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美国政府陷入史上最长时间停摆!FDA新药审评工作暂停,只能再维持1个月

医药魔方 医药魔方 来源:医药魔方
2019-01-13
停摆
原文

1月13日,美国政府部分停摆进入第22天,超过1996年克林顿执政期间21天的政府最长停摆时间,创下新记录。而且从目前的形势看,特朗普总统似乎无意向民主党妥协,在上周更是发推表示政府可能停摆数月甚至一年,直到民主党同意拨款支持他的美墨边境墙修建计划。


FDA自去年12月22日停摆以来,只维持关键职能的运行,也是步履维艰。



正常情况下,FDA各分支机构维持职能运行的开支主要依赖于政府拨款和各种使用者付费(user fees)。但是自从特朗普总统与民主党产生对峙导致美国政府部分停摆以后,FDA的2019财年付费法案和预算也一直未获得批准。停摆期间,FDA无法从政府获得拨款,也无法从制药企业那里收取任何的使用者费用。


1月9日,FDA局长Scott Gottlieb在通过网络在JP摩根大会上更新了FDA的最新财务状况。Gottlieb本人无法亲自参加会议,因为在政府停摆期间,政府官员的公务出行是受限制的。


信息显示,FDA各个分支机构通过各种付费法案收缴的资金结余仅能让其药品分支机构的关键职能继续运行1个月,让医疗器械机构继续运行2~3个月,让仿制药机构继续运行数月。


Gottlieb: FDA将维持最关键职能的运行

 

Gottlieb在Twitter上发布信息指出:“FDA正在采取措施减少财政损耗以及重新分配资源。其中一项措施是把原本支持某些药物上市审评工作的费用配置到上市后药物的安全性监测上面(编辑注:意味着新药审批工作暂时停滞)。我们期望FDA保护消费者安全工作中最重要的部分能够继续维持下去。”


政府停摆无疑会对那些没有薪水也要继续工作的联邦雇员的生活产生影响。药品审评机构的工作人员尚能从2018财年的使用者付费资金池中继续领取工资,但是对于其他一些需要联邦政府拨款资助的工种,这些雇员们将无法再领取薪水。政府部门一些事务的承包商在政府停摆后通常会认为双方的雇佣关系一概中断或终止。

 

美国政府上一次陷入长时间停摆则是2013年共和党抗议奥巴马医改所推出的《平价医疗方案》(ACA法案)引起的,持续了16天,那次停摆也让美国80万联邦雇员集体休假。


Gottlieb表示,政府停摆对FDA一些必要的公务出行也造成很大影响,比如对食品和药品生产现场的检查。FDA目前的解决办法是将这类公务出行的支出集中到一张信用卡上,避免FDA雇员们自掏腰包。但是由于政府停摆时间的不确定性,类似食品安全例行检查等工作已经停止。

 

Gottlieb指出:FDA的工作没有一项是不重要的,但是在目前资金状况下,我们也只能尽自己最大职责保持那些会直接影响到消费者安全的工作继续运行下去。”


机器翻译
On january 13th, the u.s. government partially closed for the 22nd day, setting a new record by exceeding the 21-day government's maximum lockout period during clinton's administration in 1996.And, judging from the current situation, President Trump seems to have no intention of giving in to the Democrats, even more so last week, saying that the government could stop for months or even a year until the Democrats agreed to fund his US-Mexico border wall construction plan.

Since the FDA shutdown on December 22 last year, it has only maintained the operation of key functions and is also struggling.

Under normal circumstances, the expenditures of FDA branches to maintain their functions mainly depend on government grants and various user payments.But since President Trump's confrontation with the Democrats led to a partial shutdown of the US government, the FDA's FY 2019 payment bill and budget have not been approved.During the shutdown, the FDA was unable to obtain funding from the government or collect any user fees from pharmaceutical companies.

On January 9, FDA Director Scott Gottlieb updated the FDA's latest financial status at the JP Morgan conference via the web.Gottlieb himself was unable to attend the meeting in person because official travel was restricted during the shutdown.

Information shows that the balance of funds collected by various FDA branches through various payment bills can only allow the key functions of their drug branches to continue operating for one month, allowing medical device institutions to continue operating for two to three months, and allowing generic drug institutions to continue operating for several months.

GottliebOne measure would be to allocate the costs that would otherwise support some drug marketing reviews to post-marketing drug safety monitoring.We expect the most important part of the FDA's efforts to protect consumer safety to continue."

The shutdown of the government will undoubtedly have an impact on the lives of federal employees who do not have a salary and continue to work.Drug review agency staff will still be able to collect salaries from the user pool in FY2018, but for some other jobs that require federal funding, they will no longer be able to collect salaries.Contractors in some government affairs usually assume that the employment relationship between the two parties will be interrupted or terminated after the government has stopped.

The last time the U.S. government was caught in a long pause was caused by the 2013 Republican protest against Obama's "Affordable Care" (ACA) bill, which lasted 16 days. The pause also left 800,000 U.S. federal employees on collective leave.

Gottlieb said that the shutdown of the government has also had a great impact on some of the FDA's necessary official trips, such as inspections of food and drug production sites.The FDA's current solution is to focus spending on such official trips on a credit card to avoid FDA employees paying for themselves.However, due to the uncertainty of the shutdown time of the government, similar routine inspections of food safety have been stopped.

Gottlieb pointed out: None of the FDA's work is unimportant, but in the current funding situation, we can only do our utmost to keep those jobs that will directly affect consumer safety from continuing.

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