Keeping Up With Med-Pharma Codes

Last summer, New York City-based pharmaceutical behemoth Pfizer changed the name of its meetings department. The group formerly known as Pfizer Meetings and Conventions morphed into Pfizer Compliant Meetings and Controls. The change underscores the shifting responsibilities that planners in the medical/pharmaceutical industry must cope with, thanks to an ever-growing series of guidelines and controls that govern pharmaceutical marketing and interactions with physicians.

In the past, the Pfizer meeting manager's role hadn't been one of enforcing compliance, according to Lisa Keilty, CMP, team leader in the department -- but in the past six years, that's what it has become. "Those outside of pharmaceutical meetings management just didn't understand the level of detail in what we do, and the level of risk that we keep the company away from," she notes.

For planners in this niche, the pile of codes is a growing tangle augmented by state, federal and international legislation. In the face of heightened public scrutiny and government pressures regarding ethical issues, this past year brought updates to two sets of guidelines:

• Code on Interactions with Healthcare Professionals, from the Pharmaceutical Research and Manufacturers of America (PhRMA; took effect Jan. 1), and

• Code of Ethics on Interactions with Health Care Professionals, issued by the Advanced Medical Technology Association (AdvaMed; took effect July 1).

These two voluntary codes address ethical concerns between health-care practitioners and drug companies (PhRMA), and health-care practitioners and medical- device manufacturers (AdvaMed). The revised versions put the kibosh on noneducational giveaways (such as pens and mugs with company logos) and attempt to clarify policies regarding meals, speaker compensation and the like -- anything that might be construed as the drug or device company attempting to exert influence over the physicians. (See mcmag.com/webexclusives for a look at other influential entities.)

Open to interpretation The latest PhRMA and AdvaMed codes offer some fairly subjective guidelines, such as the following, taken from Chapter 2 of the PhRMA code, "Informational Presentations by Pharmaceutical Company Representatives and Accompanying Meals."

In connection with such presentations or discussions, it is appropriate for occasional meals to be offered as a business courtesy to the health-care professionals as well as members of their staff attending presentations, so long as the presentations provide scientific or educational value and the meals (a) are modest as judged by local standards; (b) are not part of an entertainment or recreational event, and (c) are provided in a manner conducive to informational communication.

Clearly, different parties might have varying definitions of "modest" meals and surrounding circumstances. The code's tone -- at once detailed and open to interpretation -- is intentional. The trade group behind the advice can neither lay down the law nor enforce it.

"These are self-regulated codes," underscores Teresa Bria, vice president of projects and operations for Phase to Phase Strategy LLC, a planning company based in Weston, Conn., that works with pharma clients. "Each company responds to them in subtly different ways. If you read them, it's not necessarily difficult to understand the PhRMA code, for example, or the OIG [Office of Inspector General] guidelines. In our day-to-day practice, it's more challenging to keep up with the ever-changing interpretations that each individual company has. What one company might think is modest, another might define differently."

Of concern, adds Bria, is that spending limits keep plummeting as a result. "The amount we can spend on a health-care professional's hotel room or meals continues to decrease," she says. "This is not only difficult for planning, but frustrating because public perception is that pharmaceutical companies spend large amounts of money entertaining physicians -- which is far from the truth."

Keeping tabs "Companies are putting in more processes, especially for documentation purposes," says Teresa Bria. "Did the meeting actually happen? Who actually attended it? What was said at the meeting? How much was spent on each person? As the guidelines become stricter and companies refine their interpretation, they absolutely are clamping down."

Pharmaceutical meeting managers play an essential role in implementing and enforcing the controls so important to maintaining the company's reputation, explains Pfizer's Keilty, and that's what motivated her department's name change. Their role is critical to public relations, in these days of heightened scrutiny and public perception.

Pharmaceutical meeting managers are helping to design standard operating procedures and develop the documentation required to legitimize every transaction. They are instrumental in determining pricing thresholds and setting up the processes for approval when those guidelines are exceeded.

Among factors driving the need for documentation is preparation for the pending federal Physicians Payment Sunshine Act. The measure, still in debate, will call for transparency of speaker payments, doctor meals and the like, enough so that companies will have to track spend down to the attendee level. "I see a huge amount of additional paperwork coming our way," predicts Bria.  

Planners who work with drug companies in any capacity already are feeling the effects of these efforts. Nancy Arendt, director of education for the Atlanta-based Medical Association of Georgia, depends on pharma company grants for many of her educational programs. Requesting those grants already has become a far more bureaucratic process.

"The grant requests are all standardized and online now," explains Arendt. "They're very in-depth and they ask a lot of questions." What's more, they've changed the dynamic of business interaction. Previously, Arendt might have dealt directly with a district manager, for example. But processes have become more centralized. "You now have a very different relationship, because all of the grants go through a computerized process," she says. "It takes that relationship away from you in a sense, makes it less personal."

Conventional impact The degree to which the codes have affected conventions is open to speculation, says Eric Allen, executive vice president of the Healthcare Convention & Exhibitors Association in Atlanta. His organization has yet to acquire and analyze any hard statistics regarding convention and exhibit attendance in 2009; but even when that happens in the early part of this year, isolating the effect of code changes from those of the weak global economy, not to mention state-specific pharma legislation, will be difficult.

Reports from the marketplace are mixed, says Allen, "and heavily dependent on the medical specialty you're in." Areas such as clinical oncology -- in which breakthrough therapies or products are hitting the market -- have seen at least as much activity on the show floor and in the exhibitors' booths as in previous years. "Learning about new products that are commercially available -- or soon to become commercially available -- is a powerful driver of attendance to the exhibit floor," he adds.

A medical field with fewer announcements, or fewer products in the pipeline, is more likely to see a drop-off in exhibit attendance. Exhibitors and show organizers have to analyze that on a case-by-case basis, Allen points out, to determine what effect fewer giveaways and a more restrictive atmosphere have had on any such declines. "I don't think [giveaways or promotions] were ever a major educational driver," he notes. But in cases where they had any effect at all, it could be harder now for exhibitors without any big product announcements to draw attendees to their booths.

Putting heads together Despite industry competition, Lisa Keilty believes the current challenges are helping to bring people together. "Every time they have a new iteration of the PhRMA code or the need for transparency increases, there's more collaboration within the industry," she says.

Keilty is the president of a new industry group, the International Medical Meeting Professionals Association, which aims to provide a forum for the exchange of best practices for medical meeting planning (see "Introducing IMMPA"). "All of us working together will help to provide greater transparency of how the industry operates," she says. "And that, hopefully, will reduce all of the complexity."

Web exclusive Pharma code changes and attendee confusion: mcmag.com/webexclusives