汤森路透：药业新闻大事件 — 美国大选后FDA将面临重大变革？

汤森路透走访多位相关人士后做出相关报道：

随着国会权利在两党间的交替以及21th Century Cures Initiative的巨大推动力，势必使FDA在2015年作出重大变革。

关于Cures改革的讨论草案，预计会在一月份推出，很可能会改变药物和设备开发流程，这会导致综合立法在今年晚些时候通过，Latham & Watkins’医疗保健和生命科学实践的合作伙伴和国际联合主席John Manthei说。

“这将是一个雄心勃勃的计划”Cures的首创说。“我认为无论是来自共和党还是民主党的能量都是存在的。”该倡议一直获得众议院能源和商业（E&C）委员会及其健康小组委员会的大力支持。

原文：

A shift in congressional power， coupled with the momentum being built by the 21st Century Cures Initiative， is set to deliver significant changes to the FDA in 2015.

A discussion draft of the Cures reforms， which is likely to change the drug and device development process， is expected to be rolled out in January， leading to the passage of comprehensive legislation later in the year， said John Manthei， partner and global co-chair of Latham & Watkins’ health care and life sciences practice.

“This will be an ambitious undertaking，” he said of the Cures initiative. “I think the energy from both the Republicans and Democrats is there.” The initiative has enjoyed strong bipartisan support in the House Energy and Commerce (E&C) Committee， as well as in its health Subcommittee.

As a result of that support， Manthei predicted 2015 will see the broadest scope of FDA reforms ever for a year in which Congress isn’t re-authorizing the five-year drug and devICE user fee package.

Along with those reforms， Manthei expects the Republican-controlled Congress to exercise more oversight of the FDA， seeking greater transparency， predictability and accountability in the agency’s dealings with industry and in its handling of resources.

Even before the Republicans gained control of the Senate and increased their hold on the House in Tuesday’s election， the House and Senate committees that deal largely with FDA issues were facing some leadership changes in the 114th Congress， which will be seated in January.

Tom Harkin (D-Iowa)， long-time chairman of the Senate Health， Education， Labor and Pensions (HELP) Committee， is retiring this year. With the Republicans at the helm， Manthei expects Sen. Lamar Alexander (R-Tenn.)， the ranking member， to be named the new chairman. Much of Harkins’ staff， with its institutional memory of all things FDA， also is expected to stay.

The committee’s only election night casualty was Sen. Kay Hagan (D-N.C.)， who narrowly lost to Republican Thom Tillis. Of course， when the new Congress takes office， some HELP members may be reassigned to different committees.

On the House side， Rep. fred Upton (R-Mich.)， who is co-sponsoring the Cures initiative along with Rep. Diana DeGette (D-Colo.)， will retain his E&C chairmanship， and Rep. Joe Pitts (R-Pa.) is likely to remain as chairman of the Health Subcommittee.

On the Democrat side， Reps. Frank Pallone (N.J.) and Anna Eshoo (Calif.) are battling for the E&C ranking member seat that’s being vacated by the retirement of Rep. Henry Waxman (D-Calif.). Pallone， the current ranking member of the Health Subcommittee， is in line for the leadership seat in terms of seniority， but House Minority Leader Nancy Pelosi (D-Calif.) is expected to campaign for Eshoo， Manthei said.

In addition to vacating his E&C spot， Waxman’s retirement will be felt in the Health Subcommittee， where he has been an active voice. Rep. John Dingell (D-Mich.) also is retiring. Adding to their loss will be the departure of their experienced staff， Manthei said.

Several other seats on the Health Subcommittee will be up for grabs in the new Congress. Rep. Bill Cassidy (R-La.)， a doctor who has been an insightful and vocal member of the subcommittee， gave up his House seat to challenge Sen. Mary Landrieu (D-La.). Republican members Mike Rogers (Mich.) and Phil Gingrey (Ga.) didn’t run for re-election， and Rep. John Barrow (D-Ga.) was defeated in his re-election bid.(生物谷Bioon.com)