These are not the Best of times for the pharmaceutical industry. More regulations, increased federal scrutiny, pricing pressures, and a tarnished public image all cloud the present — and future — of the industry. But along with these challenges come opportunities for meeting professionals — opportunities to not only elevate their status within their companies, but also to help the industry as a whole, said Michael W. Young, senior director, global oncology strategy, Eisai Inc., La Jolla, Calif., the keynote speaker at the Third Annual Pharmaceutical Meeting Planners Forum.

In a forthright, often sober, but ultimately inspiring address, Young, a previous Medical Marketing Association, “Medical Marketer of the Year,” told the nearly 1,000 meeting professionals in the audience at the Pennsylvania Convention Center in Philadelphia that they are “more vital to their organizations than ever before,” serving as logisticians, marketers, strategists, and compliance gatekeepers in today's highly regulated environment. They also play a critical role in improving the beleaguered image of the industry and substantiating the value of pharmaceuticals as a means to save lives and improve the quality of life for patients.

Indeed, meetings are the public face of the industry, the educational conscience, and an important stop along the prescription pathway.

Tarnished Image

Citing a survey published in January 2007 by Pharmaceutical Executive, Young said the No. 1 concern of executives is the industry's image. Americans believe that drug companies put profits over safety. In fact, he said, patient safety is high on the list of pharmaceutical executives' concerns. “More people are alive today and have a better quality of life because of the work that we do.”

The political environment is another concern among executives. “I can't overstate the potential impact of the shift in Congressional control,” said Young. The new Democrat-controlled Congress is likely to consider a number of measures that could affect the industry, including efforts to regulate drug pricing, restrict research into disease states where multiple alternative treatments already exist, ban authorized generic drugs, allow the importation of drugs from other countries, and revise Medicare Part D in a way that would, in effect, drive older Americans to generic drugs. Further, the high cost of bringing a new drug to market (close to $1 billion), the lack of near-term blockbuster drugs in the pipeline, and pricing pressures could put financial stress on pharmaceutical companies, executives fear. That could lead to increased consolidation and job market shifts, Young said.

The Prescription Pathway

Pharmaceutical executives are also concerned with the effectiveness of drug marketing, said Young. The results of a recent study by the UCLA Center for Health Policy and Research show why.

Many patients lack an understanding about the drugs they are prescribed, the study discovered. Only 15 percent of patients understand what their healthcare provider has told them; nearly 50 percent leave the office not knowing what their specific treatment plan will be; 50 percent fail to take their medications correctly; and 30 percent of all prescriptions are never filled.

Meetings play a big part in making sure that healthcare professionals and patients know how to get the most out of prescriptions and clear up the confusion, he said. “Industry supported programs, including meetings and medical education programs, must achieve better results or we as an industry won't be able to sustain the value proposition of pharmaceuticals,” stated Young.

Meetings are critical junctures along the pathway to prescriptions, Young said, because they intersect with all the key stakeholders: patients, caregivers, doctors and other healthcare professionals, and payers. Meeting planners directly impact the outcome of patient care through the creation and management of the environment in which the educational or marketing message is delivered. They need to be “patient-centric” in the way they approach meetings. “Everything we do must contribute to the improvement of patient well-being and safety,” he said. “Build your meetings on the foundation of sound medicine and good business practices,” with a dedication to providing lifelong learning for healthcare professionals.

He closed the presentation with a quote from Elizabeth Edwards, the wife of presidential candidate John Edwards, who disclosed in March that her breast cancer had recurred. “I expect to do next week all the things I did last week, and the week after that and next year at the same time, all the same things I did last week. I don't expect my life to be significantly different,” Young quoted Edwards as saying.

“That's our job,” affirmed Young. “That's our calling at every level in this industry and in this room — to make sure that her life won't be any different.”

Compliance Is King

The issues raised by Young, particularly about the regulatory environment, permeated the conference. Compliance was a hot topic during many sessions — from a boot camp workshop to a summit for senior-level planners.

“Compliance is king. It's the issue du jour in the pharmaceutical industry,” said Jeffrey Lenow, MD, associate professor, department of family and community medicine, Jefferson Medical College at Thomas Jefferson University, Philadelphia, and a presenter at the lively and packed boot camp workshop.

“In the last year, our role has become as much about compliance as it is about meeting planning,” said one veteran pharma planner. “We are the police. We oversee pharmaceutical meeting compliance, so we have to make sure people follow the rules.”

“There's more pressure on the legal department, and pressure on us to select appropriate venues for our programs, not to give out inappropriate gifts, to ensure a more business-oriented atmosphere as opposed to a pleasure-focused atmosphere,” said one participant in the senior planners summit.

“Compliance is very important to us,” added Marianne Demko-Lange, director, meeting planning support at Wyeth Pharmaceuticals, Collegeville, Pa., speaking at a thought-leaders session. Demko-Lange is one of 20 “quality champions” appointed throughout the company to oversee compliance in their respective areas.

In addition to the guidelines promulgated by Pharmaceutical Research and Manufacturers of America and the U.S. Office of Inspector General, individual states have instituted their own laws related to pharmaceutical marketing, explained speaker John Oroho, Esq., principal at the Morristown, N.J.-based law firm, Porzio Bromberg and Newman; and executive vice president at Porzio Pharmaceutical Services. Vermont, Maine, Louisiana, the District of Columbia, West Virginia, Minnesota, and California have laws that require pharmaceutical companies to disclose their promotional expenditures for healthcare professionals. Colorado is considering similar legislation, while lawmakers in Massachusetts are debating legislation that would ban gifts to physicians altogether.

“It's a new compliance landscape,” said Oroho. “Now, you have 50 attorneys general to worry about.”

Planners need to know the laws in the state in which they are meeting as well as the restrictions in the states where the physician attendees reside because healthcare professionals are subject to local laws, he added.

Experts recommend that meeting planners work with internal legal and compliance teams to educate the vendors they hire — and the subcontractors the vendors use — on pharmaceutical industry regulations.

“Compliance is about systems and data,” said Lenow — that is, establishing processes to make sure everyone along the meetings “food chain” knows the rules and adheres to them, including suppliers. Now, pharma must be accountable for all kinds of statistics, including spend for speakers and venues. Systems that are capable of sorting data and flagging, for example, that a certain physician speaker has reached the company's allowable consultancy fee for the year are critically important. Data integrity and reliable systems to “match the ever-growing complications of reporting accountabilities are vital to the industry,” Lenow said.