Company penalized for misleading marketing of impotence drug
PROVIDENCE, R.I. --A company that marketed an impotence drug called "Penetrex" or "Penetrin" has been penalized roughly $1 million after admitting to misbranding the drug and selling it without the approval of federal regulators.
Federal prosecutors say Florida-based White Broadman Inc. intentionally misled the public by selling unapproved over-the-counter erectile dysfunction drugs in a direct mail marketing campaign from 2001 to 2004.
They say the company misbranded the drug by calling it a dietary supplement.
U.S. District Judge Mary Lisi on Friday fined White Broadman more than $794,000, and the company and president James Mienik also forfeited $205,000.
Mienik and part-owner Paul Romano pleaded guilty last year to one federal misdemeanor count of introducing a misbranded substance in interstate commerce without FDA approval, said company attorney Kevin Napper of Tampa, Fla.
"There was no health risk to the public," Napper said. "There is a difference of opinion over the efficacy of the product."
The company listed an East Greenwich address, but had no offices or operations in Rhode Island. Customers' orders mailed to the East Greenwich address were forwarded to the company's offices in Florida.
In addition, prosecutors say the company listed a director of research and development who did not actually exist and fabricated reports of customer experiences and clinical tests in order to sell the drugs. The company's mass mailings included a photograph of buildings that it said were its urological science laboratories, but were actually buildings at the University of Florida. 