Last week, the excruciatingly long and unpredictable path of health care reform passed another milestone when President Obama held a summit at Blair House among leaders in Congress to try to forge out a bipartisan approach to a bill that would reform health care. In the end, little changed. Democrats pushed for progress while Republicans were intransigent in their determination not to allow the proposed legislation to become law. It was a minuet of sorts – elegant, but not terribly substantive when it came to progress, but interesting to watch. And, at the end of the day, one might have recalled the classic line uttered by the character Bob Berrenger (played by Alec Baldwin) in the film State and Main after his character emerged from an upside down station wagon he had just rolled – "So – that happened."
What it did accomplish was to open a pathway for the Administration to drive the legislation independent of Republican opposition through the reconciliation process. The event, for the Administration, did accomplish one thing – it proved that there was no other way to proceed because a bipartisan effort, despite best efforts, was not possible. And now the machinery is in motion to bring attempt passage through the reconciliation process, which is estimated to take a matter of weeks. Of course, it was also estimated that this would be done last summer. Then it was estimated it would be done for the State of the Union….
In any case, if health care reform as it is now perceived does become law, how will it affect FDA and the pharmaceutical industry? Considering that the primary effect of the bill is that 31 million or so Americans who did not have any health care insurance coverage prior to the bill will now have it. That access will bring many changes not only to their individual lives, but systemically as well.
The most obvious impact on FDA? It would seem that the increased access to physicians is going to also probably mean increased access to treatments – i.e., drugs, biologics and devices. That, in turn, means that not only will people increase their use of medical treatments, but very likely the span of medical treatments will increase as well. Undoubtedly many of the poorest uninsured will enter the system of care with multiple diagnoses. And many will be screened at new levels, catching diseases and conditions much earlier in their cycle – before their manifestation in symptoms. That means people that never got screened, for example, for HIV infection, may now discover that infection early before the onset of illnesses as a result of a compromised immune system and when they can intervene with life-saving drugs.
With that increased access to treatment AND to treatments will come an increase in scale for adverse events. FDA and industry have a job ahead of them to educate a very large number of people who may be lacking the savvy of the healthcare elite in this country, to spot and report adverse events.
It is time for FDA to think and to begin to anticipate and act now, before all of those people enter the system. The agency must ask itself – what are the issues they are going to be facing as an essentially "treatment naive" population, particularly with regard to adverse event reporting. And how are we going to advise and instruct them? Should it come from the agency? Should the agency be planning support for health care providers?
One thing is certain. The answer won't be in hoping that people come to the labyrinth FDA Website and miraculously stumble on information that will help them. It will mean going out to where people are and taking the information to them. And to not prepare these folks for a new level of engagement with the healthcare system in general, and with medical treatments in particular, would be the equivalent of rolling the station wagon and saying – "So – that happened." Except that this time, it wouldn't be funny.
