Tagged Articles

Food and Drug Administration 233 articles

Consumer group calls FDA’s unwillingness to ban latex “reckless”

Surgical and patient examination gloves that have cornstarch powder on them or are made of natural latex rubber pose a serious threat to patients and health care workers and must be banned said Public Citizen, a national, nonprofit consumer advocacy organization, in a petition filed Monday with the Food and Drug Administration (FDA). Many people are chronically allergic to latex rubber. Health care workers can experience serious or life-threatening allergic reactions when they wear latex gloves or when they inhale the cornstarch powder bound to latex proteins that has been released from latex gloves worn by others. Inhaling the cornstarch ... Read More

Aggressive marketing of Gardasil plays on public fear of cancer

A recent lecture presented by Southern Methodist University’s Cary M. Maguire Center for Ethics and Public Responsibility, in collaboration with SMU’s Department of Anthropology, examined the ethical questions of pharmaceutical company Merck’s marketing of its Gardasil vaccine. The drug, fast-tracked for approval in 2006 by the U.S. Food and Drug Administration, was aggressively marketed as a preventive for cervical cancer. Gardasil was recommended for girls beginning as young as age 9, and presented as an “anti-cancer vaccine.” The drug actually protects against four of hundreds of strains of human papillomavirus (HPV), two of which are high risk, responsible for about ... Read More

Lack of testing, FDA shortcuts made DePuy hip recipients guinea pigs

The term “guinea pig” is often used jokingly by patients who feel that their medical treatment is underdeveloped or experimental. But when it comes to the Food and Drug Administration’s fast-track approval of certain medical devices such as DePuy’s ASR XL Acetabular and ASR Hip Resurfacing implants, “guinea pig” is sometimes an apt description. The FDA often approves medical devices without requiring proper clinical testing if the manufacturer demonstrates that the new unproven device is substantially similar to an already-approved one. This process, called the 510k process, spares the manufacturer thousands of dollars in clinical testing and usually takes just ... Read More

FDA approves Gardasil for use in preventing anal cancer

The U.S. Food and Drug Administration (FDA) has approved the use of the Gardasil vaccine for the prevention of anal cancer. Previously, the drug was approved only for use in girls and young women, for the prevention of cervical cancer. Gardasil targets the human papillomavirus (HPV), a sexually transmitted virus that can cause cervical cancer. Recent studies have also show the virus can cause anal cancer. The approval expands the audience for the Merck & Col. manufactured drug to include all people – boys and girls – ages 9 through 26. Gardasil protects against four kinds of HPV – 6, ... Read More

Historical food safety bill passes Senate

The U.S. Senate today passed a sweeping overhaul of the country’s food safety system, a move triggered by the steadily growing number of food-borne illness outbreaks occurring throughout the country. If signed into law, the Food Safety Modernization Act will strengthen the Food and Drug Administration’s powers to prevent contaminated foods from entering the nation’s food supply. Consumer advocates, safety experts, and a number of bipartisan legislators pushed for the overhaul, which will affect about 80 percent of the nation’s food supply, including fresh fruits and vegetables, eggs, dairy products and processed foods that do not contain meat. Meat supplies ... Read More

FDA awaits advisory panel decision about Gardasil vaccine for boys

An advisory panel to the U.S. Food & Drug Administration (FDA) is expected to decide by the end of the year whether it will recommend expanding the use of the HPV vaccine, Gardasil, for use in boys and young men. The drug, which targets the Human Papillomavirus and is currently recommended for use in girls and young women for the prevention of cervical cancer, is currently approved, but not recommended, for young men to prevent genital warts. If the advisory panel finds there is sufficient clinical data to show that the vaccine would prevent anal lesions and anal cancer in ... Read More

Graphic safety labels will soon appear on cigarette packages

By next fall, 50 percent of the surface area on cigarette packages may be covered with graphic warning labels designed to discourage nonsmokers from picking up the habit and encourage smokers to quit. Until then, the Food and Drug Administration (FDA) has the enviable task of choosing from 36 different designs. The choices, found on the FDA’s website, range from cartoons of smokers dangling from puppet’s strings to shocking images of a man smoking from a tracheostomy tube inserted into his throat, and a dead man lying on a stretcher with the warning “Smoking can kill you.” The labels are ... Read More

Malaysian government set to vaccinate girls with Gardasil

SM Mohammed Idris, president of the Consumers Association of Penang, recently wrote an opinion piece for the Malaysia Kini website, asking that the government reconsider its decision to vaccinate all 13-year-old girls in the country with Gardasil or Cervarix. According to the column, the country’s Ministry of Health (MOH) will spend RM 150 million annually for the vaccinations, which will affect about 300,000 girls. Idris warns the vaccine is “unnecessary, unscientific and unsafe.” Gardasil, manufactured by Merck & Co., and Cervarix, manufactured by GlaxoSmithKline, are promoted for the prevention of the human papillomavirus (HPV), a sexually transmitted virus linked to ... Read More

FDA fights rapid rise in egg-related illness with new safety rules

Responding to a sharp increase in the number of illnesses linked to contaminated eggs, the U.S. Food and Drug Administration has introduced tougher safety requirements for large-scale egg producers. The agency says that the new rules can eliminate nearly 80,000 illnesses and save 30 lives every year. The measures target the spread of Salmonella Enteritidis bacteria throughout egg producing facilities. The salmonella bacteria frequently contaminate eggs and the products in which they are used. Since May 2010, The Centers for Disease Control and Prevention have identified a nationwide, four-fold increase in the number of Salmonella Enteritidis isolates reported by state and ... Read More

FAA let Northwest Airlines ignore safety rules, government report finds

Federal regulatory agencies have come under fire recently for their “cozy relationships” with large corporations; the Food and Drug Administration, the National Highway Traffic Safety Administration, and the now-defunct Minerals Management Service have all been targeted for reform by the Obama Administration for their failure to enforce safety rules and regulations. Now the Federal Aviation Administration is being investigated for turning a blind eye on Northwest Airlines while it ignored federal safety regulations for more than a decade. According to a new report by the Transportation Department’s inspector general’s office, the allegations were first made by Mark Lund, an FAA ... Read More