A follow - up from previous note regarding Perscription Imports. Thank you.
...Last week, the United States Food and Drug Administration warned drug makers and suppliers in the United States “to be especially vigilant” in watching for diethylene glycol. The warning did not specifically mention China, and it said there was “no reason to believe” that glycerin in this country was tainted. Even so, the agency called for all glycerin shipments to be tested for diethylene glycol, and said it was “exploring how supplies of glycerin become contaminated.”...
The premise to safe food and medication requires an agency well funded and staffed.
Reducing the Cost of Prescription Drugs
...American consumers pay the highest prices in the world for prescription drugs. It is no wonder that Americans turn to Canada to buy more affordable prescription drugs. The Congressional Budget Office (CBO) confirmed what many Americans already know – the same brand name drugs cost 35–55 percent less in other countries than they do in the United States.
The Pharmaceutical Market Access and Drug Safety Act will allow American consumers, pharmacies and drug wholesalers to import FDA–approved prescription drugs at substantially lower prices available on the world market. The CBO estimates that this legislation will result in $50 billion in direct savings over the next decade, with $6.1 billion of that in savings to the federal government.
The legislation does more than just make drug importation legal — it makes it safe. The bill includes a range of safety features intended to guarantee that only safe, FDA–approved prescription drugs are imported.
The legislation has strong bipartisan support and has been endorsed by a number of consumer organizations including the AARP....
Either one has faith in government when well funded to provide the safest environment to live and raise families or one doesn't. That is a primary complaint from Neocons/Republicans. Somehow they believe they can take better care of themselves if everything was privatized. That's impossible. Any one entity and I don't care if it's the largest pharmaceutical manufacturer on the face of Earth, can provide the insight or clout that a populous needs to protect itself.
Prior to George Walker Bush and his Advisory Council the FDA did magnificent work. They had some of the toughest standards on Earth. People would complain their standards were too tough and caused a backlog of medications available in Europe and other parts of the world but not in the USA. People of the USA would complain at the extent and length that manufacturers need to go in order to approve a medication or food product for sale to consumers in the USA, so the 'Fast Track' system was developed especially with the advent of HIV/AIDS.
The FDA 'was' commanded by the people of the USA to protect them. They do and they do it well. They have resources available that more than likely include and should include intelligence gathering capacity. It's all part of a secure homeland. There just isn't the capacity of any one private entity to provide the combined efforts that can come from the USA Treasury. There isn't. No one manufacturer can dialogue openly with clout with any country. There just isn't that capacity. So, if the people of the USA want safe water, food and consumer products they have to believe in a certain amount of government, well staffed and funded to achieve that. It is why corruption in government needs tight ethics laws with vigilance over corruption. I don't believe I have to go here. I have to put long established principles on a blog to 'orient' people BACK to a reality that once existed. It's interesting to realize how demoralized the government of the USA has become under this Executive Branch.
The reason the FDA has become an issue for anyone in this country is because they are a direct threat to the Pharmaceutical industry and Bush/Cheney cronies. Vioxx whistleblower David Graham prompted the fastest suffle in history of federal authority.
By Rita Rubin, USA TODAY
Food and Drug Administration whistleblower David Graham said Wednesday that he expects as soon as next week to be forced from his job in the Office of Drug Safety.
Food and Drug Administration whistleblower David Graham said Wednesday that he expects as soon as next week to be forced from his job in the Office of Drug Safety.
"I'm going to be transferred, and I don't want to go," said Graham, who told a Senate committee on Nov. 18 that the FDA is "virtually defenseless" against another "terrible tragedy and a profound regulatory failure" like Vioxx, an arthritis drug pulled off the market over concerns that it increased the risk of heart attack, stroke or sudden cardiac death.
When David Graham came forward Bush put forward an advisory council to the FDA that was to thwart it's ability to allow any regulation of the pharmaceutical business. In response to that advisory council the FDA set up a monitoring of the members and their participation to come to understand any 'conflict of interest' of the advisory council to the best interest of the American people. According to this unbiased study, the Bush FDA Advisory Council is a failure.
Who Responded? Advisory Committee Member characteristics (click on)
Finally, we asked some questions to let us know something about the advisory committee members who responded to our survey. The results showed:
This was the first advisory committee meeting for 13% of respondents; 33% had participated in 2 to 5 meetings, 35% had participated in 6 to 10 meetings, and 20% had participated in more than 10 meetings
15% had been recused by the FDA from serving at a particular advisory committee meeting due to conflict of interest. Of those who had been recused, 71% had been recused once, 21% had been recused twice, and the remaining 8% more than twice.
11% had recused themselves from serving at a particular advisory committee meeting due to a conflict of interest. Among those who had recused themselves, 90% had only done it once.
The FDA had limited the participation of 11% of the respondents during a particular advisory committee meeting. For 75% of those whose participation had been limited, this occurred only one time; it had occurred twice for 25% of the respondents.
Finally, we asked some questions to let us know something about the advisory committee members who responded to our survey. The results showed:
This was the first advisory committee meeting for 13% of respondents; 33% had participated in 2 to 5 meetings, 35% had participated in 6 to 10 meetings, and 20% had participated in more than 10 meetings
15% had been recused by the FDA from serving at a particular advisory committee meeting due to conflict of interest. Of those who had been recused, 71% had been recused once, 21% had been recused twice, and the remaining 8% more than twice.
11% had recused themselves from serving at a particular advisory committee meeting due to a conflict of interest. Among those who had recused themselves, 90% had only done it once.
The FDA had limited the participation of 11% of the respondents during a particular advisory committee meeting. For 75% of those whose participation had been limited, this occurred only one time; it had occurred twice for 25% of the respondents.
The FDA when empowered rather than demoralized can protect the people of this nation. It's time to put back all the safeguards we need in the USA. This IS Homeland Security. Whatever prompted the people of the USA to put Bush back in office? Maybe is was primarily corruption that could account for the mess. Go figure. Either you fund the protections of your own homeland or you fund the war.
The U.S. Food and Drug Administration (FDA) is warning pharmaceutical manufacturers, suppliers, drug repackers, and health professionals who compound medications to be especially vigilant in assuring that glycerin, a sweetener commonly used worldwide in liquid over-the-counter and prescription drug products, is not contaminated with diethylene glycol (DEG). DEG is a known poison used in antifreeze and as a solvent. Today, the agency is issuing guidance to industry recommending methods of testing glycerin and other controls to identify any contamination with DEG before use in the manufacture or preparation of pharmaceutical products.
The USA needs to return to a sanity it used to enjoy before September 11, 2001 while adding it's need for a tight National Security directive and review of it's military preparedness. This country has been completely demoralized by the Bush/Cheney White House. Please get over it people.
