Monday Morning Recap: The Week in Drug & Device Law & Policy

Filed in Monday Morning Recap by on December 23, 2013 0 Comments

Picture3What follows is a weekly feature here at Health Reform Watch.  Each Monday morning, we provide a recap of the drug and device law and policy developments over the previous week that caught our eye and made us think.  Credit for the format goes to Seton Hall Law alum Jordan T. Cohen, who used it to great effect in his series of Reform Rodeo posts.

1. Last week brought the big news that GlaxoSmithKline will stop paying doctors to promote its drugs, stop paying for doctors to attend medical conferences, and stop paying sales reps on a per prescription basis.  Ed Silverman at Pharmalot characterizes the changes as GSK’s “latest bid to restore its damaged reputation”; Christopher Robertson at Bill of Health calls the company’s announcement “cause for hope”, noting  that the “needle does move.”

2. In JAMA, Harold Sox measures the new guidelines on managing high blood pressure against standards promulgated by the Institute of Medicine in 2011.  As Sox notes, “[a] rigorous, transparent process for developing and reviewing guidelines matters a great deal because guidelines are increasingly driving the practice of medicine.”

3. In the latest article in ProPublica’s series “The Prescribers”, Tracy Weber and Charles Ornstein address Medicare Part D fraud.  Weber and Ornstein write: “When criminals plunder Part D, justice is rarely swift. Investigators from so many agencies are involved that chasing down fraud often seems like a relay race in which someone fumbles the baton—or stops well short of the finish line.”

4. Also on the topic of enforcement, I highly recommend Judge Jed Rakoff’s essay in the New York Review of Books entitled “The Financial Crisis: Why Have No High-Level Executives Been Prosecuted?”, the implications of which extend beyond the financial crisis, including to the prosecution of healthcare fraud.  Judge Rakoff writes that the recent trend of prosecuting companies in favor of the people who work at companies is “technically and morally suspect. It is technically suspect because, under the law, you should not indict or threaten to indict a company unless you can prove beyond a reasonable doubt that some managerial agent of the company committed the alleged crime; and if you can prove that, why not indict the manager? And from a moral standpoint, punishing a company and its many innocent employees and shareholders for the crimes committed by some unprosecuted individuals seems contrary to elementary notions of moral responsibility.”

5. Finally, at The Atlantic, Mark Micheli comments on the effect of the budget deal on the National Institutes of Health, noting that the agency “lost $1.71 billion during sequestration and has seen a 25 percent reduction in overall funding since 2003. … The budget calls for an increase in discretionary spending to $1.012 trillion in FY14 and $1.014 trillion in FY15. At the NIH, that’s equivalent to potentially reducing the sequester cuts for 2014 by half and the cuts for 2015 by a quarter, according to Science magazine. But for now, the precise effect on NIH awaits the decision of the Appropriations committees, which are to decide specific funding allocations by January 15.  It’s a step in the right direction, research advocates say, but still far from enough.”

This will be our only post this holiday week.  See you next Monday!

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