Aug 12, 2009 | 5
Two leaders at the U.S. Food and Drug Administration (FDA) have recently found themselves in hot water at the agency. The director of drug approval has been named in an ethics investigation and a head medical device regulator has resigned.
The agency's director of the medical device division, Daniel Schultz, resigned yesterday after 15 years with the group. He had been accused of siding with industry suppliers, against scientific recommendations, during his five-year tenure leading the division, the Wall Street Journal reported today.
Schultz was involved in several controversial approvals, including a ReGen Biologics device used in knee surgery, which, according the Journal, had been permitted despite years of opposition from reviewers and scientists. Agency researchers reportedly described internal pressure to approve devices despite questionable safety or efficacy.
Jul 24, 2009 | 45
Those who like to get their nicotine fix electronically will be disappointed to hear that a U.S. Food and Drug Administration report earlier this week found that electronic cigarettes, or "e-cigarettes," contain carcinogens and toxic chemicals such as diethylene glycol, an ingredient used in antifreeze.
The draw of e-cigarettes is supposed to be their ability to let smokers regulate their nicotine intake (nicotine is sold in disposable cartridges containing differing amounts) while producing water vapor, as opposed to secondhand smoke. The smoker inhales doses of nicotine vaporized with the help of a solvent such as propylene glycol. E-cigarettes, which were all the rage at this year's Consumer Electronics Show (CES) in Las Vegas, are battery-operated plastic tubes made to look like cigarettes (or in some cases cigars and pipes).
Jul 22, 2009 | 11
The Food Safety Enhancement Act (H.R. 2749), a bill currently being moved through the House of Representatives and gaining attention over the summer, could give the U.S. Food and Drug Administration (FDA) authority to regulate the way animals are raised on farms—a prospect that worries many small farmers.
The bill brings to light the challenges of determining which government agency should be regulating which process. And generally, farmers are more comfortable with the U.S. Department of Agriculture (USDA) governing farm production policies.
Many farmers believe that the FDA should regulate food and not necessarily the living organisms on the farm. One of the biggest concerns among farmers is the lack of FDA expertise regarding on-farm production, as pointed out by North Carolina Farm Bureau President Larry Wooten during his testimony at a June 17 congressional hearing on the bill. The Farm to Consumer News Web site reports that organic supporters are worried about burdensome and expensive regulations that the “food safety police,” as they call the FDA, might devise and enforce.
Jul 14, 2009 | 9
More than 50 years ago, the U.S. Food and Drug Administration (FDA) approved the addition of antibiotics to livestock feed to reduce disease that can occur from dense living conditions and high-protein diets. Yesterday, the FDA announced its aim to withdraw that approval and stop all nontherapeutic germ-fighting in chickens, pigs and cows.
The ban would cover seven classes of antibiotics that the FDA considers “highly” or “critically” important components of the human arsenal against bacteria. “Trends toward increasing numbers of infection and increasing drug resistance show no sign of abating,” Joshua Sharfstein, principal deputy commissioner of the FDA explained in written testimony to the House of Representatives' Committee on Rules.
May 1, 2009 | 2
You might have thought that Botox, the popular drug made from botulinum toxin, was simple spot treatment for everything from frown lines to muscle spasms. But studies have shown that the effects of the drugs can actually spread throughout the body, causing difficulty swallowing and breathing and even death. Acting on this mounting data, the U.S. Food and Drug Administration (FDA) announced strict new labeling requirements for Botox and similar products yesterday, reports The New York Times.
The drugs are manufactured from the botulinum toxin, which is a toxic protein associated with botulism, the disease that can result in paralysis and death. In a controlled dose and purified form, the toxin was approved by the FDA in 1989 to treat crossed eyes and eyelid twitching, in 2000 to treat abnormal pain or twitching in the neck (cervical dystonia) and in 2002 to treat frown lines. It's also approved for use to mitigate excessive armpit sweating.
Apr 13, 2009 | 1
At least seven states are considering banning bisphenol A (BPA), a chemical found in baby bottles and other plastic products that U.S. federal regulators have said is safe but has been banned in Canada because of links to health problems including heart disease and diabetes.
Lawmakers in California, Hawaii, Illinois, Maryland, Massachusetts, Michigan and Minnesota have proposed restrictions on BPA, the Milwaukee Journal-Sentinel reports – part of a periodic series of stories the newspaper is running on the chemical also found in the lining of cans.
The proposed state measures would ban BPA in baby bottles, baby formula cans, cups and other products for kids, according to the newspaper. The House and Senate are also considering bills, introduced by Rep. Edward Markey (D-Mass.) and Sens. Dianne Feinstein (D-Calif.) and Chuck Schumer (D-N.Y.), that would slap a federal ban on use of BPA in all food and drink containers.
Apr 10, 2009 | 2
The company whose salmonella-tainted peanut products made 691 people sick and may have killed nine others has been fined $14.6 million.
The Texas Department of State Health Services yesterday fined Plainview Peanut Corp. — a plant owned by the Peanut Corporation of America (PCA), the company at the center of the salmonella outbreak — for what the agency described as unsanitary conditions and contamination of its goods, as well as illnesses and operating for nearly four years without a food manufacturer’s license from the state. State health inspectors in February discovered dead rodents, waste and bird feathers in a crawl space above the plant's production area. PCA filed for bankruptcy a day after the stomach-turning findings were announced.
Apr 9, 2009 | 2
The Food and Drug Administration (FDA) has signed off on Coartem, an anti-malaria drug whose active ingredient is a Chinese herb.
The drug, made by Swiss-based Novartis, is a combination of artemether (a derivative of the herb artemisinin) and lumefantrine (a broad-spectrum antibiotic). The three-day medication, already available in 80 other countries, cures more than 96 percent of malaria cases, including those in areas where the parasite has become resistant to chloroquine, which for decades was a widely used preventive and treatment.
“Because of concerns about drug resistance with currently available drug therapy, it will benefit patients to have another treatment option for malaria available,” Edward Cox, director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research, said in a statement released after yesterday's decision.
Apr 8, 2009 | 1
The Food and Drug Administration (FDA) has green-lighted a test that can quickly determine whether a person is infected with deadly avian flu.
The FDA yesterday approved the AVantage A/H5N1 Flu Test, made by Sunnyvale, Calif.-based Arbor Vita Corp. The nose or throat swab can detect the infection in less than 40 minutes, the agency said; previous diagnostic tests took up to four hours.
"This test is an important tool to help quickly identify emerging influenza A/H5N1 infections and reduce exposure to large populations," Daniel Schultz, director of the FDA's Center for Devices and Radiological Health, said in a statement. "The clearance of this test represents a major step toward protecting the public from the threat of pandemic flu."
Apr 2, 2009 | 7
The House today approved a bill that would for the first time give the U.S. Food and Drug Administration (FDA) the authority to regulate tobacco products.
The legislation, sponsored by Rep. Henry Waxman (D–Calif.), passed by a 298-112 vote, culminating a nearly decade-long battle by anti-smoking advocates to grant the FDA regulatory power over the industry. The bill, the Family Smoking Prevention and Tobacco Control Act, would empower the agency to approve or nix new products and bars companies from adding fruit and other flavors to cigarettes that critics say are aimed at attracting—and hooking—young smokers.
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