The Food and Drug Administration

Reading audio



2004-12-20

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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.

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. 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.

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 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.

VOICE ONE:

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.

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 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.

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 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.

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 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.