By Kurt R. Karst – In a decision handed down on September 30, 2013 (but not unsealed until last Friday), the U.S. District Court for the District of Columbia rebuffed a challenge by Cumberland Pharmaceuticals Inc. (“Cumberland”) to FDA’s approval of a generic version of Cumberland’s acetaminophen …
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 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 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 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 Ricardo Carvajal & Kurt R. Karst – According to contingency plans drawn up by the Department of Health and Human Services, 45% of FDA’s nearly 15,000 staff were to be furloughed in the absence of enacted annual appropriations – popularly referred to as a …
By William T. Koustas & Jessica A. Ritsick – With California’s electronic pedigree requirement set to take effect in 2015, we have been following recent efforts by Congress to enact a national prescription drug track and trace system (see our previous posts here, here, here, …
By William T. Koustas – We have previously reported (here and here for example) on the litigation between Regenerative Sciences, LLC (“Regenerative”) and FDA. Regenerative is a Colorado company that owns a medical procedure known as the Regenexx Procedure. It is a non-surgical procedure by …
By Kurt R. Karst – Anyone from the United States who has visited a foreign city – like São Paulo, Brazil or Mumbai, India – knows immediately upon exiting the sealed environment of their aircraft that they are no longer in the United States. There’s …
By Kurt R. Karst – FDA’s latest Report to Congress, required by FDC Act § 505(q)(3), on the Agency’s experience with so-called “505(q) citizen petitions” during Fiscal Year 2012 (“FY2012”) is largely a rehash of the FY2011 Report to Congress (see our previous post here on …
By Kurt R. Karst – The titles – and sometimes even the content – of some of our posts are inspired by the things we experience (or have experienced) in our regular, non-attorney lives. For years now we’ve weaved together with food and drug law …
By Delia A. Stubbs – As previously reported, the Physicians for Responsible Opioid Prescribing (“PROP”) filed a Citizen Petition in March requesting that FDA limit the labeling of “controlled release” opioids to severe-only pain in non-cancer patients. The petition also requested that FDA impose certain …
By Kurt R. Karst – In the 1992 movie A Few Good Men, military lawyer Lt. Daniel Kaffee (played by Tom Cruise) handles the court martial of two U.S. Marines charged with the murder of a fellow Marine. The Marines contend they were acting under …
