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Entering the 21st century…precisely?
February 2015
by Jeffrey Bouley  |  Email the author
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So, we recently saw Congress attempt to enter the current century in terms of healthcare when the House Energy and Commerce Committee released a legislative discussion draft as part of its 21st Century Cures initiative. Better late than never? Probably that’s the pessimistic corner of my mind talking; rather than see the glass 85 years full, I see it 15 years empty.
 
Granted, there are some good things in that House discussion draft. As business and policy analyst firm Avalere notes, one important aspect for many of you could be a proposal “to expand the Food and Drug Administration’s Patient-Focused Drug Development initiative, including through greater use of patient-reported outcomes as part of the FDA review process. These provisions could be notable in advancing greater patient engagement throughout a product’s life.”
 
Also, the National Organization for Rare Diseases wrote: “The discussion paper issued by the House Energy and Commerce Committee on January 27 contains a number of ideas on how to advance the development of new medical therapies.  A few provisions apply specifically to rare diseases, including adding six months to the patent life of orphan drugs.”
 
Other notables from draft include talk of better use of surrogate endpoints, expanded access to investigative treatments, streamlined clinical trials, support for continued innovation at federal health agencies and modernization of drug and device regulation.
 
It wasn’t long after this legislative discussion draft emerged that President Barack Obama had his own things to say about healthcare when he gave the State of the Union speech. For his part, rather than have an expansive set of issues and goals—not that such a move is better or worse, mind you; just different—he focused in on personalized medicine when he announced a program called the Precision Medicine Initiative. In his speech before Congress and the rest of the nation, Obama said, “Twenty-first century businesses will rely on American science, technology, research and development. I want the country that eliminated polio and mapped the human genome to lead a new era of medicine—one that delivers the right treatment at the right time."
 
It’s a good idea, given how important personalized medicine is set to become in healthcare, though Leerink Partners analysts noted, “The President’s FY2016 budget proposal will only include $215 million for the Precision Medicine Initiative, a relatively small number in context of a $30-billion NIH budget, in our view. Most of the money, $130 million, is earmarked for the creation of a one-million-person volunteer cohort.”
 
Bottom line: I’m of the “wait and see” attitude. Both Congress and Obama are saying important things and both have their eyes—finally—on the current century. But this is also a government that has managed to inadequately fund the National Institutes of Health, the Food and Drug Administration and so many others critical to the health of our nation—for longer than the decade I’ve worked on this magazine.

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