Category: Food and Drug Administration

Diet

New Anti-Obesity Drug Qnexa Receives FDA Advisory Panel Approval

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Although I have lost my weight through the long drawn out process of diet and exercise, a drug, Qnexa, is showing some promise.

The second time’s a charm for Vivus’s experimental obesity drug Qnexa, at least when it comes to FDA advisory panel votes.

As the WSJ reports, one of the agency’s advisory panels today backed approval of the drug by a decisive 20-2 vote. The FDA — which often but not always follows the advice of its outside panels — is due to make its decision by April 17.

If the drug is approved, it would be the first new prescription weight-loss drug in over a decade. Qnexa combines low doses of two existing drugs: phentermine, which cuts appetite, and topiramate, now used to combat seizures and migraines.

Back in July 2010, FDA advisors voted against approving Qnexa by a margin of 10-6. The FDA itself nixed the drug later in the year, requesting more safety information.

Vivus submitted additional clinical data to the FDA in an attempt to allay its concerns. It’s not clear whether that will be enough to satisfy the agency, though. In briefing documents released ahead of today’s meeting, the FDA raised concerns about possible effects on the heart and about birth defects.

But it also noted that Qnexa produced “significant” weight loss in the first year of treatment, with some regain in the second year.

So, we will see if the FDA grants full approval.

This drug may provide the jump start that people need to start on the road to better health. It is probably not a panacea.

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Food and Drug Administration

Federal Judge Blocks Graphic Ads on Cigarette Packages

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The ads don’t bother me, but I suppose the law is clear about advocacy and the role of government.

A judge on Monday blocked a federal requirement that would have begun forcing tobacco companies next year to put graphic images including dead and diseased smokers on their cigarette packages.

U.S. District Judge Richard Leon ruled that it’s likely the cigarette makers will succeed in a lawsuit to block the requirement. He stopped the requirement until the lawsuit is resolved, which could take years.

Leon found the nine graphic images approved by the Food and Drug Administration in June go beyond conveying the facts about the health risks of smoking or go beyond that into advocacy – a critical distinction in a case over free speech.

More than likely there will be an appeal, but the images will not be placed on cigarette packages for the foreseeable future.

Matthew Myers, president of the Campaign for Tobacco-Free Kids, urged the Obama administration to appeal the ruling that he said “is wrong on the science and wrong on the law.” He said a delay would only serve the financial interests of tobacco companies that spend billions to downplay the health risks of smoking and glamorize tobacco use.

“Studies around the world and evidence presented to the FDA have repeatedly shown that large, graphic warnings, like those adopted by the FDA, are most effective at informing consumers about the health risks of smoking, discouraging children and other nonsmokers from starting to smoke, and motivating smokers to quit,” Myers said in a statement. “Because of that evidence, at least 43 other countries now require large, graphic cigarette warnings.”

Congress instructed the FDA to require the labels, following the lead of the Canadian regulations that require similarly graphic images on cigarette packs. The cigarette makers say their products have had Surgeon General warnings for more than 45 years, but that they never filed a legal challenge against them until these images were approved.

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Food and Drug Administration

Cigarette Makers Go to Federal Court Over FDA Graphic Warning Ads

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The cigarette manufacturers certainly don’t want an ad like the one depicted on the face of its product.

Cigarette makers clashed with regulators in U.S. federal court over new graphic labels and advertising that use pictures of rotting teeth and diseased lungs to warn consumers about the risks of smoking.

The tobacco industry asked Judge Richard Leon on Wednesday for a temporary injunction to block the U.S. Food and Drug Administration’s requirement for the labels, pending a final decision on whether the labels are constitutional.

The Obama administration argued, however, that the companies would not suffer irreparable harm without a preliminary injunction.

The labels are part of a 2009 law passed by Congress that requires color warnings on cigarette packages and on printed advertising, which already carry text warnings from the U.S. Surgeon General.

The industry says the new graphic warnings, due to go into effect by September 2012, force them to “engage in anti-smoking advocacy” on the government’s behalf.

“Never before has the government required the maker of a lawful product to tell consumers not to buy it,” said Noel Francisco, a lawyer arguing on behalf of R.J. Reynolds Tobacco Co.

“The government can tell people how to live,” said Floyd Abrams, a prominent First Amendment specialist also representing the tobacco industry. “But they can’t force people who sell tobacco to be their mouthpieces.”

The cigarette manufacturers have a good argument except their products cause death and why should the Food and Drug Administration be limited to text warning messages only. The government will win this lawsuit – eventually on appeal.

More than 221,000 Americans are expected to be diagnosed with lung cancer in 2011, according to the American Cancer Society. Tobacco is expected to kill nearly 6 million people worldwide in 2011, including 600,000 nonsmokers, the World Health Organization said in May.

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