Pharmaceutical Law

Terra Sigillata

Category archives for Pharmaceutical Law

In our last post, we discussed a recent USPTO ruling that rejected a claim of the Pfizer patent on the erectile dysfunction drug, sildenafil (Viagra®), to a novel oral treatment for the disorder. The patent appeals panel ruled that the existence of horny goat weed, a traditional Chinese medicine used orally for impotence, was grounds…

Reuters and Bloomberg reported earlier this week on an ongoing patent battle (read: pissing match) between Pfizer and Eli Lilly & Co. relating to their erectile dysfunction drugs Viagra and Cialis, respectively. A US Patent and Trademark Office (USPTO) appeals committee has ruled that an element of Pfizer’s patent on sildenafil, the active chemical in…

It seems that bodybuilding supplement makers are challenging erectile dysfunction supplement makers to see who can recall the greatest number of products adulterated with undeclared, unapproved drugs. In this case, an internet retailer of the following supplements has issued a voluntary recall of the following supplements sold between June 1, 2009 and November 17, 2009.…

In an article by Wayne Heilman of the Colorado Springs Gazette, I learned of a US FDA action against contract drug manufacturer Provident Pharmaceuticals. The company has been cited for good manufacturing practices (GMP) violations as well as the manufacture of unapproved drugs. The GMP violations are of a magnitude that FDA requested that Provident…

By most metrics, those of us at Terra Sig World Headquarters are liberals. Nevertheless, we often enjoy reading conservative writer, attorney, and American Enterprise Institute fellow, David Frum. Perhaps I have a soft spot for him because he’s Canadian and he also writes for my favorite print newsmagazine, The Week. Well, Frum chose this week…

In September we posted “M.D. Anderson name misused in Evolv nutraceutical water advertising,” detailing the not-exactly-truthful claim by a multilevel marketing company that their bottled water product was “tested” by one of North America’s premier teaching and research hospitals. A flurry of search engine hits to this post raised my attention to the fact that…

I should probably create a new blogpost category just for erectile dysfunction dietary supplements adulterated with authentic or synthetic analogs of prescription phosphodiesterase-5 (PDE5) inhibitors (e.g., Viagra, Cialis). However, FDA has already created a page for this earlier this year after dozens of companies have been identified as putting real drugs into their erectile dysfunction…

Rebecca Skloot, journalist, University of Memphis writing professor, and author of the upcoming book, The Immortal Life of Henrietta Lacks (pre-order here), just brought to my attention this commentary by Dr Pieter Cohen in the New England Journal of Medicine entitled, “American Roulette — Contaminated Dietary Supplements.” In the commentary, Dr Cohen remarks upon the…

We’ve spoken here every few months about so-called natural dietary supplements being adulterated with prescription drugs used for similar indications. The most common of these of late have been erectile dysfunction supplements which have been repeatedly found to contain the active compounds present in prescription E.D. products such as Viagra and Cialis. The latest public…

Salvia divinorum (Salvia, Magic Mint) is a plant used for entheogenic purposes by the Mazatec people of Mexico. A relative of the common garden plant “scarlet sage” (Salvia splendens), S. divinorum contains several hallucinogens that include salvinorin A, the first non-nitrogenous agonist known for kappa opioid receptors (KOR). I had known of salvinorin A since…