美国国家公共电台 NPR--The legal battle over mifepristone raises concerns in the the pharmaceutical industry

The legal battle over mifepristone raises concerns in the the pharmaceutical¹ industry

Transcript²

NPR's Michel Martin speaks with Harvard Medical School's Ameet Sarpatwari about the legal battle over mifepristone and how it might affect the drug market in the U.S. and beyond.

MICHEL MARTIN, HOST:

As we've been following the legal battle over the abortion³ pill mifepristone, we've heard from activists⁴ and political leaders with different perspectives on abortion per se. But now we're starting to hear from people in the pharmaceutical industry. Hundreds of executives and investors⁵ recently issued an open letter decrying⁶ the Texas federal judge's order removing FDA approval from the drug. To hear more about these concerns, we called Ameet Sarpatwari, the assistant director of the program on regulation, therapeutics and law at Harvard Medical School. Good morning.

AMEET SARPATWARI: Good morning.

MARTIN: So what are the concerns you're hearing from the industry about this effort to remove the FDA's approval of mifepristone? And do you share them?

SARPATWARI: So I think that the industry is very concerned about the implications of this ruling because it effectively inserts the judiciary into the drug approval process. And this is a drug that's been on the market and has been safely and effectively used for over 23 years. Industry members are wondering, well, if a judge can do that, what else can't a judge, perhaps with an ax to grind, do?

And so you have executives at over more than 500 pharmaceutical companies calling out the judge for having no scientific training, fundamentally undermining the bipartisan authority granted by Congress to the FDA. You've got another trade organization, BIO, calling out the ruling, saying that the court has badly misapplied governing drug approval laws. And you also have the trade organization PhRMA referring and reinforcing the importance of the FDA as the gold standard for determining whether a drug is safe and effective. And I do share all these concerns. The question is, really, what would be off the table from relitigating?

MARTIN: Can I just jump in here and just ask - you know, one can make an argument that medical care in the United States is already a legal and political issue if you consider which procedures are covered, how care is paid for, what kinds of patient concerns are prioritized. There's always been lobbying and public pressure, you know, applied⁷ to different aspects of medical care. How is this different?

SARPATWARI: This is different because it's upstream, and this concerns the regulation of medical product, not so much the practice of medicine. And this is the first time that we've seen a judge take a drug off the market without the backing of FDA or the manufacturer itself. And so the worry here is that even before we get to the downstream sort of political and coverage⁸ decisions that you're talking about, we've already taken the drug off the market.

MARTIN: And before we let you go, as briefly⁹ as you can, what is next for the industry? Do you envision them taking more aggressive steps here? What might they do?

SARPATWARI: So to ensure stability and certainty of the pharmaceutical market, I think that all cards are on the table in terms of what industry may do. You definitely see them voicing their opinions as this case goes up on appeal. I think behind the scenes, too, you will see aggressive lobbying of Congress. And I think it's important to recognize how powerful this industry is. And it's my hope, and I think the hope of many others, that they will be quite aggressive in terms of trying to preserve the integrity of the FDA approval process.

MARTIN: That's Ameet Sarpatwari of Harvard Medical School. Thank you so much for joining us.

SARPATWARI: It's been a pleasure. Thank you.

(SOUNDBITE OF POPPY ACKROYD'S "THE CALM BEFORE")

1 pharmaceutical   

adj.药学的，药物的；药用的，药剂师的

参考例句：

• She has donated money to establish a pharmaceutical laboratory.她捐款成立了一个药剂实验室。
• We are engaged in a legal tussle with a large pharmaceutical company.我们正同一家大制药公司闹法律纠纷。

2 transcript   

n.抄本，誊本，副本，肄业证书

参考例句：

• A transcript of the tapes was presented as evidence in court.一份录音带的文字本作为证据被呈交法庭。
• They wouldn't let me have a transcript of the interview.他们拒绝给我一份采访的文字整理稿。

3 abortion   

n.流产，堕胎

参考例句：

• She had an abortion at the women's health clinic.她在妇女保健医院做了流产手术。
• A number of considerations have led her to have a wilful abortion.多种考虑使她执意堕胎。

4 activists   

n.（政治活动的）积极分子，活动家( activist的名词复数 )

参考例句：

• His research work was attacked by animal rights activists . 他的研究受到了动物权益维护者的抨击。
• Party activists with lower middle class pedigrees are numerous. 党的激进分子中有很多出身于中产阶级下层。 来自《简明英汉词典》

5 investors   

n.投资者，出资者( investor的名词复数 )

参考例句：

• a con man who bilked investors out of millions of dollars 诈取投资者几百万元的骗子
• a cash bonanza for investors 投资者的赚钱机会

6 decrying   

v.公开反对，谴责( decry的现在分词 )

参考例句：

• Soon Chinese Internet users, including government agencies, were decrying the' poisonous panda. 不久，中国网民以及政府机构纷纷谴责“影响极坏的熊猫烧香”。 来自互联网
• Democratic leaders are decrying President Bush's plan to indefinitely halt troop withdrawals from Iraq after July. 民主党领导公开谴责布什总统七月后无限停止从伊拉克撤兵的举动。 来自互联网

7 applied   

adj.应用的；v.应用，适用

参考例句：

• She plans to take a course in applied linguistics.她打算学习应用语言学课程。
• This cream is best applied to the face at night.这种乳霜最好晚上擦脸用。

8 coverage   

n.报导，保险范围，保险额，范围，覆盖

参考例句：

• There's little coverage of foreign news in the newspaper.报纸上几乎没有国外新闻报道。
• This is an insurance policy with extensive coverage.这是一项承保范围广泛的保险。

9 briefly   

adv.简单地，简短地

参考例句：

• I want to touch briefly on another aspect of the problem.我想简单地谈一下这个问题的另一方面。
• He was kidnapped and briefly detained by a terrorist group.他被一个恐怖组织绑架并短暂拘禁。