Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts

Tuesday, November 29, 2011

FDA TO REGULATE CIGARS????

FROM: THE DAILY CALLER

Cigar smokers are mad as hell, and they aren’t going to take it anymore. Faced with an unprecedented assault on their guilty pleasure from President Barack Obama’s Food and Drug Administration, aficionados and industry insiders told The Daily Caller that they’re picking up their torch lighters and revolting.

Usually divided by their preferences for mild, medium and full-bodied smokes, they’re uniting against regulations that threaten to make cigars prohibitively expensive, shut down scores of small cigar shops, jeopardize tens of thousands of jobs and erase the traditionally bright line between Camels and Cohibas.
Cigar lovers are also recruiting members of Congress to defend what public health activists and anti-cancer crusaders see as little more than gentrified cigarettes smoked by economic one-percenters.

“Only a couple weeks remain,” one apocalyptic online pitch warns, “to stop the FDA from ruining cigars.” If that seems like a stretch, don’t bother telling Famous Smoke Shop. The e-tailer has sent 1.7 million emails to customers on its mailing lists, asking them to encourage their representatives in Congress to co-sponsor legislation designed to tie the FDA’s hands.

Cigar industry representatives told TheDC that efforts like this have already generated more than 113,000 messages to Congress.

It’s no surprise, then, that 125 House members and four senators are on board. They include 26 Democrats, along with six of Congress’ 20 physicians and two of its seven nurses — all strange bedfellows for a pro-tobacco law in the making.

Sen. Mary Landrieu, a Louisiana Democrat, announced Wednesday that she will join them. Landrieu chairs the Senate Committee on Small Business & Entrepreneurship, a crucial position from which to influence an issue that affects mostly mom-and-pop retailers.

Cutting an Exception
The Traditional Cigar Manufacturing and Small Business Jobs Preservation Act of 2011 arrived in the House in April and the Senate in August. Much of the domestic cigar supply enters the United States in the Sunshine State, and two Florida legislators — Republican Rep. Bill Posey and Democratic Sen. Bill Nelson — are leading the charge.


The bill’s focus is to carve out an exception for premium cigars in the Family Smoking Prevention and Tobacco Control Act, signed into law by President Obama in 2009.

The Tobacco Control Act (TCA) gave the FDA new authority to regulate tobacco, and the agency has most famously wielded that power by requiring garish photographic warnings this year on cigarette packs. But the law, an FDA spokesperson told The Daily Caller in an email, “also permits FDA to deem other ‘tobacco products’ subject to the TCA’s general controls by regulation.”

The FDA spokesperson explained that a “proposed rule deeming cigars to be subject to FDA’s jurisdiction” could be “finalized” after a public-comment period expires, giving the agency the authority to regulate “any product that meets the definition of a ‘tobacco product’ under the TCA, including cigars, little cigars, and certain novel nicotine containing products (such as certain electronic cigarettes).”

The FDA seems to be taking its longer leash seriously. On three occasions since December 2010, the agency has already put the cigar industry on notice that it intends to propose a rule to “deem cigars subject to the Tobacco Control Act.”

The “non-face-to-face sale and distribution of tobacco products” is likely to be the first battleground. A Sept. 9 FDA announcement called for public comment on whether Internet and mail-order sales of tobacco — all varieties of tobacco — serve as a giant loophole for consumers under 18 who can’t legally buy it at retail counters.

A federal regulation banning long-distance sales of cigars could be finalized soon after December 8, the date when the FDA is scheduled to stop accepting public comments on that particular objective.

Smoke-Free Kids
Rep. Posey isn’t buying the argument that teens are spending their money to buy Kristoffs , Montecristos and Perdomos through the mail.

“The intent of the Tobacco Control Act was to regulate products that are marketed to children,” Posey and Florida Democratic Rep. Kathy Castor wrote in a “Dear Colleague” letter circulated to members of Congress on March 31. And “traditional large and premium cigars are not a product used by youth.”

“When was the last time you saw 18-year-olds plunking down big bucks for Cohibas?” a customer at JR Cigar in downtown Washington, D.C., asked TheDC on Tuesday. “They wouldn’t appreciate it anyway.”

Cigar Rights of America executive director Glynn Loope told TheDC that “premium cigars’ price point, and the very marketing of cigars, are not directed toward youth. We feel very strongly that no one underage should have any type of access to tobacco products.”

Loope’s organization is less than three years old, but already represents retailers in 49 states with a combined customer base of more than 3 million cigar smokers.

FDA Commissioner Margaret Hamburg has received a steady stream of friendly but pointed letters from members of Congress — at least 20 so far — all of which draw clear distinctions between high-end cigars and youth smoking concerns.

Sen. Nelson was among the first, writing to Hamburg in August 2010. “Premium cigars are generally more expensive than mass produced tobacco products and are sold almost exclusively at specialty tobacco shops,” Nelson wrote, “making them significantly less likely to be used by adolescents. … The concern about widespread cigarette dependence and youth access simply does not apply to a discussion about premium cigars, which is why Congress focused on cigarettes rather than premium cigars in the Tobacco [Control] Act.”

Public Health Push-back
Lined up in opposition to the stogie revolution is a coalition of more than 40 medical, cancer prevention and public health groups. On Sept. 7 they wrote to co-sponsors of Posey’s bill, asking them to remove their names from the legislation. To date, no one has.

“While the health risks of cigar smoking are not the same as cigarette smoking,” the groups wrote, “cigar smoke is composed of the same toxic and carcinogenic constituents found in cigarette smoke.”

The most vocal opponents in Congress have been Democratic Senators Sherrod Brown of Ohio, Richard Blumenthal of Connecticut and Frank Lautenberg of New Jersey.

Sen. Lautenberg is a long-time advocate for cancer research funding. He established the Lautenberg Research Center at The Hebrew University of Jerusalem in memory of his father, who died of cancer at a young age.

The six members of Congress with MDs — Reps. Paul Broun of Georgia, Charles Boustany of Louisiana, Dan Benishek of Michigan, Scott DesJarlais and Scott Roe of Tennessee and Ron Paul of Texas — are bucking the medical establishment in co-sponsoring Posey’s H.R. 1639. Reps. Renee Ellmers of North Carolina and Diane Black of Tennessee, both with nursing degrees, are following suit.

None of the three physicians in the Senate — Republicans Tom Coburn of Oklahoma, John Barrasso of Wyoming, and Rand Paul of Kentucky — is a co-sponsor of S. 1461, the Senate’s version of Posey’s bill.
Sen. Landrieu, along with Reps. Benishek, Black, Boustany, Broun, DesJarlais and Roe did not respond to requests for comment about their reasons for co-sponsoring the bill.

A spokesperson for Rep. Paul, who is also a Republican candidate for president, emailed TheDC to say that while Rep. Paul does not smoke cigars himself, he believes “Americans have the right to use tobacco products without being subject to federal restrictions, regulations, or taxes.”

“The federal government has no constitutional authority to regulate any form of tobacco product,” Rep. Paul’s spokesperson added. “Youth smoking is a legitimate concern but discouraging young people from using tobacco products is the responsibility of local communities, schools, churches, and most importantly, parents — not the federal government.”

Rep. Ellmers, a former surgical intensive care nurse, said through a spokesperson that “tobacco use is an individual choice and legally protected.” She called H.R. 1639 “a technical correction on how cigars are classified,” and a small-business measure “that will save approximately 85,000 American jobs.”

Regardless, the National Cancer Institute is certain that cigars are a health risk worth avoiding. “Although cigar smokers have lower rates of lung cancer, coronary heart disease, and lung disease than cigarette smokers,” the agency says, “they have higher rates of these diseases than those who do not smoke cigars.”

Most cigar smokers, Loope told TheDC, already know this. He sees the FDA as “an activist federal agency” interfering with “adults making adult decisions.”

“Our opposition wants nothing short of tobacco prohibition,” Loope said. “And we’ve seen how the first attempt at vice prohibition worked.”



Determined to Regulate
A close reading of the FDA’s proposed rule shows that the agency is taking seriously its responsibility to make sure no one can buy tobacco without showing an ID — a scenario that the Internet makes practically impossible to guarantee.

The Alcohol and Tobacco Tax and Trade Bureau, a division of the U.S. Treasury Department, acknowledges that there is no federal law explicitly banning the sale of tobacco over the Internet. But Famous Smoke Shop is one of the biggest online cigar retailers, and it’s taking the FDA’s proposals seriously.

Posey’s new legislation “is the last hope against legislation that would spell the end of premium cigars as we know them,” Famous spokesman Heyward Tenney told TheDC in an email.

The public health coalition opposing the bill are mainly concerned with what they see as widespread teen use of “cigarillos” and “small cigars,” many of which “come in flavors and are among the most popular with youth,” according to their Sept. 7 letter.

Wednesday, December 22, 2010

Breast Cancer? The FDA BANS AVASTIN

With all the attention Breast Cancer Prevention gets you would think this decision as reported below would be unlikely. But I guess we should get used to rationing.

From Investors Business Daily: ObamaCare Rationing Begins

Medicine: The FDA has reversed its approval of a widely used cancer drug approved in Europe to treat breast cancer on the grounds it doesn't provide a "sufficient" benefit. Let the terminally ill and their doctors decide.

One of the blessings of blocking the omnibus spending bill was that it included $1 billion for the implementation of ObamaCare.

Yet the first effects are still being felt, the latest being the Food and Drug Administration's revoking of regulatory approval of Avastin to treat late-stage breast cancer.

The reason given by the FDA was that the drug does not provide "a sufficient benefit in slowing disease progression to outweigh the significant risk to patients." What risk? These women are dying.
The drug buys them precious time, and the only risk they face is from an FDA saying "pull the plug."
On the same day the FDA channeled Dr. Kevorkian, its European counterpart, the European Medicines Agency, issued a statement approving Avastin for metastatic breast cancer.

Benefits of the drug, it said, "continue to outweigh the risks, because the available data have overwhelmingly shown to prolong progression-free survival of breast cancer patients without a negative effect on the overall survival."

So what say you, FDA? An agency overseeing the cost-conscious, government-run health care systems in the European Union says Avastin does provide sufficient benefit at little risk to the patient.

The annual cost, however, is a staggering $88,000 annually, and under ObamaCare cost trumps medical care. A prime decision is whether extending your life is worth the cost.

Consider that every year some 17,500 American women are prescribed Avastin by their practicing oncologists to treat their condition and prolong their life. Last October, the U.S. National Comprehensive Cancer Network, a group of 21 leading cancer centers that issues evidence-based medical guidelines, reaffirmed Avastin's efficacy in certain cases.

Avastin, the marketing name for the drug bevacizumab, is the world's best-selling cancer drug. Used primarily to treat colon cancer, it was first approved by the FDA in 2008 for treating breast cancer after it was found that by cutting the blood flow to tumors it slowed the progression of the disease. In some cases it has been shown to extend life as long as 20 months.

In a joint letter to the FDA and key lawmakers, two organizations — Susan G. Komen for the Cure and the Ovarian Cancer National Alliance— urge that Avastin continue to be approved for metastatic breast cancer patients and warn of the message this "decision sends about drug development for women with advanced breast cancer."

Breast cancer is the second most common cause of cancer death among American women, with 40,000 fatalities last year. Komen says the decision to use Avastin should be made between a woman and her doctor after a thoughtful consideration of the benefits and risks. We agree.

Avastin is still available on an off-label basis since it is still approved for colon, lung, kidney and brain cancer. But insurers are reluctant to cover drugs that are not FDA-approved. Medicare never does and the Centers for Medicaid and Medicare Services are now headed by Dr. Donald Berwick, to whom we and others have referred as a one-man death panel.

"The decision is not whether or not we will ration care — the decision is whether we will ration with our eyes open," Berwick has said. For some that will mean the eyes closing forever.

Berwick has also opined: "We can make a sensible social decision and say, 'Well, at this point, to have access to a particular additional benefit (new drug or medical intervention) is so expensive that our taxpayers have better use for those funds.'"

Like what? Tattoo-removal programs or Formosan subterranean termite research? This is your government, and it's here to help.
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