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FDA sets generic drug user fee rates for 2013

BY DSN STAFF

SILVER SPRING, Md. — The Food and Drug Administration has set user fee rates for generic drug companies, the agency said Jan. 27.

The FDA announced that it had published a notice in the Federal Register for companies that make finished dosage forms, meaning drugs in their final form, and active pharmaceutical ingredients, meaning the main ingredients of the drugs.

The fees for domestic factories making final dosage forms and active pharmaceutical ingredients are $175,389 and $26,458, respectively. For foreign factories, the fees are respectively $190,389 and $41,458.

The agency said that under the Generic Drug User Fee Amendments to the Prescription Drug User Fee Act, the fee for a factory outside the United States should be $15,000 to $30,000 higher than the fee for a domestic factory.

The FDA said it calculated the fee using data submitted by generic drug facilities through the self-identification process mandated under GDUFA.

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Awareness, use of e-cigarettes increasing rapidly, CDC study finds

BY Alaric DeArment

ATLANTA — The number of adult smokers who had used electronic cigarettes more than doubled in the space of a year, according to a new study by the Centers for Disease Control and Prevention.

The study found that in 2011, 21% of adults who smoke traditional cigarettes had used the electronic ones, up from 10% in 2010. During the same period, the number of adults who had used e-cigarettes increased among both sexes, non-Hispanic whites, people aged 45-54, people in the South and current and former smokers, though use of e-cigarettes was significantly higher among current smokers than among former and non-smokers. Meanwhile, awareness of e-cigarettes grew from 4-in-10 adults in 2010 to 6-in-10 in 2011.

"E-cigarette use is growing rapidly," CDC director Tom Frieden said. "There is still a lot we don’t know about these products, including whether they will decrease or increase use of traditional cigarettes."

The CDC said that though e-cigarettes appeared to have "far fewer" of the toxins than the smoke of traditional cigarettes, their long-term health effects would have to be studied, and research would be needed to find out marketing of them could affect initiation and use of traditional cigarettes.

The cigarettes — technically known as electronic nicotine delivery systems, or ENDS — work by atomizing liquid that contains nicotine and flavors into a vapor that users can inhale like traditional smoke, though they are designed to be odorless. In recent years, they have been touted as a healthier alternative to cigarettes, and surveys have indicated wide support for this view among consumers. But in addition to the CDC, health agencies like the World Health Organization have warned that their safety has not been demonstrated scientifically, and there could be risks that have not yet become clear due to the devices’ relative infancy. Regulators in countries like the United Kingdom have cracked down on ads that claim e-cigarettes are not harmful, while Israel’s Health Ministry on Thursday recommended subjecting them to the same regulations it imposes on traditional tobacco products or banning them altogether, the Israeli newspaper Haaretz reported.

"If large numbers of smokers become users of both traditional cigarettes and e-cigarettes — rather than using e-cigarettes to quit cigarettes completely — the net public health effect could be quite negative," CDC Office on Smoking and Health Tim McAfee said.

 

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Nonprofit provides ‘food stamps’ for pets

BY Alaric DeArment

NEW YORK — While the Supplemental Nutritional Assistance Program helps to keep some 50 million low-income Americans from going hungry, it excludes pet food, forcing many to give up their nonhuman family members. But a new program aims to alleviate the problem.

The Pet Food Stamps Program is a nonprofit group in New York that has a partnership with online pet products retailer PetFlow.com, whereby beneficiaries can receive a monthly home delivery of supplies for free.

In the fourth quarter of this year, the organization also plans to offer free or heavily discounted veterinary care for all qualified program beneficiaries as part of the program.

The New York Times has reported that unemployment, home foreclosures, evictions and other financial hardships have caused a sharp rise in the number of cats and dogs being surrendered to animal shelters, and Pet Food Stamps noted that most such animals will be put to sleep.

 

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