For the moment, says Andy Bender, president of Polaris Management Partners, top concerns will include:
Off-label promotion "We haven't seen the end of it," says Bender. "I don't think we're even seeing the peak yet."
Publications and clinical trials "OIG will be looking at proper disclosure on independent investigator studies," Bender says, "how they're being conducted,
who wrote the conclusions, et cetera."
Training Bender's colleague Judith Braun-Davis, compliance specialist at Polaris, explains: "The last couple of years, everybody has
been doing policy and process. Now it's implementation time."
Bender predicts that new compliance initiatives will drive major changes in sales and marketing. "Companies are being requested
to report how much they spend on physicians," he says, "and that forces companies to start tracking how much they're spending.
That's a major eye opener for senior management."
Braun-Davis, for her part, is closely watching the regulatory climate in Europe. The United Kingdom, for instance is looking
at revising its regulatory authority, the Medicines and Healthcare Products Regulatory Agency (MHRA), its FDA-equivalent.
"They're going to be creating a communications department, and they're looking for more enforcement from them in certain areas,"
Potentially more significant is a new move to aggressively combat healthcare fraud in Europe, earmarked by the newly formed
European Healthcare Fraud & Corruption Network. "They're going to have a 10-person staff based in Brussels," says Braun, "and
they're going to be sharing best practices among countries."
Marketing and Advertising
To the public, DTC advertising is the burning issue in the sales and marketing area. And the industry is hoping that the new
voluntary PhRMA DTC Code will be enough to satisfy Congress. "There are some among the CEOs of pharma companies that sit on
the PhRMA board that think it could have gone further," says Miles White, "and others who think it went plenty far enough.
At the end of the day, it will depend on how we behave as an industry. I'm optimistic."
Mason Tenaglia On Part D, In 2006, whenever anyone doesn't make their number, they're going to say, "It's Part D, we got
more dual eligibles than we thought." There's always going to be an explanation, and it's going to be about Medicare Part
D. It's going to happen at the earnings presentations; it's going to happen at all the sales reviews; it's going to happen
at the brand reviews. It could be the El Niño of 2006.
But the Senate Finance Committee, chaired by Senator Chuck Grassley (R-IA), is still poking actively into the pharmaceutical
industry—most recently into conflicts of interest in the clinical trials area. The second shoe has yet to drop on Grassley's
inquiry into marketing. "The question is what will the committee be doing?" says Bruce Bellande, executive director of the
Alliance for CME. "Will they be satisfied that things have improved and will continue to improve? Will they schedule hearings?
Will they decide there's enough there that they would want to craft legislation?"
For the moment, at least, it looks like FDA will do little on DTC beyond issuing a rising number of Notices of Violation.
What should it be doing? "Trying to address the question of what does DTC advertising want to be when it grows up. Any company that does
reminder ads in 2006 will be crucified and bring everybody else down with them."
It is clear that DTC has to evolve. "I think our DTC will be more DTP [direct-to-patient]," says Richard Nordstrom, CEO of
McCann Healthcare Worldwide. "We will focus more on the interaction between patient and physician, because there's a huge
gap there. We also need to build the CRM relationship with the patient. Clients are asking us to develop programs in tiny
markets with high value per patient, where it's imperative to talk to patients one on one. Not next year, but we will see
DTC, CRM, and professional marketing get much closer together."