Violation of Food and Drug Act

Four men have pleaded guilty to trying to sell a product not approved for younger children to Kansas physicians.

The four defendants, who were employees of Medicis Pharmaceutical Corp. of Scottsdale, Ariz., each pleaded guilty to one misdemeanor count of conspiracy to violate the Food, Drug and Cosmetic Act.

Pleading guilty were:
-Ralph Bohrer, 47, Scottsdale, Ariz., former general manager of pediatric products
-Steve Evans, 53, Scottsdale, Ariz., former director of Ascent field sales
-Rick Havens, 59, Scottsdale, Ariz. former executive vice president of Medicis sales and marketing
-Victor Lugo, 51, Lutz, Fla., former Loprox product manager

"The defendants had a name for what they were doing," said U.S. Attorney Eric Melgren. "They called it 'attacking the diaper dermatitis market.'"

Each of the four defendants was sentenced to:
-Three years probation
-A find of $5,000
-In lieu of restitution, a payment of $25,000 to the Crime Victims Fund
-A $25 special assessment

In their pleas, the defendants admitted:
-Loprox is a dermatological brand-name prescription drug used to treat certain skin conditions. It has been approved by the FDA to treat skin infections only in patients over the age of 10. It is not approved for treatment of younger children.
-During 2001 through 2004, the defendants marketed Loprox and Loprox TX to pediatricians as a drug to treat children under 10 for conditions including diaper rash. They trained sales reps to market the drug and instructed them to use a sales pitch emphasizing the "spreadability, penetrability and durability" of Loprox when used to treat babies and toddlers with diaper rash.
-The defendants caused sales reps to deflect physicians' concerns about prescribing Loprox for diaper rash by supplying fals and misleading statements about studies demonstrating the safety of the drug.
-The defendants paid physicians for attending "advisory boards" and other meetings where the use of Loprox and Loprox TS to treat diaper rash was discussed. They also paid physicians for developing slide presentations promoting the use of Loprox for treating diaper rash.

In 2007, Medicis Pharmaceutical agreed to pay the United States $9.8 million to settle allegations that the company violated the False Claims Act with respect to claims submitted to Medicaid for treatment involving Loprox.

Also charged in the case is Ernesto Galvan, 45, Peoria, Ariz., who was Loprox Senior Product Manager.

Melgren commended the Food and Drug Administration's Office of Criminal Investigation, the Kansas Attorney General's Office and Assistant U.S. Attorney Tanya Treadway for their work on the case.


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