By Kurt R. Karst & Frank J. Sasinowski – The Orphan Drug Act (“ODA”), which President Ronald Reagan signed into law on January 4, 1983, turned 30 years old in January. The milestone came just days after the death of actor Jack Klugman, who has been …
By Riëtte van Laack – On February 11, FDA issued its response to a December 2009 citizen petition (Docket No. FDA-2009-P-0587-0013) requesting that FDA issue an order confirming that certain prescription prenatal vitamins containing 1-4 mg folic acid, either alone or in combination with other vitamins …
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 …
