By Kurt R. Karst – FDA recently denied a 2008 citizen petition (Docket No. FDA-2008-P-0291) requesting that the Agency amend its drug label regulations to require that product labels include the Orange Book-listed NDA number under which the product is approved. According to the petition, “[i]ncreasingly, …
By Riëtte van Laack – The Animal Medicinal Drug Use Clarification Act of 1994 (“AMDUCA”) amended the FDC Act § 512(a) allowing veterinarians to prescribe extralabel use of certain approved animal and human drugs for animals. (Extralabel use includes use in species not listed in the …
By Riëtte van Laack – In a strongly worded letter to FDA Commissioner Hamburg dated December 22, 2011, the principal authors of the Dietary Supplement Health and Education Act of 1994 (“DSHEA”), Senators Orrin Hatch (R-UT) and Tom Harkin (D-IA), requested that FDA immediately withdraw the …
By Kurt R. Karst – In what appears to be the first federal court decision on the so-called Reference Listed Drug (“RLD”) theory of liability, Judge Marvin H. Shoob of the U.S. District Court for the Northern District of Georgia (Atlanta Division) recently ruled in Moore …
By Riëtte van Laack – On January 3, 2012, the U.S. Pharmacopeial Convention (“USP”), a scientific organization that publishes the Food Chemical Codex (“FCC”), an international compendium of quality specifications for food ingredients, announced proposed standards for probiotic food ingredients. The proposed standards will be included …
By Jeffrey K. Shapiro, Jeffrey N. Gibbs & Jennifer D. Newberger – It is essential to FDA’s proper functioning that stakeholders have a viable appeals process. This means a process that is timely, transparent, and fair. A viable appeals process is an essential “check and balance” …
By Susan J. Matthees – Earlier this week, the U.S. Court of Appeals for the District of Columbia Circuit affirmed the U.S. District Court for the District of Columbia’s decision granting FDA’s Motion to Dismiss a lawsuit filed in April 2010 by a group of ear …
By Kurt R. Karst – In what appears to be a further sign of FDA’s efforts to clamp down on differences between brand-name Reference Listed Drugs (“RLDs”) and their proposed generic counterparts, FDA’s Office of Generic Drugs (“OGD”) is now looking more closely at tablet size …
By James R. Phelps – Over the New Year's Day weekend, The New York Times reported on the shortage of ADHD drugs, with this quote: “‘We have reached out to the D.E.A. and told them that there are shortage issues,’ said Valerie Jensen, associate director of …
The Food and Drug Law Institute’s (“FLDI”) annual Food Week Conference is being held in Washington, DC on January 23-26, 2012. FDLI Food Week features a two-day introduction to food law and regulation, as well as three days of advanced programming on advertising and labeling, …
By Kurt R. Karst – Representatives Cliff Stearns (R-FL) and Ed Towns (D-NY) recently introduced H.R. 3737, the Unlocking Lifesaving Treatments for Rare-Diseases Act (“ULTRA”). The bill would amend the FDC Act to “improve access to the existing accelerated approval pathway for patients with life threatening …
By Ricardo Carvajal – Several nonprofit groups sued FDA for its failure to respond to a May 2006 citizen petition asking that products of nanotechnology be subject to specific regulatory requirements, and that FDA stop the marketing of sunscreens that contain nanoparticles. The complaint alleges that …
By Jennifer D. Newberger – To finish out a year in which the Center for Devices and Radiological Health ("CDRH") issued what appeared to be an unprecedented number of draft guidance documents, CDRH issued two more on December 27, 2011. This blog post discusses one such …
By Jamie K. Wolszon & Alan M. Kirschenbaum – FDA has issued two important documents bearing on communications regarding off-label uses and (in one of the documents) not-yet-approved products. The first, which was posted on FDA’s web site earlier this week, was a draft guidance on …
By Ricardo Carvajal – Earlier this month, the HHS Office of Inspector General ("OIG") issued a report that identifies a number of “significant weaknesses” in FDA’s oversight of food facility inspections conducted by state agencies under contract with FDA. OIG found that FDA: “failed to ensure that …
