By Kurt R. Karst – It’s absolutely amazing how, after nearly 28 years, the 1984 Hatch-Waxman Amendments continue to provide surprises. Consider the latest example we came upon recently (with a little help) involving PRISTIQ (desvenlafaxine) Extended-Release Tablets. FDA approved PRISTIQ under NDA No. 021992 in a …
By Ricardo Carvajal – In tandem with the release of a House Energy and Commerce Committee staff report on last year’s outbreak of Listeria monocytogenes in cantaloupe, members of that committee sent Commissioner Hamburg a letter calling for reforms in the conduct and oversight of third-party audits. …
Pharmaceutical and medical device applicants faced with an adverse decision from FDA (e.g., regarding data requirements, study design, or regulatory pathway) may dispute that decision through multiple routes. The appeal processes in both CDER and CDRH offer numerous strategic and procedural advantages that, when used …
The American Conference Institute will be holding its FDA Boot Camp conference in New York City from Tuesday, March 20 to Wednesday, March 21, 2012. A copy of the conference program can be obtained here. Hyman, Phelps & McNamara, P.C.’s Kurt R. Karst will be …
By Kurt R. Karst – Last week, FDA Commissioner Margaret A. Hamburg, M.D. announced that the Agency sent to Congress packages for three user fee programs, including proposed statutory language for the fifth iteration of the Prescription Drug User Fee Act (“PDUFA V”), and two new …
By JP Ellison – An important issue relating to when an action by an administrative agency can be challenged in court was argued before the Supreme Court last week. The case involved administrative enforcement activities of the U.S. Environmental Protection Agency (“EPA”). The case, Sackett v. …
By Riëtte van Laack – USDA’s National Organic Program ("NOP") published a proposed rule that would amend the listing of vitamins and minerals in the National List of Allowed and Prohibited Substances (National List). The National List identifies non-agricultural synthetic ingredients that may be used in …
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 …
