Prescription Drugs and Biologics

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. …

By Kurt R. Karst –       As you might imagine, we’re pretty avid FDA docket watchers.  As followers of this blog know, we track FDA petition decisions and regularly update our popular FDA Citizen Petition Tracker.  Keeping close tabs on FDA decisions and announcements posted on …

By Kurt R. Karst –       It’s a quiet news week here in the U.S. with the Independence Day holiday approaching.  But the news void has given us an opportunity to catch up on a few items we put on a backburner and intended to tackle …

By Alexander J. Varond – On June 25, FDA released a draft guidance entitled “Expedited Programs for Serious Conditions—Drugs and Biologics” and a related Manual of Policies and Procedures entitled “Review Designation Policy: Priority (P) and Standard (S).”   The draft guidance provides important insight into FDA’s …