Voa Science Report - Safety Concerns Put Pressure on US Food and Drug Officials, Congress

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ONE: This is SCIENCE IN THE NEWS, in VOA English. I'm Steve Ember. VOICE TWO: And I'm Barbara . This week, we tell about America's Food and Drug . (MUSIC) VOICE ONE: The Food and Drug Administration is agency of the federal government. The agency enforces the Food, Drug and Cosmetic Act and several other public laws. The FDA... is responsible for the safety of food products and medicines. It guarantees that medical devices biological products are safe and effective. It also guarantees safety of beauty products and the countrys blood supply. FDA... supervises feed and drugs given to animals in United States. It also is responsible for labeling ---- information included with products. All labels describing substances in product must be truthful. VOICE TWO: The FDA... has nine thousand employees. They supervise the manufacture, import, transport, and sale of about one million million dollars worth products each year. This amount represents one-fourth of all spent by Americans each year. The agency makes rules almost ninety thousand businesses in the United States. FDA... inspect more than sixteen thousand manufacturing centers and farms year. The investigators make sure that products are made and labeled truthfully. Often, they will collect products for inspections or testing by FDA... scientists. VOICE ONE: The and Drug Administration has several choices if a company found violating any of the laws the agency enforces. ... officials can urge the company to correct the problem. , they can legally remove, or recall, a bad product the marketplace. In addition, FDA... investigators will seize products they appear to fail requirements for public use. About thousand shipments of imported goods are seized at American every year. VOICE TWO: The federal government has not been responsible for the quality of food and medicines the United States. In the nineteenth century, individual states generally responsible for the safety of locally-made food and . Then, Americans began pressuring the federal government to protect and set safety rules. The Bureau of Chemistry was responsible for the food and drug supply. The chief at the Bureau was Harvey Wiley. For more than years, he called for a federal law to protect public from unsafe foods. VOICE ONE: Finally, in nineteen-oh-six--, Theodore Roosevelt signed the Food and Drugs Act into . The measure became known as the Wiley Act. It the transport and sale of unclean or falsely labeled , drinks and drugs. In nineteen twenty-seven-, the Bureau of was made into two separate agencies. One was the , Drug and Insecticide Administration. Later, its name was changed the Food and Drug Administration. Today, the FDA... is of the Department of Health and Human Services. (MUSIC) TWO: Since the Wiley Act, Congress has passed other to help the Food and Drug Administration carry out work. Yet, it has become harder for the FDA... control medicines within the past few years. One reason off-label prescriptions. This is when doctors prescribe, or direct, to take medicines for unapproved uses. For example, some have been given antibiotic drugs to treat viruses, or medicines for pain. It is not uncommon for a to effectively treat more than one health disorder. Yet, FDA... usually approves drugs to treat only one disorder. ONE: A recent study investigated the use of off-label in the United States. The Archives for Internal Medicine on the investigation. Researchers studied information about the drugs prescribed by American doctors in two thousand one. They that twenty-one percent of those prescriptions were meant to medical conditions for which the drugs lacked FDA... approval. three of every four of the prescriptions were for conditions for which there were little evidence of the safety or effectiveness. VOICE TWO: Off-label prescriptions are legal. , they carry unknown risks. Several thousand Americans are believed become very sick every year after taking drugs for uses. Some officials blame drug manufacturers for the rise off-label prescribing. Sales people representing drug makers give free of their products to doctors. The doctors then give to patients without knowing all the effects the drugs have. VOICE ONE: The FDA... does not directly test before approving them for public use. Instead, it depends drug manufacturers to prove the safety of their medicines. manufacturers often negotiate with medical schools or private groups carry out tests. Drug companies reportedly pay millions of to researchers for their results. The companies argue that own the information because they paid for the tests. , drug makers often are accused of only reporting findings make their medicines look good. That means the public never know about tests that find a drug useless even dangerous. (MUSIC) VOICE TWO: The drug industry gives Food and Drug Administration millions of dollars every year speed the approval of medicines. Congress reached this agreement the nineteen-nineties-. Yet, critics say this situation makes it for the FDA... to effectively supervise drug companies. The ... has also faced trouble with some drugs it approved. two thousand four, drug maker Merck announced a worldwide of its pain medicine Vioxx. Merck acted after a showed that Vioxx increased the risk of heart attacks strokes. VOICE ONE: Recently, more questions have been raised the drug approval process. Researchers in the American state Ohio reported last month that a drug commonly used treat diabetes might increase the risk of heart attacks. seven million people worldwide use the drug, Avandia. Its is GlaxoSmithKline. The report led to a congressional investigation why the FDA... had delayed warnings about Avandia. Officials the agency had suggested stronger safety warnings for the last year. But only recently did the head of FDA... call for stronger warnings for Avandia and a diabetes drug, Actos. He also said the agency is conflicting studies of Avandia to fully establish its effects patients. VOICE TWO: The Vioxx and Avandia incidents have congressional concerns about the effectiveness of the FDA... Last , the Senate approved a bill that would expand the of the agency to enforce drug safety. The bill give the FDA... power to control advertisements and restrict use of medicines found to increase health risks. The would also give the agency power to order changes labeling. Drug companies currently can delay changes on their for months. VOICE ONE: The Senate bill would expand FDAs ability to require manufacturers to study the safety medicines after they have been approved. It also would them to publicly list drug tests and their results. kind of government-operated list would make it difficult for to hide evidence of safety problems. Parts of the bill are supported in the House of Representatives. Political say a drug safety bill is likely to become later this year. VOICE TWO: Some people believe the ... needs to improve its rules for food safety. Millions Americans become sick each year after eating unclean food products containing harmful substances. Public health concerns increased earlier year when food products from China sickened and killed animals in the United States. The products contained an chemical, melamine. Several members of Congress have proposed creation a single agency responsible for food safety. VOICE ONE: are just some of the issues facing the Food Drug Administration. The agency is expected to deal with and other concerns in the months to come. (MUSIC) TWO: This program was written by Jill Moss. Brianna was our producer. Im Barbara Klein. VOICE ONE: And Steve Ember. Join us again at this time next for more news about science in Special English on Voice of America.

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