By Kurt R. Karst – It’s been almost seven weeks since the U.S. District Court for the District of Columbia issued its Opinion in Veloxis Pharmaceuticals. Inc. v. FDA, ___ F.Supp.3d ___, 2015 WL 3750672 (June 12, 2015), a challenge concerning the scope of 3-year new …
By Jay W. Cormier – On Monday, after seeking input from a number of large industry stakeholders and floating the idea for some time, FDA announced the availability of a Draft Guidance entitled “Request for Quality Metrics.” The Draft Guidance formally presents FDA’s current thinking and intentions …
By Kurt R. Karst – A “phantom” is defined, in part, to mean “an appearance or illusion without material substance, as a dream image, mirage, or optical illusion.” That’s probably the best way to sum up what’s at the heart of the issues raised by FDA …
By Riëtte van Laack – Last week, FDA announced a supplemental proposal to amend the nutrition labeling regulation for food and dietary supplements, and the availability of consumer studies related to FDA’s proposed changes to the format of the Nutrition Facts box. Undoubtedly, the proprosal to establish …
By Ricardo Carvajal - The distinction between the claims “natural” and “made with natural ingredients” is among the issues addressed in a recent NAD decision involving advertising for ASPIRE, a brand of sports drinks promoted as “all natural” and “natural sports drinks.” The drinks include vitamins and citric …
By Kurt R. Karst – Earlier this month, legislation was introduced in both the U.S. Senate and U.S. House of Representatives to fund FDA for the next fiscal year: Fiscal Year 2016. Both the Senate bill and the House bill, titled “Agriculture, Rural Development, Food and …
By Alexander J. Varond – In a recent FDA Voice blog post, titled “More Collaboration, Research Needed to Develop Cures,” FDA discusses the speed of drug discovery and development. The blog post also references a white paper released the same day, titled “Targeted Drug Development: Why …
By James C. Shehan & Kurt R. Karst – On July 21, 2015, a fractured Federal Circuit issued its decision in the dispute between Amgen and Sandoz concerning various statutory issues under the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”). In a result that few …
By Riëtte van Laack – On July 14, the House Agriculture Committee approved The Safe and Accurate Food Labeling Act (H.R. 1599), advancing the legislation another step in the long legislative process. The Act is an amended version of legislation introduced in March by Representative Mike Pompeo (R-KS). (a copy …
By Wes Siegner – In 2005, FDA published a Dietary Supplement Labeling Guide that, among other things, provided guidance on whether the words “Dietary Supplement” by themselves satisfied the requirement that the front panel of all dietary supplement products include a statement of identity. FDA’s answer? …
By Kurt R. Karst – As the years go by and nostalgia creeps in, we reminisce about the past and how things were “back then” (which to this blogger means the 1980s and 1990s). It’s not that things were necessarily better “back then,” they were just …
Hyman, Phelps & McNamara, P.C. (“HP&M”) is happy to announce that five of the firm’s attorneys have been named “Super Lawyers” in the Washington, D.C. area in the 2015 Washington DC Super Lawyers Magazine. Super Lawyers is a rating service of outstanding lawyers from more …
By Alexander J. Varond – On July 10, 2015, the U.S. House of Representatives passed the 21st Century Cures Act. In all, there were 344 “yes” votes and only 77 “no” votes, with half of the “yes” votes coming from Republicans and the other half coming …
By James C. Shehan – On July 9, 2015, Representatives Matt Salmon (R- AZ), Paul Gosar (R-AZ) and Marlin Stutzman (R-IN) introduced H.R. 3012, the Right to Try Act of 2015. The bill seeks to expand the access of terminally ill patients to experimental drugs in …
By Etan J. Yeshua – Last week, FDA announced that it will be extending by one year the compliance date for its menu labeling rule. This means that restaurants and other establishments covered by the rule, and by the menu labeling provisions of the Affordable Care …
