By Kurt R. Karst – Now that the shutdown of the U.S. Federal Government is over and FDA’s Dockets Management Branch is open again, the backlog of docket submissions is rolling in on regulations.gov, including Citizen Petiton responses issued during the shutdown. One petition response …
By Kurt R. Karst – FDA’s recent response to two Citizen Petitions (Docket Nos. FDA-2013-P-0995 and FDA-2011-P-0869) helped to shed some additional light on an issue that continues to vex companies considering submitting a 505(b)(2) NDA to FDA for a new drug: When do I …
By Kurt R. Karst – We’ve previously noted the resurgence of interest in (and controversy over) brand-side exclusivity. There’s the QI Program Supplemental Funding Act of 2008 (Pub. L. No. 110-379), which gave new life to “old” antibiotics. FDC Act § 505(u), titled “Certain Drugs …
By Riëtte van Laack – As previously reported, the American Meat Institute (“AMI”) and several international meat industry organizations filed a lawsuit in an effort to stop the Agricultural Marketing Service ("AMS") of the USDA from implementing the Country of Origin Labeling ("COOL") rule. On …
By Kurt R. Karst – On October 12th, California Governor Jerry Brown finally acted on Senate Bill 598, vetoing the measure. If enacted, the bill would have amended California’s Pharmacy Law to require, among other things, a pharmacy to notify a prescriber within 5 business days whether …
By Ricardo Carvajal – People have been eating insects for thousands of years, and the practice certainly has its devotees in the U.S. Notwithstanding that history of consumption, industrial production of insects for food use has remained a rarity. Now there are signs of a …
By Riëtte van Laack – In May of 2012, Plaintiff Matthew Dronkers filed a complaint in the United States District Court for the Southern District of California, on behalf of himself and other class members against Kiss My Face, LLC (“KMF”) claiming that KMF’s marketing …
By Kurt R. Karst – We were reminded earlier today that a new law has gone into effect in the state of Maine permiting the importation of drug products into the state from licensed retail pharmacies located in certain foreign countries. As we previously reported, …
By Jay W. Cormier – Notwithstanding the government shutdown, on Tuesday, October 1st, FDA’s Center for Devices and Radiological Health (“CDRH”) issued a final guidance regarding filing for an investigational device exemption (“IDE”) for medical device early feasibility studies. At the heart of the guidance is that …
By Kurt R. Karst – We’re now entering the second week of the shutdown of the federal government (or “the lapse period” as some have called it), and there does not appear to be an end in sight. In fact, the environment in Washington, D.C. has …
By Jeffrey K. Shapiro – There has been a lot of talk about hostage taking during the recent federal government budget impasse. But Congress is not the only one taking hostages in Washington. The recent draft Medical Device Reporting (MDR) guidance reminds us (pp. 4-5) …
Hyman, Phelps & McNamara, P.C. is pleased to announce that Kermit L. Jones, J.D., M.D. has joined the firm as an Associate. Prior to joining the firm, Dr. Jones served as a 2012-2013 White House Fellow assigned to the Secretary of Health and Human Services, …
By Riëtte van Laack & Ricardo Carvajal – On September 19, 2013, Cargill entered into a $5 million settlement agreement to dispose of a class action lawsuit regarding its advertising for Truvia® products as “natural.” Plaintiffs charged that the products are not natural because they …
By Jay Cormier & Alan Kirschenbaum – The Patient Protection and Affordable Care Act made extensive changes to the 340B drug discount program, which we have previously described. Among other things, the statute expanded the categories of covered entities entitled to purchase drugs at the …
By Kurt R. Karst – It was not a question of whether, but when FDA would issue its first Warning Letter to a facility covered by the Generic Drug User Fee Amendments of 2012 (“GDUFA”) that failed to self-identify its facility and pay applicable user fees. …
