PHARMACY

FDA to require ‘substantially equivalent’ reviews of new tobacco products

BY Alaric DeArment

SILVER SPRING, Md. — Certain tobacco products introduced to the market or changed after Feb. 15, 2007, are subject to enhanced scrutiny by the Food and Drug Administration, the agency said Wednesday.

The FDA said it would require the companies making the products — ranging from roll-your-own tobacco to smokeless tobacco products — to prove they are “substantially equivalent” to those on the market on or before that date in order to keep them on the market — meaning they must be the same in terms of ingredients, design, composition, heating source and other characteristics. The new policy was adopted under the FDA’s authority to regulate tobacco products, mandated by the Family Smoking Prevention and Tobacco Control Act of 2009.

“This specific part of the law is meant to ensure that new tobacco products are evaluated by the FDA before they are cleared to enter the marketplace,” FDA Center for Tobacco Products director Lawrence Deyton said. “The law requires [the] FDA to carefully examine the impact those products may have on the public health.”

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The Trump stump

BY Jim Frederick

NEW YORK — In a slew of interviews in recent months with ABC News, Fox News, CNN and even the BBC, Donald Trump has made no secret of the fact that he’s seriously considering a presidential bid in 2012.


In an interview with ABC News correspondent George Stephanopoulos, Trump described himself as a Republican, and said that if he decided to run, it would be as a Republican. He added, “I’m going to make a decision probably by June.”


This isn’t the first time for Trump. He launched an exploratory committee in 1999 for a possible presidential bid as an independent candidate in 2000, and was mentioned as a possible running mate for George H.W. Bush in 1988. But he said his interest now is rooted in his alarm over the economy and the diminishment of America’s status in the world. “I’m looking at this country and what’s happened in terms of respect,” Trump told Stephanopoulos. Chinese business counterparts, he said, “laugh at us. They’re making the products we used to make in this country.” 


Thus, Trump said he’d push for a more assertive stance with China, which he declared is gaining the upper hand in manufacturing and job creation. “The problem is our jobs have left this country,” Trump told Fox News host Greta Van Susteren. “Between China and other places, we just don’t make product anymore. … We’re losing our jobs to other countries, and you’re not going to solve unemployment unless something very, very stringent is done,” Trump said.


Trump’s solution: “I would tax Chinese products. People say, ‘That’s not free trade.’ We don’t have free trade now. We have a country … that is ripping us [off]” by manipulating its currency to make Chinese goods cheaper for American companies and consumers to buy than U.S. goods, he asserted.


An informal poll of Internet users who have visited ShouldTrumpRun.com found support for the idea. Of the nearly 30,000 people who have responded to the question, “Should Donald Trump enter the 2012 presidential race?” two-thirds (67%) have responded in the affirmative. An almost equal number (66%) of those who responded to the survey also indicated they would vote for him.


However, a poll on DrugStoreNews.com told an opposite story, with 75% of the 387 online users who voted saying a Trump presidency would be bad for retail pharmacy.

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Kinray’s Stewart Rahr has a vision for America… Is it good for your business?

BY Jim Frederick

WHITESTONE, N.Y. — Business mogul, real-estate developer on a colossal scale with an ego to match, reality TV star, highest of the high-profile billionaires. Could Donald Trump’s next big role be president of the United States?


More importantly, would Trump the president be good for the country and, more specifically, for retail and wholesale pharmacy?


Stewart Rahr, fresh from the sale of the drug distribution business that propelled him into Trump’s stratospheric income bracket, clearly thinks so. Rahr, who owned and led Whitestone, N.Y.-based Kinray until its sale last fall to Cardinal Health, is putting his considerable energy and some of his own money into a determined campaign to convince Trump, his pal and occasional golfing partner, to run for the Republican presidential nomination in 2012 — and to deny President Obama a second term.


“He’d be an amazing president, as I see it, because he possesses the attributes the country needs as a president,” Rahr enthused in a mid-December interview with Drug Store News. “He’s intelligent and a tremendous negotiator. He’s a leader in every sense of the word, and he loves America.”


Rahr speaks with the sunny optimism and passion of a true convert, and the restless energy of the self-made billionaire, philanthropist and social dynamo he has become in the past three decades.


In an office whose walls are covered with photos of Hollywood celebrities and sports stars he calls friends, behind a desk covered with his trademark yellow sunglasses, Rahr, now approaching his mid-60s, still is on constant simmer.


Lately, the self-described “King of all Fun” is focused on what he sees as a high calling: the effort to put Trump into national office. “I’m devoting a lot of time trying to convince Donald that he’d make a good president,” Rahr told DSN.


Among other actions, Rahr has lent his support to a new website, ShouldTrumpRun.com, and issued a statement to solicit input and support for a presidential bid by his friend. In that solicitation, he called Trump “a natural born leader with outstanding ability to inspire others and to accomplish impossible tasks.” He also cited a poll from NewsMax.com 
to assert that Trump could win in a head-to-head contest versus President Obama. “Please join me in trying to convince Donald to consider running for this high office,” Rahr told supporters. “This is as serious as I get,” he added.


Rahr described Trump as “a social moderate” who would aggressively promote America’s return to undisputed global economic leadership. “Donald doesn’t like being second to China or to India,” he asserted. “He’s a visionary, and he thinks forward. He’d love to bring jobs back to America, and ensure that every American has a job. We need a businessperson … [who] can surround himself with the brightest intellectual minds and get things done.”


What would a Trump presidency mean for retail and wholesale pharmacy? Rahr asserted the billionaire “would be a great champion for our industry. … He doesn’t like the Obama healthcare plan,” the executive said. “He thinks there’s too many holes in it, it doesn’t take care of everyone and it’s too expensive. As for the pharmaceutical industry, as long as the product is made in America, he’d support it because that creates revenues and employs Americans,” Rahr said. “He’ll be a friend of this industry, as long as it would be made or distributed here in the United States and not elsewhere.”


A Trump presidency also would benefit from its ties to the former Kinray leader, Rahr said. “With [my background 
in] the pharmaceutical industry, certainly we’d have an ear to explain the problems we have as manufacturers and as distributors, in health care and pharmacies especially. … I am who I am today because of the pharmaceutical business.”


Rahr predicted his friend likely will 
make a decision over the next few months — and may begin campaigning in earnest by May or June. “I think it’s going to happen,” he confidently stated.

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H.BURKE says:
Jan-07-2011 06:10 pm

I had the honor of working with Kinray employee's in the distribution a new generic Rx oral rinse. I found the Kinray employee's to be a very determined, professional and a result-oriented team under Stewart Rahr's leadership. In fact, I was also honored to witness and hear the story on how Stewart Rahr personally saved the famous 9-11 Ground Zero photograph autographed by the three fireman raising the American Flag by outbidding parties outside the United States. Stewart Rahr has a Servant Leadership reputation. He's demonstrated concerned about the welfare his employee's and our industry. I believe his support of Donald Trump is an indication of his desire to improve the quality and strength of U.S. leadership at home and around the world. I support Stewart Rahr's goal of getting Donald Trump to run for President. We have too many lawyers in Washington D.C.---we need experienced business executives to put America back on course. Hal Burke National Accounts Manager Xttrium Laboratories 773-268-5800 (Ext. 160) halburke@xttrium.com

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