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白宫要求法院驳回药品进口诉讼

2021-05-30 11:44   美国新闻网   - 

Ron DeSantis

美联社

文件-在这个星期六,2021年5月8日,文件照片,佛罗里达州州长罗恩·德桑蒂斯,观看四人组

佛罗里达州塔拉哈西——拜登政府敦促联邦法院驳回一项诉讼,该诉讼可能阻碍佛罗里达州和其他从加拿大进口处方药的州。

白宫在周五提交的一份法律简报中辩称,去年代表美国制药公司提起的诉讼为时过早,因为联邦政府尚未批准任何进口计划。

政府提交法律文件的同一天,佛罗里达州共和党州长呼吁拜登政府批准其药品进口申请。佛罗里达州共和党州长正在考虑2024年竞选白宫。

佛罗里达和新墨西哥州是迄今为止唯一两个正式要求美国政府允许联邦政府批准的药物从加拿大进口的州,认为这样做会为美国人节省数百万美元。其他州也准备效仿,尽管代表美国药品生产商的贸易组织美国药物研究与制造商协会提起了一项诉讼,引起了人们对安全性和成本的担忧。

乔·拜登总统的政府在法律文件中辩称,制药公司“先发制人地发起了这场大规模攻击”,针对的是一个尚未实施的项目。

“尽管已经向FDA提交了两项提案,但该机构没有做出决定的时间表,”政府的动议指出。

在周五的新闻发布会上,佛罗里达州州长罗恩·德桑蒂斯(Ron DeSantis)表示,在该项目的第一年,佛罗里达人可以节省高达1.5亿美元的药物费用。

德桑蒂斯在2019年签署了一项法案,允许从邻国进口处方药,但该计划有待联邦政府批准。

11月,时任总统唐纳德·特朗普(Donald Trump)领导下的美国卫生与公众服务部(U . S . Desantis)发布了一项裁决,德桑蒂斯表示,该裁决主要基于佛罗里达州的计划,进一步为各州寻求进口处方药打开了大门。同月,该贸易集团提起诉讼。

州长办公室周五发表声明称,本届政府的法律文件“将拜登政府记录在案,支持FDA的规定”。

这位佛罗里达州州长越来越多地以好斗的语气反对拜登政府,因为他将自己定位为该党对现任白宫的主要批评者之一。

“令人失望的是,美国食品和药物管理局似乎没有时间表来审查今天的文件中提到的任何州进口提案,”州长的声明说。“佛罗里达人为了降低药价已经等了很久了,没有什么好的理由让他们等下去。”

一些消费者长期以来穿越墨西哥和加拿大购买价格远低于美国的药物。但是进口毒品是违反联邦法律的。

美国制药研究和制造商协会提起的诉讼指控联邦政府未能证明进口药物的安全性和任何实际的成本节约。

德桑蒂斯和其他人否认了这些担忧,称加拿大和美国一样,有严格的制药指南,“我们显然会有确保质量的流程。”

德桑蒂斯说,如果联邦政府批准其启动药品进口计划的请求,他的州准备迅速采取行动实施该计划。

White House asks court to dismiss lawsuit over drug imports

TALLAHASSEE, Fla. -- The Biden administration is urging a federal court to dismiss a lawsuit that could stand in the way ofFloridaand other states importing prescription drugs from Canada.

In a legal brief filed Friday, the White House argues that the lawsuit filed last year on behalf of U.S. pharmaceutical companies was premature because the federal government has yet to approve any importation programs.

The administration’s legal filing came on the same day Florida's Republican governor, who is considering a run for the White House in 2024, called on the Biden administration to approve its drug importation application.

Florida and New Mexico are the only two states thus far to formally ask the U.S. government to allow federally approved drugs to be imported from Canada, arguing that doing so would save Americans millions of dollars. Other states are poised to follow, despite a lawsuit raising concerns over safety and costs that was filed by the Pharmaceutical Research & Manufacturers of America, the trade group that represents U.S. drug producers.

In its legal filing, President Joe Biden's administration argues that drug companies “pre-emptively launched this wholesale attack” on a program that has yet to be implemented.

“Although two proposals have been submitted to FDA, no timeline exists for the agency to make a decision,” the government’s motion states.

During a Friday news conference, Florida Gov. Ron DeSantis said Floridians could save as much as $150 million in drug costs in the program's first year.

DeSantis signed a bill in 2019 allowing prescription drugs to be imported from the neighboring country, but the plan awaits federal approval.

In November, the U.S. Department of Health and Human Services under then-President Donald Trump issued a ruling, which DeSantis said was based largely on Florida's plan, further opening the door for states to pursue importing prescription drugs. That same month, the trade group filed its lawsuit.

The governor’s office on Friday issued a statement asserting that the current government's legal filing “puts the Biden Administration on the record in support of the FDA rule.”

The Florida governor has increasingly taken a combative tone against the Biden administration as he positions himself as one of his party's leading critics of the current White House.

“It is disappointing that the FDA appears to have no timeline to review any state importation proposals as referenced in today’s filing,” the governor's statement said. “Floridians have been waiting long enough for lower drug prices, and there is no good reason to keep them waiting."

Some consumers have long crossed into Mexico and Canada to buy medicine that sells for far less than in the United States. But it's against federal law to import drugs.

The lawsuit filed by the Pharmaceutical Research & Manufacturers of America accuses the federal government of failing to demonstrate the safety of importing medicine and any actual cost savings.

DeSantis and others have dismissed those concerns, saying that Canada, like the United States, has stringent pharmaceutical guidelines, and "we obviously would have our process to ensure quality.”

DeSantis said his state is ready to act swiftly to put its program into place should the federal government approve its request to launch a drug importation program.

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