Most of the entries here at the MDD Perspectives blog address med tech, but I’m going to go off topic and address the compounding pharmacy issue, because it is at risk of becoming an FDA issue. As we all know, the New England Compounding Pharmacy (NECP) is said to be the source of the tainted methylprednisolone injections that led to the multiple cases of meningitis, and now the predictable cry has gone out to have FDA regulate compounding pharmacies. The idea is understandable, but let’s find out what’s...

Trekkies and non-Trekkies alike will recognize the expression “resistance is futile” as a favored saying among the drones of the Borg collective of Star Trek fame. Obviously I’m paraphrasing with the title of this essay, but let’s ask ourselves a question: Is it a big deal that the Department of Health and Human Services still does not have an agreed-upon standard for electronic health record (EHR) interoperability? HHS has been yakking about this since 2005, when Mike Leavitt ran the department. Now we have Kathleen Sebelius and still no...

BOSTON – The last day of AdvaMed 2012 included a discussion of the case of Prometheus v. Mayo that left observers with little reason for optimism unless the observer was employed by a large commercial entity with a good budget for legal consultation. Otherwise, holders and would-be holders of intellectual property might find the outcome of Prometheus leaves them ill equipped to manage patents and patent portfolios in a way that steers around some of the issues that arose in the case, which is expected to not only reshape the contours of the patent landscape going forward, but could eviscerate a number of existing patents as well.

BOSTON — The second day of AdvaMed 2012, hosted by the Advanced Medical Technology Association (AdvaMed; Washington), included a session dealing with the recent guidance for responding to unsolicited inquiries into off-label indications, and many in attendance may have hoped for a promise from FDA that it would fill in the blanks in the December 2011 guidance on this subject.