By Nisha P. Shah & Alan M. Kirschenbaum – In an unusual step, the State of California’s Department of Insurance intervened in a qui tam lawsuit brought against Bristol-Myers Squibb (“BMS”) by three former employees, including a former member of the L.A. Lakers. In The People …
By JP Ellison – The criminal prosecution of Lauren Stevens, the former in-house counsel for GSK, took another twist yesterday when Judge Titus dismissed her indictment without prejudice. We have previously reported on this prosecution here and here. Judge Titus found that the prosecutors' explanation to …
Have you been looking for that one, comprehensive publication that covers intellectual property and patent law issues in the pharmaceutical, biotechnology and chemical industries from around the world’s key jurisdictions? Well, it’s finally here – or will be in the next month or so when …
By Ricardo Carvajal – The Supreme Court affirmed a 9th Circuit Court of Appeals decision that allows a securities fraud class action to go forward against Matrixx Initiatives, Inc. ("Matrixx") for allegedly violating § 10(b) of the Securities Exchange Act and Exchange Commission Rule 10b-5. As …
By Ricardo Carvajal – Last week FDA published a Q&A that explains steps the agency is taking to ensure that foods imported from Japan are safe. Currently FDA does not believe there is any risk to the U.S. food supply, but is continuing to gather information …
By Larry K. Houck – Early March on Capitol Hill has seen a flurry of legislation designed to combat a number of perceived controlled substance problems, including opioid treatment, pain management, drugs marketed to kids and pill mills. Prescription Drug Abuse Prevention and Treatment Act of 2011 Senator …
Hyman, Phelps & McNamara, P.C. (“HP&M”) and VirginiaTech are pleased to announce the availability of the first two DVD’s of the VERSUS series that is being sponsored by VirginiaTech. They provide an overview of the processes a prescription drug must follow to be FDA-approved and …
By Kurt R. Karst – Last week, Senator Robert Casey (D-PA), along with co-sponsors Sens. Scott Brown (R-MA), Sherrod Brown (D-OH), Al Franken (D-MN), and Johnny Isakson (R-GA), formally introduced S. 606, the Creating Hope Act of 2011. The bill, which, according to Sen. Casey “has …
By Michelle L. Butler & Kurt R. Karst – FDA recently published in the Federal Register notice of a long-awaited revision to its draft interim guidance on user fee waivers, reductions, and refunds. See 76 Fed. Reg. 13629 (Mar. 14, 2011); FDA, Draft Guidance for Industry, …
By Riëtte van Laack – On March 4, 2011, FDA issued a warning letter to Goetze’s Candy Co. Inc., because the addition of calcium to Goetze’s Caramel Cream Chocolate goes against FDA’s food fortification policy, 21 C.F.R. § 104.20. Goetze marketed its product with the (impermissible) …
By Jennifer D. Newberger – One of the tasks of the Office of Inspector General (“OIG”) of the Department of Health and Human Services (“HHS”) is to make recommendations that will result in cost savings and/or improvements in program efficiency and effectiveness. Unfortunately, as we are …
By Kurt R. Karst – Last week, Judge Richard Leon of the U.S. District Court for the District of Columbia granted FDA’s Motion to Dismiss a lawsuit filed in April 2010 by a group of ear candle advocates after the Agency issued about 15 Warning Letters …
Hyman, Phelps & McNamara, P.C. is pleased to announce that Diane B. McColl has been elected to serve as the new Vice President of the International Society of Regulatory Toxicology and Pharmacology (“ISRTP”). ISRTP’s mission is to provide an open public forum for policy makers …
By Susan J. Matthees – A new development in the ongoing battle involving sodium thiopental, one of the drugs used for lethal injections, surfaced today when the Drug Enforcement Administration (“DEA”) seized Georgia’s supply of the drug. According to the Atlanta Journal-Constitution, a DEA spokesperson confirmed …
By Nisha P. Shah – Effective March 28, 2011, sponsors and investigators of human drug and biological products subject to either an investigational new drug application ("IND") or bioavailability ("BA") or bioequivalence ("BE") studies exempt from IND requirements will have revised safety reporting requirements under the …
