Urofollitropin

A Brooklyn plumber who spent six months in prison for selling counterfeit fertility drugs continues to serve out a three-year probation. Convicted in 1995, David Braun also had to pay $725,000 to the company whose two drugs were illegally copycatted.

FDA continues a multinational investigation of others who were involved in the scheme, including the man FDA's Office of Criminal Investigations suspects was the operation's "kingpin."

Braun's involvement was discovered in a three-month investigation in which OCI agents gathered evidence showing that Braun ran a shell company--an answering service with a fictitious name and address that took orders for the fertility drugs Pergonal (menotropins for injection) and Metrodin (urofollitropin for injection). The evidence showed that Braun delivered fake copies of the drugs to U.S. drug wholesalers, giving them huge discounts of as much as 20 percent off the average wholesale price.

The manufacturer of genuine Pergonal and Metrodin, Serono Laboratories Inc. of Norwell, Mass., contacted OCI in September 1993 to report that some unusual-looking drugs and their packaging brought to the company's attention had been tested and found to be counterfeited.

Serono also told OCI they had noticed an unexpected drop in sales of Pergonal and Metrodin during the previous 18 months.

FDA "hit this investigation hard," says OCI Special Agent Brian Krompasick, noting that 14 of OCI's New York agents, as well as agents from Miami, Chicago, and Washington, D.C., were involved. "For the public safety, we wanted to stop these drugs from going into the stream of commerce."

While FDA knows of no injuries from the imposter drugs, the agency's concern was that the drugs could pose a danger because they were not manufactured according to FDA's safety and effectiveness standards.

Also, says OCI Special Agent Stephen Haynes, "It seemed likely the case involved a sophisticated and organized network reaping millions of dollars in fraudulent profit."

Braun was selling the fake fertility drugs for a wholesale price of about $380 for a one-month's supply, compared with $460 for the real Pergonal and Metrodin.

To catch Braun at work, OCI got the help of a major Serono distributor who had been approached in September 1993 about buying the fakes. In September and October 1993, the distributor arranged to have more than $500,000 worth of the fertility drugs delivered. When they were delivered, OCI seized all the batches, which were later tested and found to be fakes.

The distributor--or agent Krompasick posing as the distributor's accountant--was wired to record the conversations with Braun and other suspected counterfeiters during the deliveries.

For additional evidence, FDA set up an undercover operation outside the distributor's warehouse on Oct. 28, 1993.

While an OCI agent sat in his parked car, one of the suspected counterfeiters arrived at the warehouse and couldn't find a legal parking spot for his van. So he double-parked--right next to the agent's car.

Outside the van, the suspected counterfeiters discussed the terms of the deal with the distributor. "They were almost leaning on our car," Krompasick says. "Our agent was so nervous. He's in the car--police radio and all--right under their noses."

After photos taken by the OCI agent were enhanced by an FBI lab, says Krompasick, "it was undeniable that Braun and his van were at the meeting."

But FDA wanted to find the source of Braun's drugs. So, as planned beforehand, when the suspected counterfeiters' delivery man brought another load of drugs to the warehouse, the cooperating distributor told him that FDA was onto the scam, and he couldn't accept the delivery.

OCI agents then followed the delivery car as it left with the rejected drugs. They saw the delivery man meet Braun in Brooklyn, where the two loaded the boxes of drugs into Braun's van.

"Because of the heavy traffic and dark, we made the decision to arrest Braun then and there," Krompasick says. "Braun was oblivious to the surveillance; he didn't know what hit him."

While searching Braun and his van, OCI agents found his wallet with identification, as well as blank invoices with the fictitious name and address of the shell company and two metal dye stamps like those that would be used to print the fraudulent packages.

"When we found those things, we knew we had one of our counterfeiters," Krompasick says.

Braun pleaded guilty to conspiracy to sell misbranded drugs and was sentenced Nov. 8, 1995, in the U.S. District Court for the Eastern District of New York. In addition to prison, probation, and the money he was ordered to pay to Serono, he also had to perform 250 hours of community service.

Within two weeks of Braun's arrest, Serono saw a recovery in sales. "It appears we've shut this counterfeit group down," Krompasick says.

COPYRIGHT 1997 U.S. Government Printing Office
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