How many times did you hear the words “historic realignment” over the course of this election cycle? How many times did you hear it when President Obama was elected two years ago? How many times when the Democrats took control of Congress four years ago? We can safely assume that, when it comes to “historic realignment,” the phrase has been overused and largely rhetorical–unless you are a fan of the Miami Heat.

But that doesn’t mean the mid-terms are unimportant or unlikely to deliver some real healthcare-related fireworks. When it comes to healthcare reform and a 21st century U.S. Food and Drug Administration, will the 112th Congress be sanguine or sanguinary? Or is there a third way of bi-partisanship?

The impact to healthcare reform is complicated, but some things are clear. For one, high profile members such as California Democrat Henry Waxman (Energy and Commerce), Connecticut Democrat Rosa DeLauro (Agriculture and FDA Appropriations) and California Democrat Pete Stark (Ways and Means) will be moving over to the minority side of the dais. Their inability to set the agenda is a game changer when it comes to healthcare reform and the future of the FDA.

Considering the role that healthcare reform played in the midterms, we can expect a series of hearings on the many aspects of the Patient Protection and Affordable Care Act. Many of these will center on the contentious philosophical notion of a cost-centric design versus a patient-centric system. That means hearings featuring the recess-appointed Center for Medicare & Medicaid Administrator Don Berwick. Berwick, an on-the-record fan of a cost-effectiveness-based, single-payer system will face some intense grilling.

There could be other hearings as well ranging from the surprising healthcare role of the Office of Personnel Management, which is planning a new database that will store healthcare claims information from three federal programs, to the Independent Payment Advisory Board, which can make dramatic changes to Medicare plans, including raising premiums, cutting benefits, and restricting eligibility requirements.

The repercussions of the mid-term elections aren’t only on the national front. With more governors and state legislatures likely to take strident positions on the issue of mandatory insurance coverage, the altered national agenda will also take on a local flavor. Nowhere will this manifest itself more than on another foundational issue of the legislation–state insurance exchanges. As state officials implement their plans, Congressional hearings will focus on how to design exchanges so they don’t crowd out free market insurance mechanisms.

A Republican House will also be important to the future of the FDA. At the top of the list are hearings on reauthorization of the Prescription Drug User Fee Act set to expire in 2012. PDUFA allows the FDA to collect fees from the industry to fund the review of new drugs. With Republicans in charge, PDUFA debate will focus not only on what FDA wants, but what the agency committed to previously and hasn’t delivered, such as enhanced predictability.

House hearings on PDUFA V will focus not only on the details, but also on the spirit of user fees, which could result in a cleaner reauthorization. That would be a trifecta victory for the FDA, industry, and public health. It would also be a strong message for all involved that PDUFA needs to get back to first principles.

With Representative Rosa DeLauro in the minority, her plan to direct the FDA to create an independent Center for Post-Market Drug, Device and Biologics Safety and Effectiveness (via a rider to the appropriations bill) is dead on arrival. This strengthens the hand of FDA Commissioner Peggy Hamburg, who has argued for the need to strengthen the integration of safety and efficacy throughout the lifecycle of medical products.

What about the FDA’s Critical Path initiative and the Reagan/Udall Center? New hearings are in order to get this crucial FDA initiative out of the state of suspended animation that DeLauro exiled it to since its inception. In her perplexing efforts to impede the work of the Reagan/Udall Critical Path Foundation, DeLauro has demonstrated a remarkable lack of understanding of the science of drug development and the purpose of the Critical Path.

Hearings may also be forthcoming on safety and manufacturing standards for both generic drugs and follow-on biologics. Good manufacturing practices are the silent sisters of post-market safety.

The seemingly endless ritual of House hearings on FDA’s role in direct-to-consumer advertising is likely to shift its focus from how to stop it to how to improve it. A hearing on how pharmaceutical marketing can be both savvy marketing tactic and potent public health tool that would take the vitriol out of the debate and help to create a powerful communications partnership between regulator and regulated.

Will the 112th Congress usher in a new spirit of bi-partisanship on healthcare reform and a 21st century FDA? That’s the difference between a hearing aid and a hearing problem. That’s the difference between addressing policy concerns and playing politics.

Winners and losers aside, we’ve got an opportunity to work together on healthcare, FDA and a plethora of other issues. Or we can all go down with the (partisan)ship. It’s time for pragmatism.

Peter J. Pitts, a former FDA Associate Commissioner, is president of the Center for Medicine in the Public Interest.