big pharma & mobile tech: navigating the fda
DESCRIPTION
Medical & Health initiatives led the way in 2013 at SXSW. But what were missing were Big Pharma and the FDA.The FDA 3 years ago promised guidance on Pharma social practices and 2 years ago promised guidance on Pharma mobile health apps and medical devices. They released preliminary guidance, had a public forum, but never made good on their promise. In the mean time Pharma companies have been trying to couple their drugs with actionable care solutions. The gray area is around patient tracker apps. The original guidance said “anything that helps the doctor make a treatment decision is a medical device”, but the community said, “hold it, how is that different from a paper and pen journal?” The FDA responded at an open forum, yet they never released guidance. So,many pharma companies are afraid of getting a letter. Our discussion will focus on what we can do to improve the submission and approval process of medical apps and devices through the FDA.TRANSCRIPT
Naviga&ng the Uncertain Waters of the FDA Big Pharma & Mobile Tech
Meet the Presenters:
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Timothy Makoid
User Experience InnovaFon Lead
Benjamin Weisman
SVP Director of CreaFve InnovaFons
1. Why should we trust big Pharma? 2. What’s holding up innovaFon? 3. What’s the deal with the FDA? 4. What can we do about it?
Our Presenta&on Will Cover:
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Why should we trust Big Pharma?
• Pharma owes you one… and they’ve got the money
• They’ve got great talent
• They’re one of the most knowledgeable resources in the world on diseases and treatments and they have their finger on the pulse of the medical and HCP communi&es
• They have endless amounts of pa&ent and HCP data and they know their customer well
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What’s Holding Up InnovaFon?
Actually it’s happening all the &me behind the scenes but a large por&on of well designed mobile health technology never sees the light of day because of
MLR and the FDA.
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What’s MLR:
Medical/Legal/Regulatory Every pharma company has a team of lawyers that review anything released by the company to insure that they don’t release anything that will get them in trouble with the FDA.
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So what’s the deal with the FDA?
ANer 3 years of promising guidance on Pharma social and mobile prac&ces, we’re s&ll leN wondering what we are and aren’t allowed to do.
Because of this a lot of MLR reviewers are afraid to proceed without clear guidance.
This accounts for millions of dollars of lost ini&a&ves that could be going towards helping pa&ents deal with their condi&on and treatment and helping HCPs educate and socially communicate with each other and their pa&ents.
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So what can we do about any of this? • We need to keep this conversaFon going. RegulaFon is important, and
that’s why we need the FDA to provide us with some. We’re not asking for free reign, just guidelines so we can start innovaFng.
• Speaking of innovaFng, keep doing it. The more health tech that hits the market, the less likely Pharma can deny itself an opportunity to join the movement. And the more money spent on health tech, the beXer.
• Communicate with the FDA. Let them know that we want guidance now and that they’re holding up innovaFon in America.
So if you’d like us to talk about any of these issues please vote for us for SXSW InteracFve 2014. Thanks!
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