Robinson Bradshaw

Month: August 2010

The Business Effects of Regulatory Uncertainty in Genetic Testing

The business of genetic testing has progressed rapidly, if unevenly, over the past several years. Like any business based on new and rapidly developing science, the promise of new products and markets is counter-balanced by the obstacles of developing commercial products from raw science, fostering markets for those products, constructing profitable business models and overcoming […]

The Cost of Regulating LDTs

Jeffrey N. Gibbs is a director at the law firm of Hyman, Phelps & McNamara and specializes in FDA-related matters. For many years, the Food and Drug Administration (FDA) has taken the position that while it has the authority to regulate laboratory-developed tests (LDTs) as devices, the agency would exercise its enforcement discretion and not […]

The Genomics and Personalized Medicine Act Returns to Congress

Meggan Bushee is a student at the Wake Forest University School of Law. This past May, Congressman Patrick Kennedy (D-RI) and Congresswoman Anna Eshoo (D-CA) re-introduced a personalized medicine bill to the U.S. House of Representatives. The bill was originally introduced in 2006 by then-Senator from Illinois Barack Obama. While HR 5440, also known as […]

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: The next step in nanopore […]

Swine Still Soaring: Federal Circuit Judge Expresses Sympathy for Myriad Analysis

Back in March, we headlined our discussion of the district court judgment in the Myriad case “Pigs Fly.” Guess what?—they’re still aloft. On August 4, in a highly technical patent case that, appropriately enough, involved “porcine virus DNA,” one Federal Circuit judge—dissenting Judge Timothy B. Dyk—suggested that he might agree with the basic principle of […]

Resolution in Florida Wrongful Birth Case

Tom Clarkson is a student at the University of Georgia School of Law. The “Wrongful Birth” debate is in the news yet again. In a pair of previous posts (here and here) the Genomics Law Report highlighted several issues relevant to the debate over what happens when states recognize a cause of action for wrongful […]

The Genomics Law Report is Hiring

As regular readers know, the Genomics Law Report is a publication of the law firm Robinson, Bradshaw & Hinson focusing on the legal implications of important developments in the fields of genomics and personalized medicine. Due to the increasing number of litigation, legislation, regulatory and policymaking activities in this field, one of the challenges for […]

The Past, Present and Future of DTC Genetic Testing Regulation

[Editor’s Note: Newsweek science editor Mary Carmichael has a DNA Dilemma. As Carmichael debates whether to take a direct-to-consumer (DTC) genetic test, she is soliciting feedback from the DTC community, from the public and from other commentators, including myself. At the end of the week, she will make her decision. On Tuesday, Carmichael and five […]