If you work with third-party vendors, such as medical education or meeting planning companies, you have to heighten — not relax — your vigilance about compliance with the new regulations, said panelists at the National Pharma Congress Audioconference held in September. The conference addressed steps pharmaceutical firms can take to comply with the Office of Inspector General's pharmaceutical guidance and avoid violating federal fraud, abuse, and anti-kickback laws.
When planning advisory board and consultant meetings, “there is a false perception that once you use a third-party vendor, you can wipe your hands of the problem. That's not the case,” said Marc Farley, assistant general counsel and compliance officer, Berlex Laboratories Inc., Montville, N.J. Vendors have to follow the same rules as pharma firms, agreed Arjun Rajaratnam, compliance officer,pharmaceuticals, GlaxoSmithKline, Research Triangle Park, N.C. “I urge everyone to track your vendors, your med-ed companies, your meeting planners.”
Far from mitigating the risk, vendors can exacerbate your problem, if they're not knowledgeable about regulations and compliant with them. In order to please their customers, medical education and advertising agencies often document their efforts, said James Sheehan, assistant U.S. Attorney, chief, civil division, Eastern District of Pennsylvania, Philadelphia. “So you see these reports that say: Before the doctors got $50 chocolates on their pillow, they only wrote so [many prescriptions]. After they got the $50 chocolates, they wrote twice as [many prescriptions].” Sheehan, who has prosecuted many prescription drug cases, explained that such documentation makes cases appealing to the government. “Pharma companies, inthose relationships, have outsourced their control,” he said.
To protect yourself, “consider making the vendor articulate in writing why each advisory board participant was chosen,” Farley suggested. “They're going to balk about that, but it has worked in certain circumstances. You can also consider providing a sample recommendedthat the vendor will use with the physician or advisory board participant.”
How can vendors, such as medical education companies, be better compliance partners for their pharmaceutical firm clients? Vendors should implement compliance policies, procedures, staff training, and controls over the employees who are conducting regulated activities, said Rajaratnam. Vendors that do have a rigorous compliance program in place will have a competitive advantage, the speakers agreed.