“The pharmaceutical industry is a laboratory for best practices in meeting planning,” said Christine Duffy, president and CEO, Maritz Travel Co., St. Louis, as she opened the First Annual Pharmaceutical Meeting Planners Forum, held March 31 to April 1 at the Hilton Philadelphia City Avenue. The meeting was co-produced byand the Center for Business Intelligence. “You can count on pharma to be in the forefront,” she said.
But the forefront often is not a comfortable place to be, as the planners from 22 pharmaceutical companies attending the meeting know all too well. “The expectations are greater, the time is shorter, and the challenges are many,” Duffy said. Among these challenges are external drivers, such as the economy, the political climate, and regulations like Sarbanes-Oxley, along with a slew of healthcare-related acts and statutes.
There also are new players on the field that meeting planners must work with, including procurement and corporate travel management departments, as companies consolidate meetings to rein in costs. In addition, planners are under pressure to measure meetings' return on investment — a term many of them find objectionable. Both the internal and external changes are creating an environment where it is increasingly important for meeting managers to become strategic leaders and increase their influence with senior stakeholders.
One thing became rapidly apparent as the sessions began: While each meeting planner was dealing with different corporate reactions to today's regulatory and market challenges, they had more in common than they thought. And while the challenges pharma planners face are multitude, the solutions kept circling back to communication, teamwork, and partnerships — especially among each other.
As Chris Pentz, CMP, president, Pentz Group Communications, Levittown, Pa., said in a panel discussion on future pharma meeting planning trends, “I remember when I first started going to industry shows as a pharma planner and was told to find the other pharma planners in the room — and stay away from them.” Now, at this meeting, planners from many companies came together to do more than share challenges and strategies — they developed a community of peers that they could rely on long after the meeting ended.
Geoffrey Levitt, vice president and chief counsel, regulatory and research, with Collegeville, Pa.-based Wyeth Pharmaceuticals, introduced the partnership theme with a lively session on how to work with a company's legal department. First, he said, you have to know why legal does the things it does. “Please understand that there are good reasons for wanting all that documentation — it's not just to bury you in paperwork.” (See the sidebar on page 22 for a regulatory rundown.)
Companies are responding to all the new pharmarules and regulations by developing internal policies and guidelines, Levitt said. For consultant recruitment, selection, and use, companies are requiring that the legitimate need for the service be outlined in advance; that healthcare providers are selected based on their experience/expertise, not prescribing habits; and that the company doesn't hire more consultants than it needs. These policies also cover consultant remuneration, which should be fair market value and given for legitimate, reasonable, and necessary services.
A more difficult policy to enforce is a yearly cap on the total remuneration given to any one healthcare provider, including pay, travel, meals, etc. “It's hard to track how much goes to each healthcare provider because that person might be used by different departments,” Levitt said. And everything has to be documented in a consultant agreement. “If [the feds] come after you, you want to show you have the agreements signed and policies in place,” he said.
In addition, companies are requiring that venues be “reasonable in cost and conducive to the consulting services,” and that the entertainment/education costs are balanced. “We don't have a secret book in our desk that puts a green light next to a certain hotel in a certain city,” Levitt said. “A resort might make sense, depending on the circumstances. The same might be true for entertainment; it might be fine to have a game of golf, but the educational purpose can't be secondary to the golf.”
Companies also are emphasizing training in these policies — “Until you train your people on your policies, they're just pieces of paper,” he said. “It protects the company and the person.” Wyeth requires every employee to receive training in the policies and get a score of at least 90 percent on a test. “Everyone had to take the test, including me,” he said. “Can you imagine if the regulatory affairs person flunked?” he said, to everyone's amusement.
When working with third parties, it's important to make sure everyone involved understands the rules. “If a third party comes to me with something that looks bad, I have to help them fix it or walk away,” said Levitt. “If you're a third party and a company person comes to you with a bad idea, the same thing applies.” But ultimately, he said, any impropriety would be the company's responsibility, so the onus is on the pharma planner to make sure everything is above board.
Once you understand the pressures companies are under and the policies they have created in response — “what's behind them, not just what they are” — Levitt suggested that planners work with legal to develop templates for meeting planning that address areas of concern. He also suggested involving the legal and regulatory affairs department when discussing long-term plans for medical meetings to make sure everything is OK from the start. Another idea he proposed was to provide to the legal department — far enough ahead of time to allow for a thorough review — any draft meeting materials that require internal company sign-off. “Make emergency sign-offs the exception, not the rule,” said Levitt.
Another department planners need to learn to play well with is procurement. “Procurement is not a four-letter word,” said Judy Benaroche Johnson, CMP, president and CEO, Rx Worldwide Meetings, Plano, Texas, during a session she led about choosing preferred vendors and third parties. “It is a way to guide purchasing decisions, reduce costs, centralize the purchasing process, commit to a specific dollar amount, maintain consistent branding, and track payments more efficiently.” She added that it usually involves different departments sharing their best practices with the procurement department to leverage meeting spend.
Novartis has had pretty spectacular success in implementing such a process, according to presenters Steven Chyung, chief procurement officer, strategic sourcing, and Paul Tomaszeski, executive director, business support services, Novartis Pharmaceuticals North America, East Hanover, N.J. During a case study presentation, Chyung explained how he has helped to lead the transformation of Novartis' procurement department, which supports close to $2 billion in third-party indirect spend across the Americas, from a mainly logistical function to a more strategic one. The entire consolidation process not only captured $53 million in 2004 meeting spend, but also consolidated the core roster of medical education and event management companies Novartis used, improved the med ed and event management processes, established cost per attendee per meeting type, and benchmarked Novartis' performance against other pharma companies.
Chyung and Tomaszeski showed a humorous video explaining exactly how the Novartis process works, with a smooth partnership between internal departments that sign off on the budgets, sourcing experts, and meeting planners. “Nailing down the roles and responsibilities of each was important,” says Chyung. He added that they worked with human resources to introduce the event consolidation plan to the vice presidents of the different groups that sign off on the meeting budgets, then told them they could keep the money they save if they had 85 percent compliance with the consolidation plan. If they didn't reach that goal, they would lose those dollars.
Another big change: Novartis peeled the number of med ed companies they used from more than 100 to a core roster of just 15, and whittled its 36 major event suppliers down to just four. Novartis sees synergy between travel, event sourcing, and meeting planning, and organizes those functions under Tomaszeski's team in business support services.
On the supplier side, “Preferred vendors have to identify their core competencies, show quantifiable data on cost savings or cost avoidance, and be able to work differently than they have in the past,” said Johnson in her session. “The procurement professional doesn't want to be the meeting professional.” To get proactive in her relationship with procurement departments, Johnson reads articles on how procurement departments work, and researches what's going on both with her client companies and with their competitors. And, because procurement departments tend to be data-intensive, third parties should ensure that they also have data-intensive systems in place.
In a town-hall-style session led by Carol Krugman, CMP, CMM, president and CEO, Krugman Group International, St. Petersburg, Fla., the audience explored what works and doesn't work in the relationships between medical education/meeting planning companies and their corporate clients. One pharma planner in the audience eludes the problems altogether by not hiring third parties: “We save $20 million by keeping it all in-house.” Another audience member countered, “I've seen companies who take everything in-house and say, ‘Look how much we save.’ Then they say, ‘Well, now we have to pay these people even during slow times. Let's outsource.’”
One medical education planner in the audience said a common problem was that thecovered only content development, but the pharma company kept adding more services. “We'd love to do it all, but it's not in our contract.” Another complaint from the third-party planner side was, “Why are we being segmented as just logistics managers? We have worked so hard to be strategists” — a comment that received much applause. Michael Galindo, medical program financial manager, Merck & Co., Rahway, N.J., who served on Krugman's panel, said, “We consolidated preferred vendors a while ago. More recently, we unbundled services.” Krugman explained that “unbundling” means separating out various meeting components and assigning them to different agencies according to their core competencies, such as site sourcing, content development, registration/housing/travel, and on-site logistics management. Even though the components are separated, the coordination and monitoring are still centralized within the company. Galindo added, “We developed a communication process to use between finance, the clinical team, and logistics [vendors]. That's helped a lot.”
Krugman had a different twist: “Among our client base are med ed and other planning companies. When the client wants to split out logistics from content, these other third parties hire us to help when they lack the expertise required to do what their client wants.” She added that, because her company has extensive international experience, small boutique med eds pull her company in when they're doing international meetings. “We present our capabilities to the client together, and the client knows we're involved. The other med ed company keeps the general services contract, and we split the fee. Larger med eds who prefer that we work under their name just sub the international logistics out to us. And still others are forced to work with us sometimes, when we have a client in common who prefers that we manage the logistics. This happens frequently for meetings in Latin America, where we have considerably more expertise and connections than most companies. Whatever the arrangement, we can no longer rely on what we relied on in the past. It's different now, folks, and if we don't find new ways to work together, those of us who want to remain small and specialized will not survive.”
One delegate from a meeting planning company got heads nodding when she said, “One frustration of working with a med ed company is the power struggle and resistance to working with other third-party independents. They don't easily cooperate when we're hired to do the ‘planning’ and they do the content development — there needs to be more shared respect and cooperation among vendors. We're on the same side.” Another audience member brought down the house with this comment: “The frustration is that we all want service, service, service, but we don't want to pay for it. We need to value each other's expertise.”
In addition to discussing challenges with their third-party colleagues, in-house pharma planners had the opportunity to share frustrations and solutions among themselves. At a closed-door session for pharmaceutical meeting planners led by Stephanie Bertrand, project manager, Sepracor Pharmaceuticals, Marlborough, Mass., the talk quickly turned to professional development, and how planners can achieve a more strategic status with their companies through gaining more control over the budgeting process. The question under hot debate was how to work more closely with the managers of the different product groups and the finance department to make that happen.
One planner outlined her strategy: “Because management's business is pharmaceuticals, not meeting planning, they don't necessarily have a good grasp on what's needed for their meetings. It's all about going to management and saying, ‘Your spend isn't what you think it is because it's coming from many different buckets.’ You have to show the true dollar figure to the right people; then they'll turn to you to do the budget.” Another planner added, “We have to educate others on how valuable the program is to the stakeholders.”
One way to start the education process is to put together budgets for every possible configuration and contingency a meeting might face and present it to the finance department, said one planner who had done just that a few years ago. “So if a three-day turns into a four-day, or they have to fly instead of drive, finance already has the change of plan.”
Some planners also felt a little out of the loop, being shuffled from department to department: “We're an anomaly. They don't know what to do with us. Is meeting planning sales, marketing, or something else?” One planner answered, “I position my department as a service group and report to human resources. If the budget comes from sales, we're servicing sales as our customer. If we have two groups involved, we have a meeting well ahead of time with both key stakeholders. We develop the program together. It's painful, but it works.”
Another planner said, “I work directly with the CFO to develop the budget; I give him the numbers based on history. We're able to shift money around if one group comes up short and another goes over. If someone comes up with a new meeting, they either have to make an exchange with another program or come up with a new budget for it. You have to sit down with the business owner and get buy-in all along the way.”
“Finance is your friend,” said another planner, who prepared a flowchart of all the different meetings being charged to different departments and presented it to the finance department. “I showed them what's really going on. That's how we got them to budget directly to us. If you're still charging out to the different departments, take the full picture to finance and get the comptroller behind you.”
Speaking of money — attendees also had concerns about travel reimbursement, honoraria, and speakers who don't want to abide by corporate policy or the PhRMA Code on Interactions with Healthcare Professionals. Some rein in speakers by abiding by the same rules they use when making arrangements for internal personnel; others ask that thego through the company's travel department. “If the speaker wants to use his own agency to get the mileage points, tell him that you'll reimburse him up to the cost of the coach ticket your travel department found for him.”
Other advice was to train speakers in the PhRMA Code — and even send a copy of the code with each speaker contract. If doctors still want more than you can reasonably give, just stand firm, they agreed. In the event a physician says, “I'll never prescribe your drug again because you won't pay for my spouse, delegates suggested responding, “I hope you will do what's in the best interest of your patients.”
At the end of the session, the feeling of solidarity and connection among attendees was palpable. As one planner said, “I have felt kind of alone, like I was the only one dealing with all these issues. I feel so much better knowing you all share my pain.”
Pharma planners need to understand how government scrutiny and regulation of drug companies' marketing practices affects meetings, said speakers Geoffrey Levitt, vice president and chief counsel, regulatory and research, with Collegeville, Pa.-based Wyeth Pharmaceuticals, and Jean-Ah Kang, PharmD, senior regulatory affairs consultant with Scientific Applications International Corp., Frederick, Md. During their sessions, which opened the Pharmaceutical Meeting Planners Forum, they outlined the various laws, codes, and regulations that govern pharma today.
The Food, Drug, and Cosmetic Act covers advertising and promotional materials distributed by a manufacturer, but it doesn't stop at a brochure. “Advertising and promotional materials have a broader interpretation,” said Levitt. “Any communication issued on behalf of the company that deals directly or indirectly with the company's products could and probably would be considered to be promotional.” That's why meeting planners need to make sure their materials are not false or misleading, don't promote off-label use, and present a fair balance between the product's risks and benefits, as required under the FD&C Act.
The False Claims Act, “an old law [the feds] are now using to crack down,” said Levitt, “imposes civil liabilities on companies that defraud the government,” and potentially also imposes liabilities for any off-label promotion that results in government reimbursement, and allows for qui tam, or whistleblower, enforcement. The latter is becoming increasingly important as Congress is “talking about forcing companies to inform employees about the benefits of whistleblowing. That's an indication of the environment we're in now,” he said.
Then there's the Federal Anti-Kickback Statute, which prohibits companies from giving items of value to induce a customer to buy its product, if its product is reimbursable by a federal program such as Medicare or Medicaid. Many states also have their own version of this statute. The Office of Inspector General, which issued its Compliance Program Guidance for Pharmaceutical Manufacturers two years ago, now is looking at consultant meetings for possible violations of the anti-kickback laws. “Business courtesies for those in a position to influence referrals also can trigger the Anti-Kickback Act,” Levitt added.
In addition, there's the PhRMA Code on Interactions with Healthcare Professionals which, while voluntary, recommends that there be a legitimate need for a consultants meeting, that selection criteria for attendees be tied to their experience and expertise, and that the venue be conducive to the services provided.
And there are lots of teeth behind the regs these days, including expensive settlements in the high-profile examples of TAP Pharmaceutical Products Inc., and the Neurontin case that Pfizer inherited when it bought Warner-Lambert. “Times have changed,” said Levitt, of the allegations that Warner-Lambert took physicians on lavish trips to resorts under the guise of consultant meetings and paid opinion leaders or high-prescribing physicians to act as consultants without requesting significant service in return, thus triggering the Anti-Kickback and FCA laws. “This was not uncommon behavior when these violations occurred,” he added.
But while practices have changed, the regulatory backlash continues to intensify, Levitt said. And companies that violate the rules incur more than financial risks. In addition to settlements, companies such as TAP and Pfizer were required to enter into corporate integrity agreements with the government that laid out policies and procedures for speaker and advisory board meetings, consultant arrangements, and employee training. The agreements are good for at least 10 years, depending on the company's demonstrated compliance.