This makes for a more complex environment for pharmaceutical communicators. They no longer exercise complete control over what is and is not made public. The challenge is to shape—rather than create—a drug's safety and efficacy profile. To do that, pharmaceutical public relations executives must develop expertise in putting masses of data into perspective, rather than just promoting selective and largely positive data.

TRANSITION 3 The largely uninhibited marketing environment is replaced by one in which the profits from overly aggressive marketing are punishable by disgorgement of profits and even punitive fines.

Until recently, the main inhibition on overly aggressive or off-label promotion was FDA, whose punishment came in the form of a warning letter—a minor slap on the wrist that many marketers treated as a badge of honor.

TRANSITION 4 There will be a switch from the current marketplace, with modest pricing constraints, to one in which the government will inevitably play a central role.

A year from now, the prescription drug benefit under Medicare kicks in. While the Bush Administration has pledged no price controls, the reality is that they are inevitable. The federal government simply cannot afford to pay "retail" prices when billions of dollars can be saved by negotiating lower prices.

When that occurs, private insurers will demand the same prices. How many drugs are so absolutely unique and beneficial that a company can set its own price?

Coupled with this will be the need for companies to demonstrate, as never before, that their new drugs are truly worth their prices. The Medicare reimbursement program will lead to shifts in how diseases are treated, away from using the latest and more expensive therapies, to using older and less expensive products. To protect their markets, companies will be forced to demonstrate, through well-controlled studies, that the more expensive drugs are really better.

So what do these transitions add up to? Fundamental changes in how the pharma industry does business. And in the center of the change will be the marketing communications and PR teams.

They will have to market drugs in a time of newly imposed and highly visible marketing constraints. Press releases that tout a new drug's potential or a marketed drug's possible new uses will be viewed in a prism of skepticism and concern. DTC advertising that merely promotes a product rather than educates about a disease will be examined more carefully. Communications efforts that focus on benefits to the exclusion of drug safety will no longer be acceptable.

The public is more sensitized. Companies will find that audiences are more skeptical, hardened by the lessons of the last year, and more demanding of medical and cost justifications.

Moreover, healthcare communicators will be functioning in an environment in which any misstatements are subject to scrutiny not just by FDA, but by US Attorney offices looking for new cases, by company whistle-blowers who are paid a percentage of whatever is recovered in fines, by product liability lawyers searching for new evidence, and by a Medicare program and private insurers intent on keeping costs down.

Finally, these transitions occur in an industry that has never achieved a public image worthy of its contributions to public health advances. Its pricing policies and profit margins have controlled its image. There is no reservoir of positive feelings among key constituencies to draw upon.

This is the challenge that communicators face as the industry enters a time of change, and most particularly a new era of constraint and scrutiny.

Bob Chandler, Yun-hee Lee, Gianfranco Chicco

Launches The Washington, DC office of Chandler Chicco Agency (CCA), expanded by the acquisition of Ignition Strategic Communications, will be run by current CCA DC office head, Jeff Nesbit. CCA also formed a joint venture with Macoll, an independent healthcare public relations agency in Korea. » Eli Lilly ran full-page ads in newspapers nationwide to respond to allegations in the British Medical Journal about confidential documents on Prozac. » Fleishman-Hillard and Provisio forged a patient recruitment partnership.

People The American Epilepsy Society named nursing professor Joan Kessner Austin as president. » Jack Huttner was appointed chairman of the New York Biotechnology Association.

Wayne L. Pines formerly with FDA, is a consultant on regulatory and media issues. He can be reached at wpines@apcoworldwide.com
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