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 …
By Kurt R. Karst – Over the past week we’ve been inundated with new items concerning generic drug labeling and whether federal law – the FDC Act and FDA’s implementing regulations – preempts state-law product liability claims (failure-to-warn, design defect, failure-to-conform/update, etc.) against generic drug manufacturers. …
By James R. Phelps – George Miller Burditt died on March 13, 2013 following a heart attack. He was 90 years of age. With his passing the food and drug bar lost one of its most distinguished members. People were drawn to George by his friendly, …
By Alexander Varond – On March 12, 2013, FDA released a draft version of a revision to the February 2000 final guidance entitled “Formal Dispute Resolution: Appeals Above the Division Level.” We refer to the draft version as “Revision 1.” Revision 1 retains the original …
By Kurt R. Karst – Briefing is underway in K-V Pharmaceutical Company’s (“KV’s”) appeal of a September 2012 decision from the U.S. District Court for the District of Columbia that stymied the company’s efforts to “restore” orphan drug exclusivity for the pre-term birth drug MAKENA …
By Carmelina G. Allis – With information technology taking on an increasingly important role in the healthcare system, software app developers are focusing their efforts on developing programs intended to facilitate health, wellness, and disease management. Some of these apps are developed for and implemented …
