Life Sciences

PhRMA Code's revised guidelines contain some surprises

Pharma Compliance Alert, July 16, 2008

The PhRMA Code’s elimination of small, practice-related gifts to healthcare professionals came as a surprise to healthcare attorney Linda Pissott Reig, a principal at Prozio, Bromberg, & Newman in Morristown, N.J.
 
“I always thought they were so nominal in value and helpful,” Reig says of the reminder items such as pens, coffee mugs, and note pads. “I never saw them as a potential influence (on prescribing habits).”

The Pharmaceutical Research and Manufacturers of America (PhRMA) released updates to its voluntary Code on Interactions with Healthcare Professionals on July 10. The new guidelines take effect January 2009.  

In addition to prohibiting small gifts and reminder items, the revised Code:
  • Prohibits company sales representatives from providing restaurant meals to healthcare professionals, but allows them to provide occasional meals in healthcare professionals’ offices in conjunction with informational presentations
  • Includes new provisions requiring companies to ensure their representatives are sufficiently trained about applicable laws, regulations, and industry codes of practice  
  • Provides that each company will state its intentions to abide by the Code and that company CEOs and compliance officers will certify each year that they have processes in place to comply
  • Includes more detailed standards regarding the independence of continuing medical education
  • Provides additional guidance for speaking and consulting arrangements with healthcare professionals
Dan Kracov, a partner with Arnold & Porter in Washington, DC, calls the revised Code “a very positive development” for the industry, but adds complying with the changes will require a significant effort.
 
Tracking aggregate spending is one of the biggest challenges for pharmaceutical companies, Kracov says. Some companies do not have a system that will accurately record aggregate spending across the organization.
 
Training employees is another. “It’s going to be a challenge getting everyone on the same page,” Reig says.
 
But Kracov believes pharmaceutical companies can benefit from the changes as well. The new guidelines could help the industry regain public trust after “just getting shelled” and constantly being accused of wrongdoing, Kracov says. In addition, some companies will be relieved they can reduce their spending on traditional marketing activities, Kracov says.

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