By Alexander J. Varond – In response to FDA’s increasing reliance on Risk Evaluation and Mitigation Strategies (“REMS”) for the management of risks presented by certain drugs, the US Department of Health and Human Service’s Office of Inspector General (“OIG”) conducted an investigation into FDA’s …
By Jessica A. Ritsick – This week, the Institute of Medicine (“IOM”) released its report, commissioned by the FDA, “Countering the Problem of Falsified and Substandard Drugs.” The objective was to gain an understanding of the “global public health implications of falsified, substandard, and counterfeit …
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 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 Kurt R. Karst – Last week, Actelion Pharmaceuticals Ltd. and Actelion Clinical Research, Inc. (collectively “Actelion”) filed what might be the company’s last motion in its preemptive lawsuit filed last September in the U.S. District Court for the District of New Jersey seeking declaratory …
By Kurt R. Karst – Late last year, FDA submitted to Congress the Agency’s latest report on FDC Act § 505(q) citizen petitions. The report, titled “Fourth Annual Report on Delays in Approvals of Applications Related to Citizen Petitions and Petitions For Stay of Agency …
By Kurt R. Karst – Although FDA has yet to accept an application for a biosimilar version of a biological product licensed under the Public Health Service Act (“PHS Act”) pursuant to the provisions of the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”) …
By Kurt R. Karst – The Federal Trade Commission (“FTC”) has announced the release of its annual summary of agreements (a.k.a. “drug patent settlement agreements,” “reverse payment agreements” or “pay-for-delay agreements”) filed with the Commission during the last fiscal year (Fiscal Year 2012): “Agreements Filed …
By Kurt R. Karst – In a notice that will be published in the January 17th Federal Register, FDA announces the establishment of Fiscal Year 2013 (“FY2013”) user fee rates established pursuant to the Generic Drug User Fee Amendments of 2012 (“GDUFA”) for both Active Pharmaceutical …
By Alexander J. Varond – FDA announced earlier this week that it will hold a public hearing to obtain input on a potential new pathway to expedite the development of drugs and biological products for serious or life-threatening conditions that would address an unmet medical …
