2015年2月8日讯/生物谷BIOON/-- FDA最高行政长官Margaret Hamburg 2月5日向所有FDA职员写了一封公开信：她将于3月底结束在FDA的六年任期。这意味者Hamburg时代即将画上句号，谁会接替她成为下一任？
Hamburg今年已经59岁，是近几十年来在FDA任职时间最长的官员之一。在任职期间，Hamburg备受瞩目，功绩显赫的同时也时常站在风口浪尖，承受社会各界的批评和怨言。在她就职期间，曾强调以科学研究为各项工作的基础，加快医疗产品的审批，推进食品药品监督管理的全球化，建立更科学的患者管理制度。癌症研究之友主席Ellen Sigal赞扬Hamburg正是建立了以科研为本的制度从此“改变了FDA的风向”。在FDA刚刚公布的2014年成绩汇总中，我们可以看到：越来越多的药品被审批，阿片类制剂滥用有所控制，新抗生素的发现，埃博拉疫苗的研制，其他感染性疾病疫情的控制。此外，Hamburg还专注于医疗产品的安全性（比如无菌药品的规范化生产和使用），烟草产品的减少，食品安全问题。在辞职信中，Hamburg对FDA的工作做了总结，感谢员工的“专业、奉献和正直”。
Hamburg的辞职激起了千层浪花：国会、工商业、医疗机构、研究所等等都议论纷纷。有人推断杜克大学的心脏病专家Robert Califf有可能接替Hamburg担任FDA署长，目前他是专管医疗产品和烟草制品的副署长，曾经担任FDA咨询委员，作为重大医药研究的领头人，鼓励公私合作研究，制定新颖的举措使临床研究走向现代化，推进新药研发。当然，他也可能遭遇自由民主党的反对，因为这个党派向来反对工业化。
有专家分析，如果Califf想担任此职，在未来的听证会上，他应该强调他在北卡罗来纳州医药界的卓越贡献，他组织成立了转化医学委员会，该委员会将成千上万的科学家纳入麾下。这么大的成就足以赚取参议院分管健康领域的人士的支持。
Hamburg离职后，在这段过渡期，FDA首席科学家Stephen Ostroff将会担任代理署长。
未来的挑战
FDA的明天依然任务艰巨。更多的人呼吁医药研究有“重大突破”，医疗产品的成本效益应该准确评估，进口食品、药品安全性必须得到核查，实验室开发诊断试剂何去何从，医学诊断新技术的批准和监督，药品评价与研究中心对药物合成、处方药去向跟踪的立法，白宫和参议院对FDA的改革建议，紧张的财政支持，与企业的“免费产品”谈判等等。这些都是亟待解决的问题，无论是代理署长Stephen Ostroff还是以后上任的署长，压力着实不小。
英文原文：
After Hamburg: What Next for FDA?
Feb 06, 2015
By Jill Wechsler
It was no surprise that Commissioner Margaret (Peggy) Hamburg decided to call it a day after nearly six years at the helm of the US Food and Drug Administration (FDA). She has accomplished a great deal during her relatively long tenure leading this high-profile agency, but also has had to withstand constant criticism. The prospect of multiple reform proposals from a Republican-led Congress, limited funding increases from the White House, and the task of launching another round of user-fee negotiations with industry – and associated legislation -- were daunting prospects.
Hamburg’s announcement that she would leave FDA at the end of March generated a wave of kudos from Congressional leaders, industry organizations, medical groups and the research community. She is praised for emphasizing science-based regulation, for supporting efforts to streamline medical product approvals, for recognizing the challenges from a more globalized food and drug world, and for bringing patients more into the regulatory process. Friends of Cancer Research chair Ellen Sigal noted that Hamburg “changed the direction of the FDA” by encouraging “science-based collaboration.” In a recent summary of agency accomplishments for 2014 posted on the FDA website, Hamburg highlighted the surge in new drug approvals and efforts to curb opioid abuse, to promote new antibiotics and to facilitate development of vaccines against Ebola and other infectious diseases. She also noted attention to medical product safety, to halting compounding of unsterile drugs, to implementing new controls over tobacco products and to promoting food safety and nutrition. A lengthy farewell message to FDA staff reiterated these gains and praised their “expertise, dedication and integrity.”
Changes ahead
Hamburg is departing with two years left in the Obama administration, enough time to nominate and seek Senate approval of another FDA commissioner, if the administration chooses to do so. Or FDA could be left with an acting commissioner for the duration, with FDA chief scientist Stephen Ostroff filling that role after Hamburg leaves in late March.
There has been rampant speculation that Duke University cardiologist Robert Califf would be named to the top spot, following his recent appointment as FDA deputy commissioner for medical products and tobacco. He has served on FDA advisory committees, led important Institute of Medicine studies, supported multiple public-private research partnerships, and championed strategies to modernize clinical research. He also has worked with industry in designing and conducting clinical studies and developing new medicines, experience that might raise some objections from liberal Democrats about a pro-industry bias.
If Califf does face confirmation hearings, he should be able to tap his prominence in North Carolina medical circles, where he has led the Duke Translational Medicine Institute, a large operation that employs hundreds of researchers and scientists. That should generate support from Sen. Richard Burr (R-NC), a prominent member of the Senate and of the Health, Education, Labor and Pension (HELP) Committee, which handles FDA confirmation. Laksman Ramamurthy, director for FDA regulatory policy at Avalere Health, says he’s optimistic about Senate confirmation of a new FDA commissioner, as Senate Republicans will want to prove that they can make government work running up to the 2016 presidential elections.
Even if the White House decides to avoid a battle over FDA’s functions and future, Califf will play a prominent role in leading FDA over the next two years as it continues to face new challenges. While there is enthusiasm for accelerating the approval of more “breakthrough” drugs, that program may draw more scrutiny as some initial breakthroughs prove to be less effective than expected. There is pressure on FDA to do more to assess the cost-effectiveness of new medical products and to ensure the safety of the growing volume of medicines and foods imported from abroad. One FDA initiative that may fall by the wayside is the agency’s recent move to regulate laboratory-developed tests (LDTs), which is strongly opposed by independent test laboratories as well as the medical community. And medical diagnostic firms remain nervous about how FDA proposes to monitor new technologies.
The Center for Drug Evaluation and Research is working overtime to implement recent legislation that sets new rules pharmacy compounding and for tracking the distribution of prescription drugs. Republicans in the House and the Senate have offered lengthy proposals for reforming FDA operations and policies, most notably the “21st Century Cures” package from the House Energy & Commerce Committee. The new (acting) commissioner will have to deal with these and many more issues.