042

Politics have a greater direct effect on the pharmaceutical industry than almost any other in the US, and correspondingly, pharma makes considerable investments in election campaigns. The November elections kept the face of Washington the same, with the re-election of President Obama, Democratic control of the Senate and Republican control of the House. However, the outcome of the elections will still impact the industry in a variety of ways.

The Medical Device Excise Tax, a component of the 2010 health care reform legislation, survived a pre-election Congressional effort at repeal, but a coalition of House Republicans and Democrats from key states are looking to try again. Post-election, another bi-partisan congressional group is pushing for the FDA to impose stricter regulations on certain painkillers. Meanwhile, the Administration's prioritization of generics at the FDA remains controversial.

The budget impasse and resulting sequestration are election fall-outs that may impact the pharmaceutical industry in a number of ways: decreased vaccine sales, reduced research funding and potential cuts at the FDA that could dramatically raise time to market. Medicare reform also looms out as an issue un-resolved in November, with the possibility of playing a role in the mid-term elections

The report, “The Politics of Pharma” was written to provide companies with an update and future outlook of how the political atmosphere within the United States will impact the pharmaceutical industry in both the near and long term. This report should be used by both large and small organizations alike, as well as branded and generics manufacturers.

Key Reasons to Purchase

  • Understand the current pharmaceutical related issues before the Supreme Court
  • Assess the impact of the November elections on the political issues that affect pharma now and in the future
  • Evaluate where pharmaceutical companies should turn their political focus
  • Analyze why state politics are increasingly important to pharmaceutical companies and the impact they could have on future revenues
  • Examine the potential impact from the current budget impasse
  • Benefit from accessing CBR's view on the outlook for the pharmaceutical industry as a result of the political climate in the United States

Table of Contents

Executive Summary

Chapter 1: November Election Results

  • Pharma's investment in the elections
  • Election results
  • Medical device tax
  • Congressional spotlight on painkillers
  • The FDA

Chapter 2: Health Care Reform

  • Implementation
  • The Sunshine Act
  • Meaningful use debate

Chapter 3: State Politics

  • State Health Care Exchanges
  • Biosimilar substitution

Chapter 4: The Courts

  • Pay-for-delay
  • Generics liability
  • Reform
  • Off-label use

Chapter 5: The Political Outlook

  • Impact of the budget impasse
  • Medicare
  • Indian trade issues
  • The CBR View

Appendix

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