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Fla. drug company owners plead guilty to selling unapproved pills

01:00 AM EST on Friday, November 16, 2007

By W. Zachary Malinowski

Journal Staff Writer

PROVIDENCE — The owners of a Florida-based pharmaceutical company pleaded guilty yesterday to federal charges that they sold more than $4 million worth of what had been billed as an erectile-dysfunction drug that had not been approved by federal regulators.

James Mienik, 37, and Paul Romano, 58, both of Florida, admitted to misdemeanor charges of introducing a drug that had been misbranded. They agreed to forfeit more than $794,000 to their company, White Broadman Inc., which will in turn surrender the money to the government.

Federal investigators also seized $205,000 from Mienik’s bank accounts. Tom Connell, spokesman for Robert Clark Corrente, U.S. Attorney for Rhode Island, said that Mienik has not contested the seizure of that money.

White Broadman, through its lawyer, Anthony Traini, of Providence, pleaded guilty to a felony charge of introducing through interstate commerce a new drug that had not been approved by the U.S. Food & Drug Administration.

Assistant U.S. Attorney Terrence Donnelly laid out White Broadman’s scheme yesterday during a plea hearing before Chief U.S. District Judge Mary M. Lisi. He said that in 2001 the firm began a “direct mass market campaign” of selling the erectile-dysfunction drug.

A White Broadman brochure identified R.T. Edwards as director of research and development and it provided a photograph of a brick tower that was billed as the firm’s urological laboratories in East Greenwich. The brochure also had quotes from customers talking about their “satisfied experiences.”

Donnelly told the court that Edwards did not exist and that the brick tower was actually a building on the campus of the University of Florida in Gainsville.

The firm listed an address of 5600 Post Rd., Suite 114, in East Greenwich.

“In reality, there was no suite,” said Donnelly, adding that the quotes from customers were fictitious. He said federal investigators found no connection between Mienik, Romano and Rhode Island.

Donnelly said that White Broadman sold thousands of bottles of the pills, called Penetrix, and later, Penetrin, for $59.99 and $79.99 over a three-year span ending in February 2004. Asked whether the medicine actually worked, he said, “I’m not prepared to comment on that.”

Donnelly said the firm did reimburse some customers who were not satisfied with the drug.

Judge Lisi released Mienik and Romano on unsecured bond and ordered them to return for sentencing on Feb. 29.

bmalinow@projo.com

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