By Kurt R. Karst – Nearly seven years after having received a citizen petition (FDA Docket No. FDA-2005-P-0120) requesting that FDA apply more stringent and unconventional bioequivalence requirements (and twice supplemented – here and here – along the way) before approving generic versions of ADDERALL XR …
By Kurt R. Karst – We’re always interested in cases where things, at first glance, just don’t seem to add up. If we cannot find an explanation, we may put the case to the side for a while, and wait until an explanation becomes available. That’s …
By Kurt R. Karst – Over the past year or so, we’ve seen a change in FDA policy concerning what approvals the sponsor of a 505(b)(2) NDA can cite in an application; that is, what previous FDA approvals a 505(b)(2) sponsor can rely on for the …
By Kurt R. Karst – A new article, titled “Citizen Petitions: An Empirical Study,” analyzes citizen petitions submitted to FDA between 2001 and 2010 and concludes that petitions submitted to FDA concerning drug products are on the rise and show no signs of abating. The paper, …
By Anne Marie Murphy & Benjamin K. Wolf* – On June 12, 2012, FDA announced the availability of a draft guidance, titled “Considerations When Transferring Clinical Investigation Oversight to Another IRB” (“FDA Draft Guidance”). This is the first time FDA has provided through guidance specific direction …
By Kurt R. Karst – In a move that brings to mind Scene 2 of Monty Python and the Holy Grail, in which a mortician roams the streets ringing a bell and calling out “Bring out your dead!” (a close second being the Monty Python “Dead …
By Kurt R. Karst – As the U.S. Senate and U.S. House of Representatives geared up last month to consider bills in their respective chambers to, among other things, reauthorize and amend old and establish new user fee statutes, one FTC Commissioner – Commissioner J. Thomas …
By Kurt R. Karst – After a round of congratulatory speeches, the U.S. House of Representatives passed H.R. 5651, the FDA Reform Act of 2012, as amended, on May 30th by a vote of 387-5. Unlike the U.S. Senate, which passed its version of the bill …
By Kurt R. Karst – In a recent, 95-page decision from the U.S. District Court for the Eastern District of Pennsylvania in In re Wellbutrin XL Antitrust Litigation, the court once again tackled the issues of “sham” citizen petitions, liability under the Sherman Antitrust Act, and …
By Kurt R. Karst – We’re not economists, but we’re interested in the topic insofar as it concerns Congress’ consideration of FDA-related legislation, such as H.R. 5651, the FDA Reform Act of 2012, which is on tap for consideration by the U.S. House of Representatives later …
By Kurt R. Karst – After days of debate and a slew of proposed amendments, the U.S. Senate passed S. 3187, the FDA Safety and Innovation Act, on Thursday afternoon by a roll call vote of 96-1. Senator Bernie Sanders (I-VT), who cast the lone vote against passage, …
By Kurt R. Karst – FDA’s recent approval of ANDAs for generic versions of sanofi-aventis’ (“sanofi’s”) blockbuster blood thinner drug PLAVIX (clopidogrel bisulfate) Tablets (approved under NDA No. 020839) upon the May 17, 2012 expiration of a period of pediatric exclusivity associated with Orange Book-listed U.S. Patent …
By Michelle L. Butler – Abbott Laboratories (“Abbott”) recently submitted a citizen petition to FDA regarding biosimilars under the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”). Specifically, the citizen petition requests that FDA not accept for filing, file, approve, or discuss with any company …
By Kurt R. Karst – A lot has happened since we last updated our Generic Drug Labeling Carve-Out Citizen Petition Scorecard in October 2011. At that time, AstraZeneca had only recently submitted two citizen petitions concerning quetiapine fumarate (SEROQUEL and SEROQUEL XR). Petitions, FDA decisions, lawsuits, …
By Kurt R. Karst – Two new reports were published this week analyzing FDA’s performance under the Prescription Drug User Fee Act (“PDUFA”). The reports – one from the California Health Institute (“CHI”) and The Boston Consulting Group (“BCG’), and another from the Tufts Center for …
