Broadcast: 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:
And I'm Bob Doughty. This week, we tell about America’s Food and Drug Administration.
VOICE ONE:
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 Cosmetic 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 truthful.
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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. investigators 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 inspections or testing by F.D.A. scientists.
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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.
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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.
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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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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 prescriptions. This is when doctors prescribe, or direct, patients to take medicines for unapproved uses.
For example, some patients have been given antibiotic drugs to treat viruses, or anti-depression medicines for pain. It is not uncommon 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 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 investigation 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 makers 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.
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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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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 maker 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 unwilling to admit possible safety problems with drugs that it has already approved.
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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.
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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.
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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 prescription 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.
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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 influential 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.