SCIENCE IN THE NEWS - The Food and Drug Administration

SCIENCE IN THE NEWS - The Food and Drug Administration
By Jill Moss¹

Broadcast: Tuesday, December 21, 2004

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VOICE ONE:

This is SCIENCE IN THE NEWS, in VOA Special English. I'm Sarah Long.

VOICE TWO:

 
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And I'm Bob Doughty³. This week, we tell about America's Food and Drug Administration.

VOICE ONE:

 
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The Food and Drug Administration affects nearly every American every day. The F.D.A. is an agency of the federal government. It is responsible for enforcing the Federal Food, Drug and Cosmetic⁴ Act and several other public health laws.

The F.D.A. is responsible the safety of most food products and medicines. It guarantees that medical devices and biological products are safe and effective. It also guarantees the safety of beauty products and the country's blood supply and beauty products.

The F.D.A. supervises feed and drugs given to animals in the United States. It also is responsible for labeling -- the information included with products. All labels describing substances in a product must be truthful⁵.

VOICE TWO:

The F.D.A. has about nine thousand employees. They supervise the manufacture, import, transport, storage and sale of about one million-million dollars worth of products each year. This amount represents one-fourth of all money spent by American citizens each year.

The agency makes rules for almost ninety-five thousand businesses in the United States. F.D.A. investigators⁶ inspect more than fifteen thousand manufacturing centers and farms each year. The investigators make sure that products are made correctly and labeled truthfully. Often, they will collect products for label inspections⁷ or testing by F.D.A. scientists.

VOICE ONE:

The Food and Drug Administration has several choices if a company is found violating any of the laws the agency enforces. F.D.A. officials can urge the company to correct the problem. Or, they can legally remove, or recall, a bad product from the marketplace. About three thousand products are recalled in the United States each year.

In addition, F.D.A. investigators will seize products if they appear to be unfit for public use. About thirty thousand shipments of imported goods are seized at American ports every year.

VOICE TWO:

The federal government has not always been responsible for the quality of food and drugs in the United States. In the nineteenth century, American states were generally responsible for the safety of locally-made food and drugs.

Then, Americans began pressuring federal officials to protect resources and set safety rules for the nation. The Bureau of Chemistry was made responsible for the food and drug supply. The chief chemist at the Bureau was Harvey Wiley. For more than twenty years, he called for a federal law to protect the public from unsafe foods.

VOICE ONE:

Finally, in nineteen-oh-six, President Theodore Roosevelt signed the Food and Drugs Act into law. The measure became known as the Wiley Act. It banned the transport and sale of unclean or falsely labeled foods, drinks and drugs.

In nineteen-twenty-seven, the Bureau of Chemistry was made into two separate agencies. One was the Food, Drug and Insecticide Administration. Later, its name was changed to the Food and Drug Administration. Today, the F.D.A. is part of the Department of Health and Human Services.

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VOICE TWO:

Since the Wiley Act, Congress has passed other laws to help the Food and Drug Administration carry out its work. Yet, it has become harder for the F.D.A. to control medicines within the past few years. One reason is off-label prescriptions⁹. This is when doctors prescribe, or direct, patients to take medicines for unapproved uses.

For example, some patients have been given antibiotic¹⁰ drugs to treat viruses, or anti-depression medicines for pain. It is not uncommon¹¹ for a drug to effectively treat more than one sickness. Yet, the F.D.A. usually approves drugs to treat only one disorder¹².

VOICE ONE:

Recently, Knight¹³ Ridder newspapers investigated the issue of off-label drug prescriptions in the United States. It found that the number of off-label prescriptions increased nearly one hundred percent in five years. Off-label prescriptions are legal. Yet, the investigation¹⁴ estimated that at least eight thousand Americans became very sick after taking drugs for unapproved uses.

Some officials blame drug manufacturers for the rise in off-label prescriptions. Sales people representing drug makers¹⁶ give free supplies of their products to doctors. In turn, the doctors give them to patients without knowing all the effects the drugs will have.

VOICE TWO:

The F.D.A. does not test drugs before approving them for public use. Instead, it depends on drug manufacturers to prove the safety of their medicines. The manufacturers often negotiate with medical schools or private research groups to carry out tests. Drug companies reportedly pay millions of dollars to researchers for their results.

The companies argue that they own the information because they paid for the tests. Yet, drug makers often are accused of only reporting findings that make their medicines look good. That means the public may never know about tests that find a drug useless or even dangerous.

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VOICE ONE:

The drug industry gives the Food and Drug Administration millions of dollars every year to speed the approval of medicines. Congress reached this agreement in the nineteen-nineties. Yet, critics say this situation makes it difficult for the F.D.A. to effectively supervise the drug industry.

Doctor Richard Graham is a drug safety expert with the agency. Last month, he told a Senate committee that the F.D.A. poorly supervised the approval of the pain medicine Vioxx. Drug maker¹⁵ Merck withdrew Vioxx in September after a study showed that the drug increased the risk of heart attacks and strokes.

Doctor Graham said his agency denied evidence Vioxx was unsafe. He also said the F.D.A. is unwilling¹⁷ to admit possible safety problems with drugs that it has already approved.

VOICE TWO:

Some members of Congress are calling for an independent federal agency to supervise drug safety after F.D.A. approval. The American Medical Association supports the idea. The group represents doctors in the United States.

Recently, the Journal of the American Medical Association reported that drug maker Bayer knew one of its medicines could cause a muscle disorder. Bayer withdrew the drug, Baycol, in two-thousand-one. But the report said the company knew about the problem three years earlier.

VOICE ONE:

American lawmakers are considering measures that would require drug companies to publicly list their tests. The companies also could be required to release their findings on the Internet. Such possible measures led the drug industry to develop a plan of its own.

A trade group says it will develop a method for its members to list their test results if they choose. However, some manufacturers oppose sharing details of their experiments because competitors could learn trade secrets.

VOICE TWO:

The F.D.A. also faces problems controlling drugs from other countries. A new government report says more than forty percent of all Americans use at least one prescription⁸ drug. Sixteen percent are taking at least three.

The cost of prescription drugs is rising fast. A growing number of state governments have launched programs to help Americans buy low-cost drugs from Canada and Europe. The states argue that American drug prices are unfair and harmful to state-assisted healthcare programs.

VOICE ONE:

The F.D.A. says it cannot guarantee the safety of medicines from foreign markets. It argues that some imported drugs may be not safe or effective. The Bush administration and American drug companies also oppose foreign imports. But, the American Medical Association supports the idea of imported drugs if the federal government can guarantee the safety of the medicines.

Some lawmakers support price controls on prescription drugs. Others believe such controls would affect company profits needed for the development of new medicines.

These are just some of the issues facing the Food and Drug Administration. This influential¹⁸ agency is expected to deal with these and many other concerns in the months to come.

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VOICE TWO:

This program was written by Jill Moss. Cynthia Kirk was our producer. Our engineer was Dwayne Collins. I'm Bob Doughty.

VOICE ONE:

And I'm Sarah Long. Join us again next week for Science in the News in VOA Special English.

1 moss   

n.苔，藓，地衣

参考例句：

• Moss grows on a rock.苔藓生在石头上。
• He was found asleep on a pillow of leaves and moss.有人看见他枕着树叶和苔藓睡着了。

2 graphic   

adj.生动的，形象的，绘画的，文字的，图表的

参考例句：

• The book gave a graphic description of the war.这本书生动地描述了战争的情况。
• Distinguish important text items in lists with graphic icons.用图标来区分重要的文本项。

3 doughty   

adj.勇猛的，坚强的

参考例句：

• Most of successful men have the characteristics of contumacy and doughty.绝大多数成功人士都有共同的特质：脾气倔强，性格刚强。
• The doughty old man battled his illness with fierce determination.坚强的老人用巨大毅力与疾病作斗争。

4 cosmetic   

n.化妆品；adj.化妆用的；装门面的；装饰性的

参考例句：

• These changes are purely cosmetic.这些改变纯粹是装饰门面。
• Laughter is the best cosmetic,so grin and wear it!微笑是最好的化妆品，所以请尽情微笑吧！

5 truthful   

adj.真实的，说实话的，诚实的

参考例句：

• You can count on him for a truthful report of the accident.你放心，他会对事故作出如实的报告的。
• I don't think you are being entirely truthful.我认为你并没全讲真话。

6 investigators   

n.调查者，审查者( investigator的名词复数 )

参考例句：

• This memo could be the smoking gun that investigators have been looking for. 这份备忘录可能是调查人员一直在寻找的证据。
• The team consisted of six investigators and two secretaries. 这个团队由六个调查人员和两个秘书组成。 来自《简明英汉词典》

7 inspections   

n.检查( inspection的名词复数 )；检验；视察；检阅

参考例句：

• Regular inspections are carried out at the prison. 经常有人来视察这座监狱。
• Government inspections ensure a high degree of uniformity in the standard of service. 政府检查确保了在服务标准方面的高度一致。 来自《简明英汉词典》

8 prescription   

n.处方，开药；指示，规定

参考例句：

• The physician made a prescription against sea- sickness for him.医生给他开了个治晕船的药方。
• The drug is available on prescription only.这种药只能凭处方购买。

9 prescriptions   

药( prescription的名词复数 )； 处方； 开处方； 计划

参考例句：

• The hospital of traditional Chinese medicine installed a computer to fill prescriptions. 中医医院装上了电子计算机来抓药。
• Her main job was filling the doctor's prescriptions. 她的主要工作就是给大夫开的药方配药。

10 antibiotic   

adj.抗菌的；n.抗生素

参考例句：

• The doctor said that I should take some antibiotic.医生说我应该服些用抗生素。
• Antibiotic can be used against infection.抗菌素可以用来防止感染。

11 uncommon   

adj.罕见的，非凡的，不平常的

参考例句：

• Such attitudes were not at all uncommon thirty years ago.这些看法在30年前很常见。
• Phil has uncommon intelligence.菲尔智力超群。

12 disorder   

n.紊乱，混乱；骚动，骚乱；疾病，失调

参考例句：

• When returning back,he discovered the room to be in disorder.回家后，他发现屋子里乱七八糟。
• It contained a vast number of letters in great disorder.里面七零八落地装着许多信件。

13 knight   

n.骑士，武士；爵士

参考例句：

• He was made an honourary knight.他被授予荣誉爵士称号。
• A knight rode on his richly caparisoned steed.一个骑士骑在装饰华丽的马上。

14 investigation   

n.调查，调查研究

参考例句：

• In an investigation,a new fact became known, which told against him.在调查中新发现了一件对他不利的事实。
• He drew the conclusion by building on his own investigation.他根据自己的调查研究作出结论。

15 maker   

n.制造者，制造商

参考例句：

• He is a trouble maker，You must be distant with him.他是个捣蛋鬼，你不要跟他在一起。
• A cabinet maker must be a master craftsman.家具木工必须是技艺高超的手艺人。

16 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》

17 unwilling   

adj.不情愿的

参考例句：

• The natives were unwilling to be bent by colonial power.土著居民不愿受殖民势力的摆布。
• His tightfisted employer was unwilling to give him a raise.他那吝啬的雇主不肯给他加薪。

18 influential   

adj.有影响的，有权势的

参考例句：

• He always tries to get in with the most influential people.他总是试图巴结最有影响的人物。
• He is a very influential man in the government.他在政府中是个很有影响的人物。