|The clinic is engaging in interstate commerce and is therefore subject to FDA regulation because any part of the machine or procedure that originates outside Colorado becomes interstate commerce once it enters the state. Moreover, interstate commerce is substantially affected because individuals traveling to Colorado to have the Regenexx procedure would “depress the market for out-of-state drugs that are approved by FDA.”|
|WASHINGTON—The Food and Drug Administration's No. 2 official is leaving the agency after a busy 21-month tenure that included clashes with drug and device makers over tougher regulation.|
Deputy Commissioner Joshua Sharfstein, 41 years old, is taking the top public-health job for the state of Maryland, a spokesman for Maryland's governor said, with an announcement scheduled for Wednesday.
The FDA is losing a regulator who has pushed for a greater emphasis on drug safety. For example, he helped bring about an unusual review of the diabetes drug Avandia last year that resulted in much tighter curbs on its use.
The departure could have an effect on the FDA's coming release of new guidelines on medical-device approvals. Any significant restrictions will likely cause a backlash in the device industry, which has allies among Republican House leaders.
The new chairman of the House oversight committee, Darrell Issa (R., Calif.), says he wants to take a closer look at FDA issues, having already chastised Dr. Sharfstein in a hearing last September over delays in the withdrawal of defective lots of the pain pill Motrin in 2009. Some House lawmakers also want to investigate the FDA's move in December to withdraw approval of the drug Avastin to treat breast cancer.
(Note: So we know that Darrell Issa sucks up to pharma)
Dr. Sharfstein and FDA Commissioner Margaret "Peggy" Hamburg declined to discuss his departure.
After arriving in late March 2009, when he briefly served as acting commissioner, Dr. Sharfstein took on the FDA's device division, where a device for knee surgery had been cleared in late 2008 over the repeated objections of a half-dozen FDA scientists and managers.
His review, prompted by articles in The Wall Street Journal in 2009, led to the FDA's announcement that it planned to revoke the approval of the knee device. The FDA also said it would likely toughen guidelines for an abbreviated device-approval process that is popular with the industry.
Under Dr. Hamburg and Dr. Sharfstein, the agency is issuing more warning letters over manufacturing and marketing violations, while largely stopping the practice of letting companies spend months negotiating the content of these letters, according to industry lobbyists in Washington.
Another change that has alarmed the industry is the focus by the FDA on punishing individual executives and corporate lawyers, not just companies, over alleged wrongdoing. In November, a former lawyer for GlaxoSmithKline PLC was indicted in a Justice Department and FDA investigation into Glaxo marketing practices. The company has said it was cooperating with the government. The lawyer has pleaded not guilty.
Dr. Sharfstein's review of Avandia, the troubled diabetes drug, opened a rift with the longtime head of the FDA's drug division, Janet Woodcock, who had defended the drug as a useful option for patients. The sides came to a truce in September, with restrictions that all but ended new prescriptions of the drug while allowing patients still on it to continue to use it. (continued)
|By Emily P. Walker, Washington Correspondent, MedPage Today|
WASHINGTON -- FDA Commissioner Margaret Hamburg, MD, addressed on Monday the "increasing drumbeat" of criticism suggesting that the agency is slowing innovation by requiring drug and device companies to wait excessively long periods for approval.
"You may be aware of increasing drumbeat of the FDA as a 'bureaucratic regulatory agency' impeding innovation of certain industries, the drug and device industries in particular ... potentially driving U.S. companies overseas," she told a small crowd at a discussion sponsored by the watchdog group Public Citizen.
Hamburg said she wanted to clear up some misconceptions, among them the notion that the FDA takes much longer to approve drugs and devices than Europe. In priority drug approval -- approval for new drugs that meet an unmet public health need -- the FDA is often the first regulatory body to award approval, she said.
In any case, speed is not the most important factor, she said.
"The number of new drugs, the speed of their delivery matters, but the most important foundation of all that we do and what really makes a difference ... and is the number one issue for the American people, is that they can have trust and confidence that the products we reviewed are in accordance with science and efficacy and that our agency has the commitment to that regulatory process that is unwavering," she said.
The FDA has come under criticism, especially from the device industry, for not being clear enough on what it expects from device makers from the get-go, for taking too much time from application to approval, and for having poorly trained device reviewers.
The head of the FDA's Center for Devices and Radiological Health (CDRH), Jeffery Shuren, MD, has said that device arm of the FDA is plagued by an "unacceptably high" turnover rate for reviewers.
When asked about the cause of the turnover at CDRH, Hamburg said that the FDA's drug division used to have the same problems, but things improved when the drug division began collecting user fees from pharmaceutical companies -- the FDA's drug division collects about 10 times more in user fees than the agency's device arm. Since then, the agency's drug reviewers haven't been "stretched a million ways" and the work environment got better, she said.
|What happened to change the desire of the heads at FDA from fighting the pharma/govt fascist alignment to basically joining it?|
Quote from: Satyagraha on September 23, 2010, 01:47:36 PM
We saw this coming when Obama put Michael Taylor in charge of the FDA:
You're Appointing Who? Please Obama, Say It's Not So!
The person who may be responsible for more food-related illness and death than anyone in history has just been made the US food safety czar. This is no joke.
Here's the back story.
When FDA scientists were asked to weigh in on what was to become the most radical and potentially dangerous change in our food supply -- the introduction of genetically modified (GM) foods -- secret documents now reveal that the experts were very concerned. Memo after memo described toxins, new diseases, nutritional deficiencies, and hard-to-detect allergens. They were adamant that the technology carried "serious health hazards," and required careful, long-term research, including human studies, before any genetically modified organisms (GMOs) could be safely released into the food supply.
But the biotech industry had rigged the game so that neither science nor scientists would stand in their way. They had placed their own man in charge of FDA policy and he wasn't going to be swayed by feeble arguments related to food safety. No, he was going to do what corporations had done for decades to get past these types of pesky concerns. He was going to lie.
Dangerous Food Safety Lies
When the FDA was constructing their GMO policy in 1991-2, their scientists were clear that gene-sliced foods were significantly different and could lead to "different risks" than conventional foods. But official policy declared the opposite, claiming that the FDA knew nothing of significant differences, and declared GMOs substantially equivalent.
This fiction became the rationale for allowing GM foods on the market without any required safety studies whatsoever! The determination of whether GM foods were safe to eat was placed entirely in the hands of the companies that made them -- companies like Monsanto, which told us that the PCBs, DDT, and Agent Orange were safe.
GMOs were rushed onto our plates in 1996. Over the next nine years, multiple chronic illnesses in the US nearly doubled -- from 7% to 13%. Allergy-related emergency room visits doubled between 1997 and 2002 while food allergies, especially among children, skyrocketed. We also witnessed a dramatic rise in asthma, autism, obesity, diabetes, digestive disorders, and certain cancers.
In January of this year, Dr. P. M. Bhargava, one of the world's top biologists, told me that after reviewing 600 scientific journals, he concluded that the GM foods in the US are largely responsible for the increase in many serious diseases.
In May, the American Academy of Environmental Medicine concluded that animal studies have demonstrated a causal relationship between GM foods and infertility, accelerated aging, dysfunctional insulin regulation, changes in major organs and the gastrointestinal system, and immune problems such as asthma, allergies, and inflammation
In July, a report by eight international experts determined that the flimsy and superficial evaluations of GMOs by both regulators and GM companies "systematically overlook the side effects" and significantly underestimate "the initial signs of diseases like cancer and diseases of the hormonal, immune, nervous and reproductive systems, among others."
The Fox Guarding the Chickens
If GMOs are indeed responsible for massive sickness and death, then the individual who oversaw the FDA policy that facilitated their introduction holds a uniquely infamous role in human history. That person is Michael Taylor. He had been Monsanto's attorney before becoming policy chief at the FDA. Soon after, he became Monsanto's vice president and chief lobbyist.
So Obama puts a couple of watchdogs in the FDA... followed by a Monsanto lobbyist at the top. Fits, doesn't it? Good creds for appointing sincere people like Sharfstein, and then make them ineffective by putting Monsanto in charge (essentially).
Dr. Burzynski is up against a multi-billion dollar industry that sits in control of the FDA: he won't get funded for his amazing cancer therapy treatment, he won't get a dime. That's got to come from people like us, who see what's happening to people, who understand that there is no 'financial incentive' for pharma/FDA (same thing) to approve of a non-toxic treatment like Burzynski's... when they can sell the toxic chemo and radiation treatments for big bucks. And, since cancer is big business - and keeping people sick fits into that, it's approved 100% by the elite eugenicists who sit over the pharma boys. This is how things are. We have to take care of ourselves.