Exton, PA, September 2, 2003 – "No pharmaceutical company is immune from investigation," said Franklin A. Kurtz, President and CEO of CimQuest, Inc., Exton, PA-based leaders in systems regulatory compliance for pharmaceutical, biotechnology and medical device manufacturers.
"The Prescription Drug Marketing Act (PDMA) is being rigorously enforced by the FDA and the Department of Justice," Mr. Kurtz added. "Billions of dollars in fines have already been levied against major, world renowned pharmaceutical makers. Violating PDMA could land corporate executives in jail for as long as 10 years. Individual whistle-blowers can earn themselves millions of dollars for spotting PDMA violations, as well," he said. (See Penalties Chart below).
Mr. Kurtz stated, "Through our unique Hi-Q/PDMA™ program, CimQuest helps pharmaceutical companies mitigate the risks of violations, prioritize risks in order to develop a specific project, and drive activities to a state of compliance and control. Our multi-tiered approach provides professional, certified expertise for execution and compliance of business processes, sample accountability, sales force automation, and assessment and validation computerized systems in accordance with the Prescription Drug Marketing Act implemented with 21 CFR Part 203 and 21 CFR Part 205."
Ms. Gale Robinson, CimQuest's Subject Matter Expert (SME) on PDMA, explained, "PDMA was enacted to address certain prescription drug marketing practices contributing to the diversion of large quantities of drugs into a secondary grey market. The marketing practices included distribution of free samples, use of coupons redeemable for drugs at either low or no cost, in addition to the sale of deeply discounted drugs to hospitals and health care entities. As a consequence, a multi-million dollar drug diversion market formed, providing countless opportunities for mislabeled, sub-potent, adulterated, expired, and counterfeit drugs to enter the nation's distribution system."