That's easier said than done. With its own approval rating in the tank, Big Pharma will have to raise its voice over the campaign roar about the high price of drugs. "As the candidates get nominated," says DrugWonks blogger Peter Pitts, "the rhetoric will expand, and there will be fewer and fewer specific policies and more and more applause lines."

In fact, it's the insurance industry's high price of coverage and low level of reimbursement that is taking most of the heat. Even a New York Times lead editorial allowed that the cost of prescription drugs was a red herring in the public debate. A national healthcare "conversation" next year could conceivably popularize this fact—and begin to shift the burden of public animosity to the third-party payers.

"The payers are where the action is," says Bruckner Group's Russo. "They have completely overturned expectations by insisting to both consumers and pharma that saying no is now a very big part of the system."

Even the hot-button issue of drug pricing could be turned to pharma's advantage, according to Murray Aitken. "The cost of daily drug consumption fell last year between 20 and 35 percent in the top-five therapeutic areas," he says. A campaign publicizing this fact could undercut campaign rhetoric about the high cost of drugs.

Up on The Hill

Beltway insider and Arnold & Porter Pharmaceutical Division Head Daniel Kracov says that once a new administration takes over, the rhetoric gets toned down in the interest of actually getting the problem solved. "That's when the industry, as an important constituency, traditionally takes a seat at the policymaking table," Kracov says. "But pharma has been so marginalized by Congress and the media over the past few years that I wonder if it will get a seat."

Yet with a raft of legislation on such critical issues as patent reform, biosimilars, and comparative studies already afloat in Congress, the industry needs to speak with a loud voice now more than ever.

The consensus on follow-on biologics is when, not if. According to Murray Aitken, "when" is several years out—especially given FDA's recent rejection of Momenta's generic Lovenox. His advice: "Watch how biosimilars play out this year in Britain and Germany as generic EPO is marketed. How will it be detailed? Will doctors use it?"

On the comparative-effectiveness front, Kracov predicts that pressure from third-party payers will raise both funding and visibility for government-run studies and "pay for performance." Although currently delinked from Medicare coverage decisions, he says, "payers will start demanding the right to apply the information. And if the whole initiative becomes payer-driven, they could influence the outcome of the studies." If pharma wants to protect the integrity of its brands, it needs to get out in front of the issue.

Merck and Schering-Plough, however, are getting pharma's outcomes-trial credibility off to a spectacularly bad start. After hemming and hawing about the long-postponed release of outcomes data from the companies' study of blockbuster cholesterol-buster Zetia, Congress smelled a possible cover-up. An investigation—and ugly headlines—will likely greet the new year.