By Katie Hayes, Content Writer, Product Marketing Life Sciences

We're just a few weeks away from Model N's 14th annual Rainmaker conference, hosted this year in Carlsbad, California, and the team has been working hard to ensure that attendees will learn about new product updates from our experts, understand the evolution of business models, and become revenue management digital strategy leaders. Read the full agenda here.

Our keynote session last year, 'The Great Debate,' featured the perspectives of Senator Tom Coburn and Governor Howard Dean in an effort to understand how global businesses may be impacted amidst impending legislature changes. The debate was moderated by John Shakow, partner at King & Spalding, and covered multiple topics that even nine months later, are top-of-mind for Life Sciences and High Tech manufacturers. Here are a few highlights of 'The Great Debate,' and you can look forward to learning about the 2018 regulatory outlook from John Shakow at this year's event.

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Shakow: Why is it, that although pharmaceuticals are 10% of the total healthcare spend, the pharma industry is so demonized? Are there reasons you see in the political, media, and pharmaceutical manufacturing community as to why they bear such a brunt of the demonization?

Governor Dean: The pharmaceutical industry is a convenient whipping boy for the press. You can't have a discussion without talking about Shkreli because the press always takes the most outrageous cases and puts them forward. Corporations aren't well-respected these days in America. The people don't trust government, but they don't trust corporations either. The pharmaceutical industry saves money, but it's an uphill climb.

Senator Coburn: What we have is a regulatory environment that is not effective or efficient at bringing new products to market and have raised the cost where it's almost prohibitive. Pharmaceutical CEOs aren't a whole lot different than any other CEO, but they catch a whole lot more pain for the good that they do.

Shakow: Let's talk about the FDA. Both of you have written about the FDA and the ways in which you might reform it. Senator, you in fact promoted a patient's FDA act before you left the Senate and you talked about the impact of bioinformatics-which is a term I think the audience would like to hear a little more about. Governor, you've talked about the need for what you called, 'unprecedented collaboration' between industry, government, and patient advocacy and academic research communities, in order to find breakthrough medicines. Can you talk, for just a few minutes about how each of you sees FDA reform, both in the near and long-term?

Senator Coburn: Bureaucracies can never do what's best when they can do what's safe. The issue is especially true with the FDA, whether you have a medical device that you want to make one small change to-it may take two or three years before approval. Or if you have a drug that's absolutely going to be approved but the FDA is going to slow-walk it because they're not absolutely sure. What we have is this play-out of control of the future of people's lives because a drug that should have been approved three years ago is still sitting in some FDA department.

Governor Dean: I think the FDA has been vilified, in some cases fairly, because it's a bureaucracy and I do think it's changing. There's a lot of good stuff going on that we don't talk about. For example, people yell and carry on about how the federal government creates drugs and research opportunities while the pharmaceutical industry profits from it. Well, that actually isn't true. We all focus on what's going wrong, when there's a lot more going right.

Shakow: Let's not forget that both the ACA and healthcare reform involved both the federal and state governments. A lot of responsibility was put on the states in order to effectuate pieces of the ACA, and as we saw in the Supreme Court, states were given some latitude as to which parts they were going to adopt and which they were going to leave aside. Senator, an article in the NYT implies that the actions of the state of Oklahoma have contributed in part to the problems that these folks are feeling. Did Oklahoma make bad choices?

Senator Coburn: No, Oklahoma didn't make bad choices. We have a problem with healthcare in our country. We spend 40-45% more than what we should be spending and a good portion of it are wasted. It's not actually helping anybody get well and it's not preventing them from getting sick. We're now seeing how overpriced healthcare is and how unresponsive it is to the innovation and new thoughts that can come about to lower the cost of healthcare.

Specifically, the January 2017 Organisation for Economic Co-operation and Development (OECD) report cites that 20% of the total health expenditure in the U.S. is wasted. The report also notes that one in ten patients experience adverse outcomes due to treatment, resulting in 10% of a hospital's expenditure to be spent on correcting that outcome.

Governor Dean: I agree that costs are too high in healthcare, but I don't agree that the consumer can drive down the costs considerably. We have an insane system. If a group of people who are delivering care have a fixed budget, they should be able to decide whether they should invest early in wellness rather than waiting until everybody gets sick-because that's how they get paid. Price transparency is a good thing, I support it, but I just don't think it's going to make much of a difference at the high end, and that's where all the money gets spent.

Senator Coburn: The assumption, in 80% of our economy, is that we know how to make good decisions, and if we don't, we pay more for it or we don't get value-one or the other. Is healthcare really that much different? The vast majority of money that we spend in healthcare is on people extending their life who don't have an extendable life, and that's a problem.

What are your thoughts on 'The Great Debate'? Leave a comment below or email them to khayes@modeln.com.

Have you confirmed your spot at Rainmaker 2018 yet? Make sure to look over the updated agenda, which now includes both a technical and a user track.

Model N Inc. published this content on 11 January 2018 and is solely responsible for the information contained herein.
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