VOA常速英语2008年-Voucher Program to Encourage New Drugs for Trop

By Jessica Berman
Washington
01 April 2008

For the past 50 years, the development of new drugs to treat tropical diseases that affect nearly one billion people has languished¹ because it has not been profitable for drug manufacturers in the West. But that could change with a so-called voucher² program that will give U.S. drug manufacturers a major financial incentive³ to develop drugs for illnesses that are rarely seen in developed countries. VOA's Jessica Berman reports.

Last year, U.S. drug makers⁴ were handed what some say could be a huge financial benefit.

The U.S. Congress gave the Food and Drug Administration permission to issue what it calls a voucher to any pharmaceutical⁵ company that is granted regulatory approval for a new tropical medicine.

The list of eligible⁶ diseases includes tuberculosis⁷, malaria⁸, and schistosomiasis along with other illnesses caused by worms and parasites⁹.

The voucher will give a manufacturer expedited consideration of any experimental medicine that the company believes could become what is known in the industry as a "blockbuster" drug. Previous blockbusters include Viagra for erectile dysfunction and Prozac for the treatment of depression.

Timothy Cote is director of the FDA's office that oversees¹⁰ the approval of products for diseases affecting less than 200,000 people in the United States.

"Drug sales for [a] typical blockbuster can extend between $3 billion and $10 billion to $12 billion, that's with a 'b,' billion dollars per year in sales," Cote. "So, making it faster to review those has a financial value if you have $5 billion in sales and you can speed the review process up by six months, well that's $2.5 billion, which is a lot of money."

The average review process by the FDA takes between 10 and 18 months. Under the voucher program, the U.S. regulatory agency will consider applications seeking approval for blockbuster drugs within six months.

Cote says the expedited review in no way compromises safety.

"It doesn't change the review," he said. "It doesn't guarantee an approval. It only says that we will speed review of some other drug. Now, this voucher will only be most useful for blockbuster drugs that have large market potential in the future."

Despite such guarantees, Harvard University Medical School professor Aaron Kesselheim thinks racing¹¹ to develop drugs for tropical illnesses in order to get a voucher is a bad idea.

Kesselheim points to a just-released study by colleagues at Harvard which found that U.S. regulators, feeling the pressure to approve new drugs in a shorter time frame, approved medications that were five times more likely to be withdrawn¹² from the market for safety reasons.

The researchers also found that more than four percent of new drugs that found their way to consumers had to have a stern, black box safety warning added to the packaging.

Kesselheim says the financial lure¹³ of a voucher may attract companies with no experience in developing drugs for tropical diseases.

"A company that might be really good at making cardiovascular medications is going to try to get faster reviews to enter the tropical disease development world and might not be as skilled as other manufacturers who might be focused on anti-infective products," said Kesselheim.

James Geraghty is Senior Vice¹⁴ President of Genzyme Corporation, a biotechnology firm that develops new drugs and stands to benefit from the voucher program.

Geraghty says the FDA's program will not compromise the safety standards of the drug manufacturing industry.

"Expedited review does not involve, we don't ever intend it to involve, any lowering of standards," he said. "It's just a prioritization system that provides for prioritization and acceleration¹⁵ of review for important public health reasons, not in any way a reducing of the standards of that review."

Harvard's Kesselheim thinks there are better ways to encourage the development of new drugs for neglected diseases, including front end commitments from developing countries to Western drug makers to purchase large quantities of tropical medicines once they are developed.

The voucher program is scheduled to take effect in September.

1 languished   

长期受苦( languish的过去式和过去分词 )； 受折磨； 变得（越来越）衰弱； 因渴望而变得憔悴或闷闷不乐

参考例句：

• Our project languished during the holidays. 我们的计划在假期间推动得松懈了。
• He languished after his dog died. 他狗死之后，人憔悴了。

2 voucher   

n.收据；传票；凭单，凭证

参考例句：

• The government should run a voucher system.政府应该施行凭证制度。
• Whenever cash is paid out,a voucher or receipt should be obtained.无论何时只要支付现金，就必须要有一张凭据或者收据。

3 incentive   

n.刺激；动力；鼓励；诱因；动机

参考例句：

• Money is still a major incentive in most occupations.在许多职业中，钱仍是主要的鼓励因素。
• He hasn't much incentive to work hard.他没有努力工作的动机。

4 makers   

n.制造者，制造商（maker的复数形式）

参考例句：

• The makers of the product assured us that there had been no sacrifice of quality. 这一产品的制造商向我们保证说他们没有牺牲质量。
• The makers are about to launch out a new product. 制造商们马上要生产一种新产品。 来自《简明英汉词典》

5 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。

6 eligible   

adj.有条件被选中的；(尤指婚姻等)合适(意)的

参考例句：

• He is an eligible young man.他是一个合格的年轻人。
• Helen married an eligible bachelor.海伦嫁给了一个中意的单身汉。

7 tuberculosis   

n.结核病，肺结核

参考例句：

• People used to go to special health spring to recover from tuberculosis.人们常去温泉疗养胜地治疗肺结核。
• Tuberculosis is a curable disease.肺结核是一种可治愈的病。

8 malaria   

n.疟疾

参考例句：

• He had frequent attacks of malaria.他常患疟疾。
• Malaria is a kind of serious malady.疟疾是一种严重的疾病。

9 parasites   

寄生物( parasite的名词复数 )； 靠他人为生的人； 诸虫

参考例句：

• These symptoms may be referable to virus infection rather than parasites. 这些症状也许是由病毒感染引起的，而与寄生虫无关。
• Kangaroos harbor a vast range of parasites. 袋鼠身上有各种各样的寄生虫。

10 oversees   

v.监督，监视( oversee的第三人称单数 )

参考例句：

• She oversees both the research and the manufacturing departments. 她既监督研究部门又监督生产部门。 来自《简明英汉词典》
• The Department of Education oversees the federal programs dealing with education. 教育部监管处理教育的联邦程序。 来自互联网

11 racing   

n.竞赛，赛马；adj.竞赛用的，赛马用的

参考例句：

• I was watching the racing on television last night.昨晚我在电视上看赛马。
• The two racing drivers fenced for a chance to gain the lead.两个赛车手伺机竞相领先。

12 withdrawn   

vt.收回；使退出；vi.撤退，退出

参考例句：

• Our force has been withdrawn from the danger area.我们的军队已从危险地区撤出。
• All foreign troops should be withdrawn to their own countries.一切外国军队都应撤回本国去。

13 lure   

n.吸引人的东西，诱惑物；vt.引诱，吸引

参考例句：

• Life in big cities is a lure for many country boys.大城市的生活吸引着许多乡下小伙子。
• He couldn't resist the lure of money.他不能抵制金钱的诱惑。

14 vice   

n.坏事；恶习；[pl.]台钳，老虎钳；adj.副的

参考例句：

• He guarded himself against vice.他避免染上坏习惯。
• They are sunk in the depth of vice.他们堕入了罪恶的深渊。

15 acceleration   

n.加速，加速度

参考例句：

• All spacemen must be able to bear acceleration.所有太空人都应能承受加速度。
• He has also called for an acceleration of political reforms.他同时呼吁加快政治改革的步伐。