Almost from the beginning of primary season, we were told that the state of our national healthcare system would figure large in this presidential election cycle.
Rising healthcare costs, the number of uninsured and underinsured, affordability of insurance, the Medicare reforms, the cost of prescription drugs, the re-importation of prescription drugs from Canada - all were said to be hot-button issues.
But up until the recent debates, there was far more talk about health concerns as a campaign issue than there had been about the concerns themselves. In the Cheney-Edwards face-off and the final Sen. Kerry-President Bush clash, both sides agreed that our present healthcare system is broken - where they differ is on how to fix it.
Bush and Cheney described the Medicare drug plan as "the most important and significant change in healthcare in the last several years" and promised to protect Americans' "freedom of choice" in selecting physicians, as well as to provide tax credits for healthcare expenditures. Kerry and Edwards promised that their administration would not side with the drug and insurance companies, and would bring down the cost of healthcare by providing access to congressional health plans, allowing the importation of drugs from Canada and negotiating drug prices on the Medicare formulary.
Whether or not healthcare will play a major role in the last few days of the campaign, these issues are receiving a great deal of attention inside the Beltway. And it's clear from what's being said that the outcome of the election will have an enormous impact on pharma companies.
Sources tell us that if President Bush is re-elected and Republicans maintain control of the Senate, Big Pharma is going to launch a major initiative, perhaps offering to establish a multibillion-dollar fund for patients harmed by FDA-approved drugs in return for a bulletproof shield from state lawsuits. And there seems little doubt that if Kerry is elected, a push for universal access to healthcare will dominate the health policy discussion early - as it dominated the first term of the Clinton Administration.
If Bush is re-elected, we can also expect a major electronic medical records initiative. We'd also look for further amendments to the Medicare Act, more movement on the FDA's Critical Path initiative, and changes in post-marketing surveillance requirements. Insiders along the Capitol Hill-Rockville axis also are speculating that a Bush re-election would bring with it the appointment of a Big Pharma veteran to the critical post of FDA commissioner.
DC insiders also are predicting that if Sen. Kerry wins, we could see former FDA Commissioner David Kessler at the helm of HHS. Along with his appointment, we'd expect to see major battles over DTC advertising, tightening of restrictions on ties between NIH-funded researchers and pharmaceutical companies, restructuring of the FDA Office of Drug Safety, and a host of other initiatives that will be viewed as anti-Pharma.
The industry's natural reaction to a Kerry election would be to dig in for a four- or eight-year holding action. Just as the natural reaction to a Bush victory would be for the industry to call in its substantial chits in order to make whatever gains it can quickly, solidifying its current positions.
But both of these courses of action ultimately would be disastrous for two simple reasons.
First, virtually everyone now agrees that the healthcare system is broken and needs a major overhaul. Whether that overhaul occurs during the first four years of a Kerry administration, or the next time the Democrats control Congress, it will happen. And second, the pharma industry has already been unfairly cast as a villain in the ongoing healthcare drama, and throwing its weight around following a Bush victory would only make recasting that reputation more difficult.
So, from a long-term point of view, whatever happens at the polls on November 2 should be viewed, and acted upon, by the industry as a turning point - a chance to reinvent itself as a consumer-friendly healthcare player. Some of the best and brightest health economists and healthcare policy experts work for the major pharma companies. The industry needs to seize a leadership role in the healthcare-reform debate by offering up its expertise around issues that will not be seen as pharmacentric, areas in which the industry can be seen as providing new ideas, rather than hardening old positions.
For the pharma industry, the future is now. Spending the next four years concentrating more on providing the kind of healthcare reforms consumers seek might mean taking some short- term hits in terms of accepting legislation that is hard to swallow. But swallowing a few bitter pills now will go a long way toward changing public attitudes toward the industry, and, in turn, strengthening the industry's reputation and bargaining position for years to come.