By Wendy S. Salkin I. Our Bodies, Our Body Politic On March 30, at a town hall meeting in Green Bay, Wisconsin, an audience member asked then-presidential-hopeful Donald J. Trump: “[W]hat is your stance on women’s rights and their right to choose in their own reproductive health?” What followed was a lengthy back-and-forth with Chris Matthews….
By Jonathan Larsen, JD, MPP and Adrienne R. Ghorashi, Esq. The US Food and Drug Administration (FDA) approved the first biosimilar for use in the United States in March 2015. The approval came after several years of regulatory process development authorized by the Biologics Price Competition and Innovation (BPCI) Act of 2009, a component of…
By Diana R. H. Winters [Crossposted from the Health Affairs Blog] The Food and Drug Administration (FDA) has recently taken three steps toward providing consumers with more and better information about food products that the agency regulates. First, in response to several citizen petitions, the agency requested comments on the use of the term “natural” on…
By Dalia Deak A study published this week in JAMA examined how much physicians know about FDA approval standards for new drugs and the breakthrough therapy designation. The investigators found major gaps in understanding with regard to both issues, despite intuitive beliefs to the contrary. For the study, Kesselheim et al. conducted a national survey…
By Dalia Deak Fears of spreading zika virus have renewed interest in the use of genetically modified mosquitoes to suppress disease, with recent attention focused on the UK firm Oxitec. Last week, the developing public health crisis around zika prompted the federal government to tentatively clear a small-scale field test for the first time in…
By Dalia Deak The latest development in the race for approval between Jacobus Pharmaceutical Company and Catalyst Pharmaceuticals is a ‘refuse to file’ letter that the FDA issued to Catalyst indicating that Catalyst’s New Drug Application for Firdapse was incomplete. Both companies are competing for approval of slightly modified forms of a drug—3,4-diaminopyridine, or 3,4-DAP—…
By Timo Minssen As mentioned in my earlier blog post, I decided to conclude this year by publishing a introductory speech that I gave on April 14th, 2015 at the 2015 Broad Institute Innovation & Intellectual Property Symposium. The speech was part of the session “Bringing Therapies to the Patients” and introduced a panel-discussion with Entrepreneur and Professors of…
By Dalia Deak In the United States, though many millions of individuals live with implanted devices, it may shock you to know that it is easier to recall tainted dog food than it is to recall a faulty pacemaker. This is due in large part to the lag of the medical device world behind most other…
By Robert Field What adjective would most people associate with the word “bureaucrat”? For many, it would be “inefficient,” “inept,” or “incompetent.” But another that is just as descriptive is “lifesaving.” Dr. Frances Kelsey, who died this month at the age of 101, was celebrated as an American hero for her work as a medical…
By Diana R. H. Winters [cross-posted at Health Affairs Blog] On June 16, 2015, the Food and Drug Administration (FDA) released its final determination withdrawing the generally recognized as safe (GRAS) designation for partially hydrogenated oils (PHOs), which are the main source of artificial trans fat in processed foods. The agency gave the food industry…
