Pharmaceutical Law

Terra Sigillata

Category archives for Pharmaceutical Law

FDA and the New York Times are reporting today 23 cases of adverse reactions to various Hydroxycut weight loss supplements. (FDA Consumer PDF here). Above and beyond whether the stuff actually helps with weight loss, it is clear that the products contain some compound(s) that cause idiosyncratic cases of liver damage. According to the law…

Regular commenter and friend of Terra Sig, leigh (the path forward), let us know overnight that Florida State Veterinarian Dr Thomas J Holt officially confirmed that selenium overdose killed 21 Venezuelian polo horses in Wellington, Florida, on 19 April. An attempt by an Ocala, Florida, compounding pharmacy to reproduce an equine dietary supplement called Biodyl…

Last weekend, 21 Venezuelan polo horses collapsed and died at the US Open championship match at the International Polo Club Palm Beach in Wellington, Florida (AP, CNN). The deaths have now been associated with injection of a veterinary mineral supplement produced by a compounding pharmacy in Ocala, Florida. Located in central Florida about 45 min…

Back in February 2007, we had a lively discussion on a post about pharmacist objection to filling prescriptions for drugs they felt went again their personal moral stance: from morning-after pills to garden-variety oral contraceptives. I held that since pharmacists are licensed by the state to provide a service to the citizenry (and they make…

Blue Steel Hero

No, it’s not a song by Foreigner – these are the names of two products “promoted and sold over the Internet for the treatment of erectile dysfunction (ED) and for sexual enhancement.” In yet another instance of a trend that would be comical if not so serious, the US FDA has announced that “Blue Steel”…

Last week we spent some time discussing the shortcomings of the generic vs. brand name drug debate, focusing on an example of non-bioequivalence between the antidepressant Wellbutrin XL and its generic competitors. Three days later, I then received an e-mail from one John Procter about a movement to get Washington to move forward on the…

I wrote about the general issue of eyelash-enriching “cosmeceuticals” on my Terra Sigillata back in July. Increasing the number and thickness of eyelashes is not some hokey magical wish – it is a known side effect buried in the prescribing information for the prescription glaucoma drugs, bimatoprost (Lumigan®) and latanoprost (Xalatan®). Last Friday, the US…

Just one last comment on the recently passed FDA legislation. I know that Terra Sig readers must be tiring of this issue already, but this aspect was too good to pass up. I started writing this post on a lark but the topic actually has serious public health implications. John Mack at his Pharma Marketing…

The Pump Handle’s Liz Borowski put up a nice post summarizing the key points of the >400-page Food and Drug Administration Amendments Act of 2007 (H.R. 3580). Missing from the bill were any further restrictions on pharmaceutical direct-to-consumer (DTC) drug advertising – according to Liz, some drug safety advocates were calling for a complete ban…