Friday, June 22, 2012

Alphabet Agency: FDA Feedbag

Who knows what could be in that burger you are eating.... 

"FDA seeks limits to antibiotics in animal feed; Plan would ask for cooperation from drug firms" by Dina ElBoghdady  |  Washington Post, April 12, 2012

WASHINGTON - The Food and Drug Administration finalized a plan on Wednesday that would ask drug companies to voluntarily limit the use of certain antibiotics in animal feed, citing long-held concerns that their overuse in livestock promotes the development of drug-resistant bacteria that can infect people.

Many antibiotics that are widely used to treat human illnesses, such as penicillin, are mixed with animal feed in part to promote rapid growth and weight gain in farm animals.  

No wonder the rivers and lakes are full of drugs.

The prevalence of antibiotics in livestock has been linked in several studies to the creation of drug-resistant “superbugs’’ that can spread to humans who eat, or even work with, the animals.  

So this is the excuse and cover they are going to use to cull the world population with bird or pig flu, huh?

The plan attempts to address a decades-long debate about a widely recognized public health hazard with global implications. As scientific evidence has mounted about the dangers of antibiotic resistance, the government has come under pressure to act swiftly.  

Keep that tone in mind for later, dear readers.

The voluntary path to regulation, supported by many in the drug industry, emerged as an efficient route to coping with the concerns, federal regulators said Wednesday.  

Yeah, it's what the industry wanted.

While some public health advocates hailed the move as a step in the right direction, others were less enthusiastic. Some critics argue that, given the drug industry’s track record, the government must place an outright ban on the use of antibiotics for growth promotion, as it proposed doing decades ago.

In 1977, the FDA proposed banning the use of penicillin and two forms of tetracycline for growth promotion. But after massive resistance from the industry and Congress, the agency never held hearings or took further action. The Natural Resources Defense Council and four other health and consumer advocacy groups sued the government last year to prompt action.

Last month, a federal district court in Manhattan ruled in favor of the plaintiffs and ordered the FDA to follow through on its initial proposal and start the proceedings that could lead to withdrawal of the drugs....  

Yeah, the TONE of the ARTICLE is the FDA is MAKING US SAFER, not they were ORDERED TO by the COURT after 35 YEARS!!!

The FDA must now grant the drugmakers an opportunity to appear at a hearing and prove that the antibiotics are safe, the court said. “If, at the hearing, the drug sponsors fail to show that the use of the drugs is safe, the [FDA] Commissioner must issue a withdrawal order,’’ Judge Theodore Katz wrote.

The government is considering whether to appeal that decision.

FDA officials said that with so many products approved for growth promotion, it would take decades of administrative proceedings and possibly litigation to withdraw each drug.

It already has, and now they are saying.... sigh.

They cite the agency’s effort to revoke approval of Baytril, an antibiotic used to treat chickens. The government succeeded in banning that use in 2004, but only after five years of efforts.

“This is the most expeditious way to get to the same result,’’ Michael Taylor, the FDA’s deputy commissioner for foods, said of the government’s plan, which was first proposed two years ago. “There is a real buy-in from the drug companies. They realize the time has come to make this shift.’’

Jeff Simmons, president of the drugmaker Elanco, said he supports the approach. He said his Indiana-based firm already plans to veer away from some of its antibiotics and adopt more natural alternatives. To that end, the company announced this year that it had acquired ChemGen in Gaithersburg, Md., which produces an enzyme that unlocks nutrients that are not readily available in feed.

The industry is now turning its attention to the details of how this plan will be put in place, devoting particular attention to the role veterinarians will play....  

See who is running our government?

--more--"  

FLASHBACK:

"Court orders FDA to ban antibiotics in feed" Washington Post, March 24, 2012

WASHINGTON - A federal court ordered the FDA on Thursday to follow through on a 35-year-old proposal that would have banned the use of certain antibiotics in animal feed because the agency was concerned that these drugs were overused in livestock and helped develop drug-resistant bacteria that can infect people.  

Yeah, the agency that cares so much about you and your health took 35 years and a court order.... sigh, cough, cough.

The concern is that some antibiotics given to treat illnesses in people are widely used on animals to promote disease prevention and weight gain, as well as compensate for crowded conditions on ranches and farms. 

Sorry, FDA works for corporate profits. 

The prevalence of those antibiotics in livestock has been linked in several studies to the creation of drug-resistant “superbugs’’ that can spread to humans who work with or eat the animals.  

Maybe true, but then again, that could just be a cover story put out by my paper before the globe-kickers decide to release some virus that will wipe-out a large chunk of an increasingly restless rabble. Or to simply stir the propaganda pot so more money will be poured into pharmaceuticals like what happened during the Swine Flu scare.    

In 1977, the Food and Drug Administration proposed banning the use of penicillin and two forms of tetracyline for growth promotion. But the proposal has been in limbo ever since. The agency never held hearings or took any further action, prompting the Natural Resources Defense Council and four other health and consumer advocacy groups to sue the government in May 2011.

A federal district court in Manhattan ruled in favor of the plaintiffs on Thursday, compelling the FDA to press forward with its initial plan to start proceedings that could lead to a withdrawal of the drugs.

Doesn't say it will lead to withdrawal.

The decision handed a major victory to consumer advocates.  

Had to wait 35 years and it ain't really a victory yet, but....

--more--"  

Time for a smoke, readers:

"Tobacco firms required to report chemicals" Associated Press, March 31, 2012

WASHINGTON - Tobacco companies will be required to report the levels of dangerous chemicals found in cigarettes, chew, and other products under the latest rules designed to tighten regulation of the tobacco industry.

The preliminary guidance issued Friday by the Food and Drug Administration marks the first time tobacco makers will be required to report quantities of 20 chemicals associated with cancer, lung disease, and other health problems. The FDA will require companies to display the information in a consumer-friendly format by next April.

Constituents or byproducts of tobacco products that are subject to the new rule include ammonia, carbon monoxide, and formaldehyde.

Regulators have identified more than 93 harmful or potentially harmful chemicals in tobacco products, though the agency is only focusing on 20 for the coming year. The agency will take comments on the guidance until June 4, before finalizing them.

A law enacted in 2009 gave the FDA authority to regulate aspects of tobacco marketing and manufacturing, though the agency cannot ban nicotine....

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At least they are looking out for the kids:

"FDA urges a lower dose of radiation when child undergoes medical scan" by Lauran Neergaard  |  associated press, May 10, 2012

WASHINGTON - When your child’s doctor orders a CT scan, X-ray, or similar test, there are two big questions: Is the scan really needed? And if so, will it deliver a child-sized or adult-sized dose of radiation?

That was the message from the Food and Drug Administration on Wednesday as it took steps to help protect children from getting unneeded radiation from these increasingly common tests.

The FDA is pushing manufacturers to design new scanners to minimize radiation exposure for the youngest, smallest patients. And it posted advice on the Internet urging parents to speak up when a doctor orders a scan - to ask if it’s the best option or if there’s a radiation-free alternative - and to track how many their child receives.

Too much radiation from medical testing is a growing concern, especially for children, because it may increase the risk of cancer later in life.

Specialists welcomed the FDA’s steps....

--more--"  

RelatedCT scans linked to children’s cancer

Also see: AmeriKa's Cancer-Causing Hospitals 

Avoid them and the airports whenever possible.

"Lawsuit says FDA monitored e-mails; Agency workers filed complaints" by Nedra Pickler  |  Associated Press, January 31, 2012

WASHINGTON - Current and former Food and Drug Administration officials say in a lawsuit that the agency secretly monitored their private e-mail after they raised concerns that approved medical devices might risk public safety.

The doctors and scientists who researched the products approached members of Congress and the incoming Obama administration to express alarm that the devices were approved over their objections.

Their lawsuit contends that the agency monitored e-mail sent from their personal Gmail and Yahoo accounts from work computers over two years. It says those e-mails included messages to congressional staff and drafts of whistle-blower complaints.

The staffers say they were legally protected whistle-blowers and the monitoring violated their constitutional rights to free speech and against illegal search and seizure, even though a warning on FDA computers said they had no expectation to privacy. The defendants say they were admonished or lost their contracts with the FDA in retaliation.

The FDA said yesterday it would not comment on ongoing litigation....

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I'm ready to throw up. 

UPDATES:

FDA Protects Big Pharma While Telling Americans "F*** You!"

FDA Doesn't Care About Cancer

FDA Approval to Immunize Drug Companies From Lawsuits