Industry will miss Sharfstein's open, fair approach

The departure of Joshua Sharfstein, MD, from his position as deputy commissioner at the U.S. Food and Drug Administration (FDA) was met by expressions of both regret and admiration within the natural products industry.

The departure of Joshua Sharfstein, MD, from his position as deputy commissioner at the U.S. Food and Drug Administration (FDA) was met by expressions of both regret and admiration — regret that industry has lost a regulatory partner who was thoughtful and open, and admiration for the job he did in his brief time in office.

On Jan. 5, Maryland's Democratic Gov. Martin O'Malley announced that Sharfstein had accepted the job as the top public health official for the state of Maryland.

"He's been a great guy to work with. This is a man who absolutely understands what is meant by transparency in government," said Michael McGuffin, president of the American Herbal Products Association. "He will be missed. He made a difference in terms of access, in terms of inclusion."

"I'm personally disappointed to hear the news," added Loren Israelsen, executive director of the United Natural Products Alliance. "He had become a very constructive partner as a regulator."

The fact that Sharfstein has a reputation for being "very enforcement-minded" gave many in the dietary supplement industry "some pause when he came into the job," said Steve Mister, president and CEO of the Council for Responsible Nutrition. As Mister noted, Sharfstein served on the staff of Rep. Henry Waxman (D-California), who is known as no friend to the supplement industry. "I think he was eminently fair with the industry," Mister said. "He tried to make the agency more transparent. And in fact the industry needs more regulation."

Balancing access against risk

Although he did try to bring more enforcement to the dietary supplement industry, Sharfstein's efforts actually earned him more friends than enemies. "He he did it in a fairly objective way, and overall the industry benefits from that," Mister said. "It's a loss to the industry that he's leaving the agency."

During a hearing before the Senate Select Committee on Aging, Sharfstein broke new ground, McGuffin said. "When he testified before that Senate committee back in May, what he said was the way he thinks about DSHEA (the Dietary Supplement Health and Education Act) is that it balances access against risk, and that there's a very clear feeling in the law by Congress and the public that they want access to supplements that are important to people. That's never been clearly stated before. He acknowledged the Congressional intent and the agency's understanding that access is a factor," McGuffin said.

Industry sources lauded Sharfstein's careful preparation and thoughtful approach.

"He would come into every meeting absolutely prepared and with exactly the right staff," McGuffin said.

"I always felt that he was going to listen to our side and he was going to evaluate the information in front of him. There was no guarantee that he would agree with us. But he would give us the chance to make our case," Mister said.

Sharfstein spoke at CRN conferences and cooperated with industry in trying to remove tainted weight loss and erectile dysfunction products from the shelves and in trying to keep them from entering the market.

Israelsen said that Sharfstein's vigorous pursuit of the purveyors of tainted products was a high point of his tenure. "We knew that in him we had a committed leader," Israelsen said.

Both McGuffin and Mister are optimistic that the open, cooperative atmosphere that Sharfstein promoted while at FDA will outlive his tenure. How his shoes will be filled is another matter, as Sharfstein, who was acting commissioner for some months before current FDA commissioner Margaret Hamburg's appointment was confirmed, had an unusual amount of authority for a deputy commissioner.

McGuffin said that he had heard of no friction between Sharfstein and Hamburg. Rather, he thought that Sharfstein's decision to leave revolved around a great career move and a return to the public health sector.

"It's a really great job at a really important moment in time, and with terrific leadership in the state," Sharfstein told the Washington Post. "It was impossible to turn it down."

Sharfstein, a pediatrician by training, lives in Baltimore and before his stint at FDA was that city's top health official when O'Malley was mayor.

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