« Citizens Financial Group names new CEO | Today | Update: URI students return to class after bomb threat »

March 3, 2008

Company selling unapproved drug gets stiff fine

PROVIDENCE -- A federal judge has imposed $1 million in penalties on a Florida-based pharmaceutical company and its president, who pleaded guilty in November to charges of carrying out a misleading marketing campaign for what had been billed as an erectile-dysfunction drug but was unapproved by federal regulators.

White Broadman, Inc., was fined $794,334 for misleading marketing of the unapproved drug and the company and president James Mienik forfeited $205,000, U.S. Attorney Robert Clark Corrente announced today. U.S. District Court Judge Mary M. Lisi imposed the penalties on Feb. 29.

Mienik and Paul Romano, a part owner of the company, admitted to misdemeanor charges of introducing a drug that had been misbranded. White Broadman, through lawyer Anthony Traini of Providence, pleaded guilty to a felony of introducing through interstate commerce a new drug that did not have U.S. Food and Drug Administration approval.

Prosecutor Terrence P. Donnelly said at the plea hearing that the government could prove that from 2001 until 2004 the company engaged in a direct mail marketing campaign for an over-the-counter drug called variously “Penetrex” and “Penetrin.” White Broadman sent out mass mailings promoting the drug.

The solicitations gave an East Greenwich address, "but that was merely a mail drop, and the company did not have any facilities or operations in Rhode Island," the U.S. Attorney's office news release said.

The owners sold more than $4 million worth of what was said to be ab erectile dysfunction drug.

The defendants had orders that customers mailed to the East Greenwich address forwarded to Florida company offices.

The federal prosecution said the solicitation misled in that:

* R.T. Edwards, identified as White Broadman’s “director of research and development,” doesn't exist.

* The solicitation included a photograph, which purported to be of White Broadman’s urological science laboratories in East Greenwich, which was in fact a picture of a University of Florida campus building in Gainesville.

* The solicitation gave fictitious customers’ experiences, contained fabricated “attending physician’s diagnosis & treatment recommendations,” and claimed clinical tests that were never done.

-- projo.com staff writer Michael P. McKinney, with Journal archival reports

Posted by Mike McKinney  at 3:30 PM | Permalink

Comments

Steve | March 3, 2008 5:01 PM link

Post a comment

Please be civil. Vicious comments, personal attacks and profanity won't be published. Name and email are required; email address will not publish.

Name:

Email Address:

URL:
Remember Me? YesNo

Comments: (you may use HTML tags for style)