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

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And I'm Bob Doughty. This week, wetell about America's Food and Drug Administration.

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The Food and Drug Administrationaffects nearly every American every day. The F.D.A. is an agency ofthe federal government. It is responsible for enforcing the FederalFood, Drug and Cosmetic Act and several other public health laws.

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

The F.D.A. supervises feed and drugs given to animals in theUnited States. It also is responsible for labeling -- theinformation included with products. All labels describing substancesin a product must be truthful.

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

The agency makes rules for almost ninety-five thousand businessesin the United States. F.D.A. investigators inspect more than fifteenthousand manufacturing centers and farms each year. Theinvestigators make sure that products are made correctly and labeledtruthfully. Often, they will collect products for label inspectionsor testing by F.D.A. scientists.

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

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

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The federal government has not always been responsible for thequality of food and drugs in the United States. In the nineteenthcentury, American states were generally responsible for the safetyof locally-made food and drugs.

Then, Americans began pressuring federal officials to protectresources and set safety rules for the nation. The Bureau ofChemistry was made responsible for the food and drug supply. Thechief chemist at the Bureau was Harvey Wiley. For more than twentyyears, he called for a federal law to protect the public from unsafefoods.

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

In nineteen-twenty-seven, the Bureau of Chemistry was made intotwo separate agencies. One was the Food, Drug and InsecticideAdministration. Later, its name was changed to the Food and DrugAdministration. Today, the F.D.A. is part of the Department ofHealth and Human Services.

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Since the Wiley Act, Congress has passed other laws to help theFood and Drug Administration carry out its work. Yet, it has becomeharder for the F.D.A. to control medicines within the past fewyears. One reason is off-label prescriptions. This is when doctorsprescribe, or direct, patients to take medicines for unapproveduses.

For example, some patients have been given antibiotic drugs totreat viruses, or anti-depression medicines for pain. It is notuncommon for a drug to effectively treat more than one sickness.Yet, the F.D.A. usually approves drugs to treat only one disorder.

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Recently, Knight Ridder newspapers investigated the issue ofoff-label drug prescriptions in the United States. It found that thenumber of off-label prescriptions increased nearly one hundredpercent in five years. Off-label prescriptions are legal. Yet, theinvestigation estimated that at least eight thousand Americansbecame very sick after taking drugs for unapproved uses.

Some officials blame drug manufacturers for the rise in off-labelprescriptions. Sales people representing drug makers give freesupplies of their products to doctors. In turn, the doctors givethem to patients without knowing all the effects the drugs willhave.

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The F.D.A. does not test drugs before approving them for publicuse. Instead, it depends on drug manufacturers to prove the safetyof their medicines. The manufacturers often negotiate with medicalschools or private research groups to carry out tests. Drugcompanies reportedly pay millions of dollars to researchers fortheir results.

The companies argue that they own the information because theypaid for the tests. Yet, drug makers often are accused of onlyreporting findings that make their medicines look good. That meansthe public may never know about tests that find a drug useless oreven dangerous.

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The drug industry gives the Food and Drug Administration millionsof dollars every year to speed the approval of medicines. Congressreached this agreement in the nineteen-nineties. Yet, critics saythis situation makes it difficult for the F.D.A. to effectivelysupervise 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. poorlysupervised the approval of the pain medicine Vioxx. Drug maker Merckwithdrew Vioxx in September after a study showed that the drugincreased 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 unwilling to admit possible safetyproblems with drugs that it has already approved.

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Some members of Congress are calling for an independent federalagency to supervise drug safety after F.D.A. approval. The AmericanMedical Association supports the idea. The group represents doctorsin the United States.

Recently, the Journal of the American Medical Associationreported that drug maker Bayer knew one of its medicines could causea muscle disorder. Bayer withdrew the drug, Baycol, intwo-thousand-one. But the report said the company knew about theproblem three years earlier.

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American lawmakers are considering measures that would requiredrug companies to publicly list their tests. The companies alsocould be required to release their findings on the Internet. Suchpossible measures led the drug industry to develop a plan of itsown.

A trade group says it will develop a method for its members tolist their test results if they choose. However, some manufacturersoppose sharing details of their experiments because competitorscould learn trade secrets.

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The F.D.A. also faces problems controlling drugs from othercountries. A new government report says more than forty percent ofall Americans use at least one prescription drug. Sixteen percentare taking at least three.

The cost of prescription drugs is rising fast. A growing numberof state governments have launched programs to help Americans buylow-cost drugs from Canada and Europe. The states argue thatAmerican drug prices are unfair and harmful to state-assistedhealthcare programs.

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The F.D.A. says it cannot guarantee the safety of medicines fromforeign markets. It argues that some imported drugs may be not safeor effective. The Bush administration and American drug companiesalso oppose foreign imports. But, the American Medical Associationsupports the idea of imported drugs if the federal government canguarantee the safety of the medicines.

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

These are just some of the issues facing the Food and DrugAdministration. This influential agency is expected to deal withthese and many other concerns in the months to come.

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

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