Lynn Shapiro Snyder, a Senior Member of the Firm in the Health Care and Life Sciences Practice in the Washington, DC office, was quoted in BNA’s Health Care Daily Report on the need for device and drug companies to augment compliance plans with adequate training of salespersons to avoid a government enforcement action based on advertising and marketing violations.
The article, “More Than Compliance Plan Needed To Avoid Enforcement, Attorneys Tell Meeting,” reported on a Sept. 22 meeting sponsored by the Food and Drug Law Institute (FDLI) that Snyder moderated. The meeting was titled “The FDLI’s Conference on Advertising and Promotion for the Drug, Medical Device, Biological and Veterinary Medicine Industries in Cooperation with the FDA.”
Snyder said that training of companies’ sales forces is essential to ensure the success of a compliance program. She advised that training be “generational,” noting that studies have shown that gen-Xers learn differently from baby boomers and that gen-Yers are different yet.
Snyder also remarked that, in international arena, cooperation is in place in the areas of intellectual property and antitrust, but the same level of cooperation is not happening when it comes to fraud.
On the other hand, she said, there is beginning to be cooperation between entities that have stakes in ensuring compliance within the United States. For example, the federal government, enforcing federal
Medicare-related laws and the anti-kickback statute, is cooperating more with state governments enforcing Medicaid provisions. But there is still a long way to go, she said.