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 Reg. 13629 (Mar. 14, 2011); FDA, Draft Guidance for Industry, …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 …
By Kurt R. Karst – Each year, thousands – indeed, tens of thousands – of pages are written concerning the Hatch-Waxman Amendments. As we were clearing out our in-box this past weekend, we came across two scholarly articles from some Hatch-Waxman “regulars” that we think merit …
By Jennifer B. Davis – Three and a half years ago, Congress directed FDA to identify lower risk devices for reporting malfunction MDRs on a quarterly basis in summary form. FDA still has not done so. Specifically, the Food and Drug Administration Amendments Act of 2007 (“FDAAA”), …
By Peter M. Jaensch & John R. Fleder – On January 18, 2011, the President issued a significant Order entitled a “Memorandum for the Heads of Executive Departments and Agencies.” The Memorandum directs “agencies with broad regulatory compliance and administrative enforcement responsibilities” to, within 120 days, …
By Ricardo Carvajal - In an upcoming issue of the Federal Register, FDA is announcing a public meeting scheduled for March 29 to solicit comment on the import safety provisions of the Food Safety Modernization Act ("FSMA"). At the meeting, appropriately titled “Food Safety Modernization Act; …
By Susan J. Matthees – The USDA’s Economic Research Service (“ERS”) recently published an article titled “Will Calorie Labeling in Restaurants Make a Difference?” that considers the potential impact of the new menu labeling requirements for chain restaurants. As we previously reported (here and here), § 4205 …
By Kurt R. Karst – In what is, to our knowledge, the first instance in which a company has asserted the patent delisting counterclaim provisions added by the Medicare Modernization Act (“MMA”) in the context of a 505(b)(2) application – and even in the context of …
By Kurt R. Karst – On March 7th, the U.S. Supreme Court denied yet another Petition for Writ of Certiorari concerning whether patent settlement agreements (what opponents call “pay-for-delay” agreements or “reverse payments”) are unlawful and violate the antitrust laws. As we previously reported, the case, …
By William T. Koustas – We have previously reported on the long running legal battle between the Federal Trade Commission (“FTC”) and the American Bar Association (“ABA”) over the implementation of the FTC’s Red Flags Rule (“the Rule”). Last Friday, the United States Court of Appeals …
