by Jonathan J. Darrow Until recently, most ordinary people had never heard of “pharmacy compounding.” Then, a number of deaths and illnesses caused by a drug that was compounded in a Framingham, Massachusetts pharmacy propelled drug compounding to the national spotlight (see, e.g., Denise Grady et al., Scant Oversight of Drug Maker in Fatal Meningitis…
By Patrick O’Leary In the October 22 edition of The New Yorker, Michael Specter wrote a fascinating article about the growing and exciting science of the human microbiome, the ecosystem of ten thousand or so bacterial species that call each of our bodies home. The hype around this particular field of scientific and medical inquiry…
If you’ve been following the fungal meningitis outbreak and wondering about the legal implications, take a listen to this audio interview with Glenn Cohen and personal injury lawyer Michael F. Barrett, hosted by Legal Talk Network’s Lawyer2Lawyer. They discuss the litigation likely to stem from this outbreak (and some already pending), as well as the role…
By Jennifer S. Bard I’m sure many of us are talking about the contaminated steroid injections which have spread a fungal form of meningitis Exserohilum rostratum across the country. The CDC, which as is usually the case is doing an excellent job of providing clear and current information, reports that as of “October 17, 2012,…
by Jonathan J. Darrow On October 3, 2012, the FDA’s Division of Professional Drug Promotion issued an untitled letter to Genentech in connection with its cancer drug Tarceva. Tarceva (erlotinib) was approved in 2004 for the treatment of non-small cell lung cancer, and has since been approved, in combination with Gemzar (gemcitabine), for the treatment…
By Arthur Caplan In his latest MSNBC column, Art Caplan addresses a different angle of the fungal meningitis outbreak: Many needlessly getting steroid injections for back pain, bioethicist says The quest for relief from pain has now resulted in the deaths of 19 people and a total of 247 confirmed infections of fungal meningitis from…
By I. Glenn Cohen Over at Jotwell, Michael Carroll (American) has a very nice review of a new paper that is a collaboration between two of our former fellows at the Petrie-Flom Center, Michael Frakes (Cornell) and Melissa Wasserman (Illinois). Their article is Does Agency Funding Affect Decisionmaking?: An Empirical Assessment of the PTO’s Granting…
By Patrick O’Leary A friend and I were having a conversation about health policy the other day when he observed that drug regulators like FDA face an impossible task in terms of public expectations: as consumers, we expect the drugs we take to be 100% safe, 100% of the time. Of course, no regulator, no…
We are pleased to announce plans for our annual conference, this year entitled: “The Food and Drug Administration in the 21st Century.” This one and a half day event will take place Friday and Saturday, May 3-4, 2013, at Harvard Law School in Cambridge, Massachusetts. For details on the event and the call for proposals,…
By Laura Stark Fifty years ago on Wednesday, President Kennedy signed into law the US Food and Drug Amendments. The amendments radically overhauled the way in which manufacturers brought drugs to market. Most importantly, the amendments instituted the four-phase review process and the requirement that manufacturers get informed consent from people receiving experimental drugs. If…
