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“This conference is timely," Mark McClellan began, “because opportunities are increasing in regulation across the board.” Regulation has recently become the subject of much focus, with innovative new tools and avenues continually evolving. Healthcare is no different. McClellan, the former Administrator of the Centers for Medicare and Medicaid, and the former Commissioner of the Food and Drug Administration, opened the Mossavar-Rahmani Center for Business & Government's 25th Anniversary conference on New Directions in Regulatory Policy.
McClellan focused on the challenges and benefits of new trends in healthcare regulation. In the wake of recent scandals requiring the removal of a drug from the shelves after its consumption by millions, blockbuster drugs like Vioxx have been on the minds of legislators. However, McClellan emphasized, the public’s frustration is not that drugs sometimes have adverse side-effects but that the FDA is not doing a good enough job following up and monitoring risks associated with new drugs. Regulatory agencies like the FDA are criticized by all sides for their action or, sometimes, inaction. But “Knowing this can be liberating," he reflected," and you can just focus on doing your job without trying to please everyone.”
McClellan argued that the central problem with healthcare regulation is ratio between investment and productivity. Currently, high amounts of investment often correspond with a low amounts of productivity, or return on that investment. Annual investment in new drugs exceeds $100 billion but little of that translates into benefits for patients and new products. For instance, nanotechnology is being heavily invested in, but the only viable product to come from it so far is a sunscreen. Furthermore, the average success rate of new products has been decreasing, and currently stands at a disappointing 20% despite a 10-15 year product development timeframe and billions of dollars in R&D. As a result, only fifteen new drugs are approved each year. From an innovation standpoint, McClellan sees this as disturbing.
He underscored this trend reflecting on the challenges of Alzheimer’s - a substantial public burden, with considerable investment, but little to show for it. “We still don’t understand Alzheimer’s very well”, he said. "There are no good biomarkers for it. There are certainly many proposed biomarkers but no proof that those markers are valid predictors." Significant work is still needed before ‘new’ sciences like genomics can translate into medical breakthroughs on the ground for patients.
Healthcare is at a crossroads. Science is advancing while the regulatory structures built to deal with it are stalled, becoming increasingly inadequate. McClellan called for a new regulatory framework encompasing science-based pathways for new products, ideally reducing the time needed to bring them to market. He sees public-private-academic partnerships as a key way to accomplish this, easing the methods for acumulating data on population use of a new drug. "With something like this, Vioxx could have been discontinued in five months not five years", McClellan asserted.
Encouragingly, a recent effort to reform the FDA’s post-market processes passed through Congress in a surprisingly bipartisan manner, showing just how much Congress is willing to move on this issue.
The Q&A session featured a focus on international issues. Responding to a question about the increasing globalization of healthcare, McClellan pointed out that medical tourism remains a very small fraction of total healthcare. Eventually, the level of globalization in healthcare will be determined by evidence of what works best and where. In response to a question regarding the U.S.'s stringent standards for stem cell resesarch, McClellan argued that too many practical challenges remain for such research. The many technical issues involved with stem cell research must first be sorted out before a dialogue on ethics and competition is undertaken.
Audience members raised technical questions regarding the challenges of using biomarkers. "There is a potentially unlimited array of biomarkers but no coherent science to help prioritize them," McClellan noted, "and this is where an effective public-private partnership, with a role played by academia, could be critical. Right now, all this talk of markers makes for good journal articles but we are still a long way away from practical use of biomarkers."
A Harvard College sophomore inquired about the implications of increased surveillance of new drugs’ performance on people’s privacy. McClellan feels reassured that the level of surveillance will only be go as far as the public feels comfortable with. Most likely, he thinks the focus will be on aggregate data rather than individual records, though aggregation is a far more challenging approach operationally.
McClellan’s address emphasized that although we are at the dawn of a new era in regulation, much work remains before healthcare can realize the potential of these new approaches to regulation.
-Roshan Paul
MPP2
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