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November 15, 2007

Firm pleads guilty to fraudulent sales of ED drug

PROVIDENCE -- The owners of a Florida-based pharmaceutical company pleaded guilty to federal charges today of selling more than $4 million of an erectile dysfunction drug that had never been approved by the federal regulators.

James Mienik, 37, chief executive officer of White Broadman Inc., and Paul Romano, half owner of the company, admitted to misdemeanor charges that they introduced a drug that had been misbranded.

They agreed to turn over more than $794,000 to White Broadman, who, in turn, will surrender the money to the government. The government also has seized $205,000 that Meinik had in bank accounts.

White Broadman, through its lawyer, Anthony Traini, of Providence, pleaded guilty to a felony charge of introducing a new drug through interstate commerce without approval by the Food & Drug Administration.

Terrence Donnelly, an assistant U.S. attorney, told the court that the firm sold Penetrix, which later became Penetrin, to thousands of customers nationwide through direct mail. Bottles of the drug sold for $59.95 and $79.95 from 2001 through February 2004.

The U.S. Postal Service launched an investigation after it received complaints from customers.

Asked whether the erectile dysfunction drug worked, Donnelly said, ``I’m not prepared to comment on that.’’

The direct mail order brochures included a corporate address on Post Road in East Greenwich. Donnelly said that the company had a post office box, but no offices in Rhode Island.

-- Journal staff writer W. Zachary Malinowski

Posted by Mike McKinney  at 4:03 PM | Permalink

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