By Delia A. Stubbs – As previously reported, Congress recently introduced the Stop Oxy Abuse Act that would restrict the labeled indications for use of any controlled release drug containing Oxycodone-Hydrochloride (HCl) to “severe-only” versus current labeling of “moderate-to-severe” pain. The legislation is similar to a recent …
By Kurt R. Karst – A recent Complaint filed in the U.S. District Court for the Southern District of Florida by Accord Healthcare, Inc. and Intas Pharmaceuticals, Ltd. (collectively, “Accord Healthcare”) against Acorda Therapeutics Inc. (“Acorda”) and H.D. Smith Wholesale Drug Co. (“H.D. Smith”) is the …
By Ricardo Carvajal – When FDA published its proposed rule on preventive controls as authorized by FSMA, we noted that FDA requested comment on a number of important issues that were not addressed in the text of the regulation itself, namely product testing, environmental monitoring, and …
By Kurt R. Karst – Despite amendments to the statute, court decisions, and FDA interpretations, there has been one constant throughout the nearly 29-year history of the Hatch-Waxman Amendments: dates matter. If a company – or FDA – misses a deadline by just one day, …
By Kurt R. Karst – A recent per curiam decision from the U.S. Court of Appeals for the District of Columbia Circuit may be the last word in litigation Hill Dermaceuticals, Inc. (“Hill”) initiated in November 2011 against FDA, as Hill filed a petition for …
By Delia A. Stubbs & Alan M. Kirschenbaum – Yesterday the OIG issued a Special Fraud Alert on physician owned distributorships, or PODs. The OIG describes these entities as “physician owned entities that derive revenue from selling, or arranging for the sale of, implantable medical …
Somewhat later than anticipated, the Federal Trade Commission (“FTC”) has published a revised version of its guide, .Com Disclosures. The FTC released the original guide 13 years ago, when mobile phones had not yet met the internet and social media barely existed. In the new version …
By Riëtte van Laack – On March 18, 2013, the Government Accountability Office ("GAO") released a report addressing FDA’s use of Adverse Event Reports ("AERs") in overseeing dietary supplements. Specifically, GAO examined (1) the number and source and the types of dietary supplements identified in adverse …
By Delia A. Stubbs – On Thursday, March 21, 2013, Representatives Harold “Hal” Rogers (R. Ky.), who is the co-founder and co-chairman of the Congressional Caucus on Prescription Drug Abuse, and Stephen Lynch (D. Mass) introduced the Stop Oxy Act of 2013 (H.R. 1366). The legislation seeks …
By Jeffrey K. Shapiro – The U.S. Court of Appeals for the D.C. Circuit (appeal no. 11-1268) issued a decision last Friday backing up FDA’s denial of 510(k) clearance to two of Cytori’s products, the Celution 700 and the StemSource 900, which are intended to harvest …
By Kurt R. Karst – Excitement is running high in the pharmacetical world with just hours to go before the U.S. Supreme Court hears oral argument on Monday, March 25, 2013 in Federal Trade Commission v. Actavis (Docket No. 12-416) concerning whether drug patent settlement …
By Karla L. Palmer – Senators Joe Manchin (D-W.Va.) and Mark Kirk (R-IL), along with Representatives Vern Buchanan (R-FL) and Edward Markey (D-MA) introduced on March 20, 2012 bipartisan, bicameral legislation to combat prescription drug abuse by attempting to tighten restrictions on what they characterize …
By Etan J. Yeshua – New York City's portion cap rule will have its day in court (again) in early June. The rule, which would have fined food service establishments for each sugary drink sold in a container larger than 16 ounces, was challenged and struck …
By Kurt R. Karst – Earlier this week, the U.S. Court of Appeals for the Second Circuit issued a decision that paves the way for the Natural Resources Defense Council (“NRDC”) to pursue its action to compel FDA to finalize the Agency’s review and regulation …
By Riëtte van Laack – As we previously reported in January 2013, the Federal Trade Commission (“FTC”) determined that POM Wonderful, LLC’s advertising for its products violated the FTC Act and issued a cease and desist order restraining POM’s future advertising. On March 8, 2013, POM filed …
