By Kurt R. Karst – Last Friday, Representative Jason Chaffetz (R-UT) introduced H.R. 2985, the Combination Drug Development Incentive Act of 2013. The bill would amend the 5-year New Chemical Entity (“NCE”) exclusivity provisions of the FDC Act that affect the submission and approval of …
By Karla L. Palmer – The General Accountability Office (“GAO”) recently released its Report on Drug Compounding as Congress faces dueling compounding bills in the Senate (S. 959, Pharmaceutical Compounding Quality and Accountability Act, sponsored by Sen. Tom Harkin) and the House of Representatives ( H.R. …
The American Conference Institute (“ACI”) will be holding two events in the coming months that are of particular interest to FDA Law Blog readers. . . . and, importantly, for which our readers can get a discount. The first event is ACI’s Legal, Regulatory, and …
By Kurt R. Karst – Now that we've put the theme from The Jeffersons in your head . . . . On August 2, 2013, FDA will officially announce in a series of Federal Register notices the Fiscal Year 2014 (“FY 2014”) user fee rates under …
By Kurt R. Karst – A series of decisions handed down earlier this week by Judge Mary Jane Bowes of the Superior Court of Pennsylvania arising from mass tort litigation in Philadelphia County involving REGLAN (metoclopramide) and its generic versions can only be drescibed as …
By James E. Valentine* & Alexander J. Varond – Since the breakthrough therapy designation came into existence a year ago, drug companies (and their investors) have been trying to figure out the value of the program. The designation was initially proposed as a way to …
By Kurt R. Karst – FDA’s recent approval of Caraco Pharmaceutical Laboratories, Ltd.’s (“Caraco’s”) ANDA No. 077571 for a generic version of PRANDIN (repaglinide) Tablets is interesting on several fronts. For starters, it is the ANDA at the heart of the U.S. Supreme Court’s decision …
By Kurt R. Karst – In a unanimous decision handed down on July 23rd by a 3-judge panel of the U.S. Court of Appeals for the District of Columbia Circuit in Cook v. FDA (Case No. 12-5176), the Court largely affirmed a March 2012 decision …
By Kurt R. Karst – “… — …” – That’s the international Morse code distress signal commonly shown as SOS. SOS is also in the title of the acronymized “FDA SOS Act,” or the “FDA Safety Over Sequestration Act,” which a bipartisan group of members …
By Joseph W. Cormier – Last week, the Administrative Conference of the United States ("ACUS") made four recommendations to the Executive Branch and independent agencies, three of which may be of interest to readers of this blog. Among its first recommendations this year, the ACUS …
By James E. Valentine* & Anne K. Walsh – Despite Congress giving FDA new powers to regulate the integrity of the drug supply chain, the globalization of the pharmaceutical market continues to present clear challenges for the Food and Drug Administration (“FDA”). FDA’s new authorities …
By Kurt R. Karst – Touchdown! It was just last month that we posted on the first instance in which FDA resolved what has become known as a “180-day exclusivity punt.” As we explained then, “180-day exclusivity punts” are instances in which a first applicant eligible …
By Kurt R. Karst – You know the drill . . . . One organization comes out with a report saying one thing supported by various data. Days later, another organization comes out with a report saying another thing supported by other data. In what …
By Kurt R. Karst – Although the battle over the appropriate test to apply to drug patent settlement agreements (aka “reverse payment” or “pay-for-delay” settlement agreements) when evaluating whether or not they are immume from antitrust attack ended with the U.S. Supreme Court’s June 17th decision …
By Kurt R. Karst – Back in July 2010 we took a look at the historical growth of so-called “Patent Use Codes” (“PUCs”), those numbers and narratives listed in an Orange Book Addendum corresponding to a listed method-of-use patent. This was long before the U.S. …
