OIG issues guidance on drugmaker gifts

Nonmedical inducements to prescribe products could put doctors and pharmaceutical companies at odds with the government agency.

By Andis Robeznieks, AMNews staff. May 19, 2003.

The U.S. Office of the Inspector General's new Compliance Program Guidance for Pharmaceutical Manufacturers warns drugmakers that some long-standing practices -- including gifts to doctors, medical education sponsorship, and physician consulting arrangements -- may violate federal anti-kickback laws.

The law is defined as "a criminal prohibition against payments ... made purposefully to induce or reward the referral or generation of federal health care business."

The OIG released the 56-page guidance on April 28. Agency spokeswoman Judy Holtz stressed that the guidance is a voluntary program issued to help companies stay in compliance with federal laws.

"A lot of this is common sense," she said. "Some of this is very low risk. We're not saying they can't do it, just that some of it is a potential risk and you can do it if you don't do certain other things."

For example, the guidance states that drug firms can fund continuing medical education programs if the companies "separate their grant-making functions from their sales and marketing functions."

Grant Bagley, MD, a partner at the Washington, D.C.-based law firm of Arnold & Porter, scoffed at the notion that complying with the guidance was voluntary. "You wonder how voluntary it's going to be," he said. "It's coming from the people who decide what they're going to enforce and who they're going to go after. When the 800-pound gorilla says, 'This is voluntary,' what are you going to do?"

Dr. Bagley also warned that problems could arise because the guidance weighs heavily against any inducements to prescribe.