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By BarbaraHelene Smith

The employees at Triple A Labs, a family-owned research facility, gathered around a large table in the multi-purpose room anticipating an important announcement. ArtCure, the drug to treat a rare pediatric blood disease, was nearing approval by the Food and Drug Administration. Aroma of freshly brewed coffee radiated from ceramic cups as expectant electricity filled the air.

Conversations ceased when a tall, dark-haired man entered. Tony Abrams, the President's eldest son and Director of Regulatory Affairs, walked confidently to the front. He glanced at the casually dressed audience, some wearing white lab coats, then cleared his throat.

"Thank you for being so prompt," he began. "For the last few years, you have worked nonstop to research and develop ArtCure. The race is almost over and we're finally nearing the finish line." He paused. "The FDA will be conducting a pre-approval inspection starting next Monday." A few employees applauded. Tony smiled. "I don't have to tell you how important this inspection is to Triple A Labs and to me personally in getting ArtCure approved." Several employees lowered their eyes or nodded their heads knowing that Tony's four-year-old son suffered from the disease. "We must make sure everything is in order. I expect your complete cooperation."

Everyone in the room appeared enthusiastic, except one man. Marc Purdy sat silently with his fists clenched under the table. As soon as the meeting concluded, he rushed to his office, closed the door, and picked up the phone.

"Hey, Wolff. This is Marc Purdy from Triple A Labs. What the hell is going on? I just heard the FDA will be here next week to conduct an inspection. I thought we had a deal."

"I did my part. I got Orphan Drug status for your ArtCure product," the FDA reviewer said. "Pre-approval inspections are assigned by a different Division and not within my control." He paused. "Besides, you have a bigger problem. The statistical data for the Phase Three clinical trial failed to show that ArtCure is significantly more effective than the placebo."

"What? That's impossible." Purdy thought for a moment. "Compute the data again?"

"No, the numbers are solid. Facts don't lie."

"The drug must get approved," Purdy said. "Can you fix it?"

"Expediting an application is one thing, but falsifying data is another," Wolff countered.

"Look, I don't know what the problem is, but ArtCure is a good drug and should be approved. I kept my end of the bargain. I need your help."

"I've done enough for your company." Wolff hesitated. "It's not worth the risk. If anyone found out, it would destroy my career. I could go to jail."

"You're in it up to your neck in this already. Now's not the time to back down. Just do it," Purdy ordered and hung up.


SEVERAL MILES AWAY, Connie Murphy strolled into the FDA's Long Island Resident Post. As the long-legged brunette walked past the supervisor's office, RJ Marx shouted, "Murphy, I want to see you… Now!"

This can't be good first thing on Monday morning, Connie thought as she wheeled around to face the tall, slim woman with short, curly hair standing in the doorway.

"Your pre-approval inspection at Triple A Labs has been canceled," RJ announced.

Connie's jaw dropped. "What? Why?"

"I don't know. There was an e-mail in my inbox this morning."

"I don't understand," Connie said. "I prepared two days for that inspection. Why would they cancel it at the last minute?"

RJ shook her head. "Call Triple A Labs and tell them you won't be coming today."

Connie trudged into the bullpen, the large room she shared with five other investigators.

Dick, the other drug investigator, looked up from his computer. "Why the glum face?"

"My pre-approval inspection was cancelled."

"Triple A Labs? Weren't you going to start it today?" He frowned. "Isn't it unusual for an inspection to be cancelled on such short notice."

Connie nodded. "I'm going to call the BioResearch Monitoring Division to see if I can find out why it was cancelled before notifying the firm. Maybe it was a mistake."

Dick saw the puzzled look when she returned a few minutes later. "What did BiMo say?"

Connie pushed a strand of long brown hair behind her ear. "Only that the reviewer in charge of the application called on Friday to say he had to take leave, a family emergency or something, and cancelled the inspection."

Dick shook his head. "Just because the reviewer is on vacation shouldn't affect you conducting the inspection. Besides reviewers don't schedule inspections."

Connie shrugged. "Exactly. Something doesn't seem right."


DAYS LATER, CONNIE received a phone call from Faith Noon, a reviewer at the Center for Drug Evaluation and Research (CDER).

"I've been asked to take over Moses Wolff's application files," Faith began.  "I just e-mailed you an assignment to obtain copies of all the Investigational New Drug application (IND) documents that Triple A Labs sent to the FDA for review."

"Why do you need copies?" Connie asked.  "Doesn't CDER have the electronic file?"

Faith hesitated.  "The documents and correspondence from Triple A disappeared. They were apparently deleted."

"Deleted?  Did you ask the reviewer in charge of the application what happened to them?"

"We can't."   Faith paused.  "Moses Wolff is dead."






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