Robinson Bradshaw

Month: March 2011

The FDA and DTC: Time to Set the Record Straight

Earlier this month an FDA advisory panel met for two days to consider a range of issues pertaining to clinical direct-to-consumer (DTC) genetic testing. The non-voting advisory panel’s discussion (pdf), including whether certain genetic tests or categories of tests should be made available only through qualified healthcare professionals, sparked considerable controversy (see here for a […]

Frustrated by NIH Inaction, Fabry Patients Attempt End Run Around Bayh-Dole

Back on January 18, 2010, we reported on the National Institutes of Health’s (NIH) refusal to exercise the government’s “march-in” rights under the Bayh-Dole Act with respect to the patent-protected drug Fabrazyme (agalsidase beta). The drug is an enzyme replacement produced from a recombinant mammalian cell line (i.e., a biologic) and is used to treat […]

Twitter Roundup: FDA DTC Edition (and a new format)

Beginning this week, we are unveiling a new format for the Genomics Law Report’s regular Twitter Roundup. In addition to cataloging Dan’s @genomicslawyer tweets, we will also be offering short summaries of several key developments pulled from those tweets which, for one reason or another, did not find their way into a full-length post. Think […]

Closer Scrutiny Ahead for DTC Genetic Testing Claims

The FDA’s public meeting on the future of clinical direct-to-consumer (DTC) genetic testing (which we have covered here, here and here) is continuing to draw significant attention from the media and other commentators. Most of the coverage, especially over the past 7-10 days, has added little that is new in the way of either reporting or analysis. One […]

Considering the Impact of Yet Another Proposal for Genetic Legislation

Last month we examined Massachusetts’ proposed Genetic Bill of Rights. Last week, we looked at a similar proposal to expand individuals’ property and privacy rights in genetic information proposed in the Vermont legislature. Today, we head west to California to examine another piece of recently introduced genetic legislation. A New Padilla Proposal. The California proposal […]

Is the Genetic Rights Movement Picking Up Steam?

The movement to confer greater legal protection to individuals’ genetic information has added another participant. Last month, we examined newly introduced legislation in Massachusetts which, if passed, would create a “Genetic Bill of Rights,” significantly expanding Massachusetts residents’ personal property and privacy rights in their genetic information. Since then, in what the Council for Responsible […]

The FDA and DTC Genetic Testing: Setting the Record Straight

Earlier this week, I attended a public two-day meeting of the FDA’s Molecular and Clinical Genetics Panel (“MCGP”) in Gaithersburg, MD.  The meeting was not particularly well attended (approximately 100 people were in the room) but the topic of the panel’s deliberations – how to appropriately regulate direct-to-consumer (DTC) genetic tests – has sparked intense […]

Looking Ahead After the FDA’s DTC Meeting

Day one of the FDA’s two-day public meeting on the future of clinical DTC genetic testing is in the books. Those unable to attend in person were, unfortunately, forced to resort to Twitter coverage of the proceedings as the government declined to provide a live webcast. (I’m told there will not be a recorded webcast […]

Clearing a Path for DTC Oversight

In a few hours, the FDA will kick off a two-day public meeting to consider the future of clinical direct-to-consumer (DTC) genetic tests. Few corners of the personal genomics landscape have generated as much attention from regulators, consumers and, especially, the media as DTC genetic testing. Thus, when the meeting was first announced last month, […]

Twitter Roundup

With so many developments at the intersection of genomics and the law, there are often a variety of interesting stories that, for one reason or another, don’t find their way into a full-length posting on the Genomics Law Report. Here is a recap of what I was Tweeting recently @genomicslawyer: RT @wilbanks: As an aside, […]