By Kurt R. Karst – A rather interesting and unexpected (to most) ANDA approval popped up on FDA’s website late last week. On February 6, 2013, FDA approved Macleods Pharmaceuticals Limited’s (“Macleods’”) ANDA No. 202467 for a generic version of ACTOS (pioglitazone HCl) Tablets, 15 …
By Kurt R. Karst – Two recent citizen petitions submitted to FDA – one from Gilead Sciences, Inc. (“Gilead”) under Docket No. FDA-2013-P-0058, and another from Ferring Pharmaceuticals, Inc. (“Ferring”) under Docket No. FDA-2013-P-0119 – take issue with FDA’s long-standing position that in order for a …
On January 31, 2013, Hyman, Phelps & McNamara, P.C. presented a webinar addressing the real-world implications from the Second Circuit decision in United States v. Caronia. Panelists addressed the potential impacts to the pharmaceutical, devices, dietary supplements, and tobacco industries. HP&M was quite pleased that …
By Ricardo Carvajal – FDA announced a somewhat unusual consent decree for permanent injunction in which a manufacturer of fruit and juice products agreed to retain a labeling expert (among other experts) to ensure compliance with applicable FDA regulations. In part, the government alleged that the …
By Alan M. Kirschenbaum & Jennifer D. Newberger – Sixteen months past its statutory deadline, CMS issued last Friday a pre-publication version of its final regulation implementing the physician payment transparency provisions of the Patient Protection and Affordable Care Act. The rule is scheduled for publication in …
By Kurt R. Karst – As if on cue after our post yesterday concerning briefing in FTC v. Watson Pharmaceuticals, Inc. (Docket No. 12-416), where the U.S. Supreme Court will consider whether drug patent settlement agreements (aka “reverse payment agreements” or “pay-for-delay agreements”) are generally …
By Kurt R. Karst – Excitement is building (and will soon reach fever pitch) over the U.S. Supreme Court’s March 25, 2012 Oral Argument in Federal Trade Commission v. Watson Pharmaceuticals, Inc. (Docket No. 12-416) concerning whether drug patent settlement agreements (aka “reverse payment agreements” or …
By Kurt R. Karst – We don’t like loose ends – especially loose ends in the Hatch-Waxman world! Last June, we posted on FDA’s decisions to require sponsors of ANDAs for generic versions of ADDERALL XR (dextroamphetamine mixed salts of a single-entity amphetamine product) Extended-release …
By Ricardo Carvajal – FDA announced that it will host a series of public meetings on the recently issued proposed rules on preventive controls for human food and standards for produce safety. Fact sheets on the proposed rules are available here and here. The first meeting …
By JP Ellison – Earlier this month, the U.S. Sentencing Commission (the “Commission”) issued a Notice of Proposed Amendments to the U.S. Sentencing Guidelines, which are used by federal courts to determine sentences for criminal violations. The Notice contains several proposals that may be of interest …
By Delia A. Stubbs – Last Friday, January 25, 2012, after two days of discussion and deliberation, an FDA Advisory Committee voted 19 to 10 in favor of rescheduling combination hydrocodone from its current placement in Schedule III to Schedule II. The decision was informed by …
Hyman, Phelps & McNamara, P.C. ("HP&M") will hold a complimentary webinar on Thursday, January 31, 2013, from 12:00 – 2:00 PM (Eastern) on the Second Circuit's recent and long-awaited decision in United States v. Caronia. This webinar is not just another summary of the Second Circuit's decision. …
By Jennifer D. Newberger – On January 24, 2013, FDA finalized the Humanitarian Use Device (HUD) Designations guidance, issued in draft on December 13, 2011. The guidance addresses HUD requests, a first step in obtaining approval of a Humanitarian Device Exemption (HDE). A HUD is a …
By Ricardo Carvajal – Pharmacists Planning Service, Inc. ("PPSI"), a California-based “nonprofit public health, consumer, pharmacy education organization,” submitted a citizen petition asking FDA to make St. John’s Wort ("SJW") available only behind the counter. Specifically, the petition asks FDA “to remove sales of [SJW] …
By Karla L. Palmer – On January 22, 2013, the United States Court of Appeals for the District of Columbia Circuit dismissed a petition for review filed by several interest groups and individuals who petitioned DEA to initiate the federal rescheduling of marijuana. The case stems …
