PHARMACY

Report: Sharfstein to leave FDA

BY Alaric DeArment

SILVER SPRING, Md. — Food and Drug Administration principal deputy commissioner Joshua Sharfstein will leave the agency to become head of the Maryland Department of Health and Mental Hygiene, according to published reports.

The Washington Post reported Wednesday that Sharfstein, the FDA’s top official after commissioner Margaret Hamburg, had received an invitation to head the state health department from Gov. Martin O’Malley.

Before assuming his position at the FDA, Sharfstein served as head of the Baltimore City Health Department.

It was in that capacity that Sharfstein filed a Citizen’s Petition to restrict the recommendation of pediatric cough-cold medicines to children older than age 6 years. More recently, Sharfstein stood alongside Council for Responsible Nutrition president and CEO Steve Mister and other supplement industry representatives in announcing a crack-down on those Internet companies distributing adulterated pharmaceutical products marketed as dietary supplements.

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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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