It’s that time of year again when we ask our loyal FDA Law Blog readers for just a few minutes of their time. You got it: it’s the best legal blog nomination season! And this year, there are two contests for which we’re seeking your …
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Hyman Phelps McNamara
- It’s Nomination Season for the Best Legal Blogs; FDA Law Blog Needs Your Support!August 2nd, 2015
- FDA Publishes Fiscal Year 2016 User Fee Rates; Only a Modest Increase in PDUFA/BsUFA Rates, But Significant Hikes for Some GDUFA FeesAugust 2nd, 2015
By Kurt R. Karst – It’s that time of year again when FDA-regulated companies need to think about cracking open their checkbooks to pay FDA some pretty heft sums of cash for operations in the next fiscal year, and to plan ahead for submissions to …
- Senate Bill Would Protect Banks Serving Marijuana BusinessesJuly 30th, 2015
By Larry K. Houck – A bipartisan group of senators representing Oregon, Colorado and Washington, states that have legalized nonmedical use of marijuana, introduced legislation that would protect financial institutions from adverse action by federal banking regulators for providing services to legal marijuana businesses. The “Marijuana …
- The Veloxis Case: Uncut, Unrated, and Unsealed!July 30th, 2015
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 …
- FDASIA 706 and 711 Have Come Home to RoostJuly 28th, 2015
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from a number of large industry stakeholders and floating the idea for some time, FDA announced the availability of a Draft Guidance entitled “Request for Quality Metrics.” The Draft Guidance formally presents FDA’s current thinking and intentions …
- Who’s on First? FDA Raises the Specter of 180-Day Exclusivity Eligibility/Forfeiture for Generic RESTASIS and Asks If There’s a Phantom “First Applicant”July 28th, 2015
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 …
- FDA Proposes Daily Value for Added SugarsJuly 27th, 2015
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 …
- “Natural” vs. “Made With Natural Ingredients”July 27th, 2015
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 …
- Senate and House Lawmakers Add to FDA’s To-Do List in Fiscal Year 2016 Appropriations BillsJuly 24th, 2015
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 …
- FDA Releases White Paper on the Speed of Drug Discovery and DevelopmentJuly 22nd, 2015
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 …
- BPCIA Federal Circuit Follies, or Can We All Agree to Disagree? A Divided Federal Circuit Finds the Patent Dance Voluntary, But Rules that Notice of Commercial Marketing Can Occur Only After LicensureJuly 22nd, 2015
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 …
- House Agriculture Committee Approves The Safe and Accurate Food Labeling Act to Address GMO Labeling IssuesJuly 19th, 2015
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 …
- Erroneous FDA Guidance Continues to Plague IndustryJuly 17th, 2015
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? …
- A Walk Among the SBAs: Waxing Poetic on a Bygone Era, the Development of the Exclusivity Summary, and the Need for ChangeJuly 16th, 2015
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 …
- Washington DC Super Lawyers Magazine Names Five HP&M “Super Lawyers”July 15th, 2015
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 …