Kim Kardashian recently trumpeted the beneficial effects of Diclegis, a pill indicated for the treatment of nausea and vomiting of pregnancy for certain women, to her over 42 million Instagram followers. One such Kardashian devotee apparently works at the U.S. Food and Drug Administration (FDA), which sent a …
If You Think You’re Safe from FDA Scrutiny Because You’re in an Ivory Tower, Think Again
March 19, 2015 Leave a Comment
There is no “cloak of invisibility” for researchers. FDA increases enforcement based on clinical research violations. According to recently-posted data, 2014 was a banner year for FDA enforcement based on clinical research violations. The Center for Drug Evaluation and Research (CDER) Office of …
There’s No Such Thing as Bad Publicity
March 9, 2015 Leave a Comment
As of March 3, Solvay Pharmaceuticals is ready to second P.T. Barnum’s famous dictum that there’s no such thing as bad publicity. That’s the day a federal court in Texas dismissed a qui tam action against Solvay. The whistleblowers filed suit in June 2003, claiming that Solvay paid kickbacks to …
What’s an MDDS? And Why Should I Care?
July 31, 2014 Leave a Comment
Last month the Food & Drug Administration (FDA) announced still further relaxation of its oversight over anything qualifying as a “medical device data system,” or MDDS. The announcement should come as welcome news to a great many hospitals and physicians. In its June 30 “Draft Guidance for Industry …
Good News for Hospitals: FDA Eases Up on Medical Device Data Systems
June 20, 2014 Leave a Comment
A couple of years ago, FDA reclassified Medical Device Data Systems from a Class III product requiring premarket approval, to a Class I, 510(k) exempt product. Now the agency says that it doesn’t intend to enforce even the general controls applicable to Class I products. In a guidance document issued today, …
OPDP Did Not “Like” That Post—Untitled Letter Follows
March 19, 2014 Leave a Comment
Recently FDA’s Office of Prescription Drug Promotion (OPDP) published an untitled letter issued to Institut Biochimique SA for this Facebook post. As can be seen from the screenshot, the claim made in the post omitted safety information as well as statements of material fact (the approved indications). While …