By Anne K. Walsh – Most news involving the False Claims Act reports that a company paid large sums of money to the government and relators to settle allegations of off-label promotion. Not so in this post about a recent decision dismissing a relator’s complaint. Not …
By Kurt R. Karst – We’ve said it before, and we’ll say it again: 180-day generic drug marketing exclusivity governed by the version of the FDC Act in effect prior to the December 2003 enactment of the Medicare Modernization Act (“MMA”) is alive and kicking. . …
By Kurt R. Karst – Earlier this week, FDA issued its highly anticipated (well, at least for this blogger) Consolidated Response to two Citizen Petitions (Docket Nos. FDA-2013-P-1397 and FDA-2013-P-0884) submitted to the Agency last year by Eisai Inc. (“Eisai”) and UCB, Inc. (“UCB”) arguing that …
By Jamie K. Wolszon – Earlier this month, FDA’s Center for Devices and Radiological Health (“CDRH”) announced a new voluntary “expedited access premarket approval (“PMA”) program” intended to speed development and approval of devices that treat or diagnose a life-threatening or debilitating disease and fulfill an …
Hyman, Phelps & McNamara, P.C. (“HP&M”) is happy to announce that six of the firm’s attorneys have been named “Super Lawyers” in the Washington, D.C. area in the 2014 Washington DC Super Lawyers Magazine. Super Lawyers is a rating service of outstanding lawyers from more …
By Ricardo Carvajal – FDA issued a final rule that prohibits nutrient content claims for the omega-3 fatty acids DHA and EPA, as well as certain nutrient content claims for ALA. The final rule carries through on the proposed rule issued in November 2007 with no …
By David B. Clissold – Under the Family Smoking Prevention and Tobacco Control Act (“Tobacco Control Act”), the Food and Drug Administration (“FDA”) was given the authority to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. Other “tobacco products” could be regulated by FDA only …
By Kurt R. Karst – FDA’s recent denial of a November 2009 Citizen Petition (Docket No. FDA-2009-P-0566) submitted by the American Dental Association (“ADA”) requesting that the Agency “review and establish an appropriate regulatory classification” for the safe use of peroxide-containing tooth whiteners that lighten tooth …
By Wes Siegner – Dan Fabricant has now left FDA. In his short tenure as FDA division head and spokesperson on dietary supplement matters, the agency devoted more resources to dietary supplement enforcement matters. Moreover, the industry was routinely criticized for failing to file new …
By Kurt R. Karst – The battle over New Chemical Entity (“NCE”) exclusivity for Fixed-Dose Combination (“FDC”) drugs continues to heat up. In a recent Petition for Reconsideration and Petition for Stay (Docket No. FDA-2013-P-0119), Ferring Pharmaceuticals, Inc. (“Ferring”) requestes that FDA reconsider its denial of …
By Kurt R. Karst – When we first heard about the Complaint and Motion for Preliminary Injunction Zogenix, Inc. filed against Massachusetts Governor Deval Patrick, among others, alleging that the Commonwealth’s ban on FDA-approved ZOHYDRO ER (hydrocodone bitartrate) Extended-release Capsules is unconstitutional because the ban …
By Riëtte van Laack – Legislation that would require labeling of genetically engineered or bioengineered foods (generally referred to as “GMOs”) has been proposed in various states. If enacted, these state laws may expose companies to a patchwork of different GMO labeling requirements. On April, 10, 2014, …
By Ricardo Carvajal & Diane B. McColl – When GAO issued its 2010 report criticizing FDA’s oversight of the GRAS exception, we were motivated to respond first in short form in a blog post, and then in long form through a Washington Legal Foundation Legal Backgrounder. …
By Riëtte van Laack – In 2006, the American Beekeeping Federation and honey industry groups petitioned FDA (Docket No. FDA-2006-P-0207) to adopt a standard of identity for honey. In 2011, FDA denied this petition because it concluded that no standard of identity was needed. FDA asserted …
By James C. Shehan – The Generic Pharmaceuticals Association (“GPhA”) opened a new front in its ongoing battle to shape the approval process for biosimilars, while also calling for more cooperation between the US and the EU in their oversight of traditional generic drugs. In a …
