By Ricardo Carvajal & Diane B. McColl – The Grocery Manufacturers Association ("GMA") announced an initiative designed to “improve the process and increase transparency for making Generally Recognized As Safe ("GRAS") determinations of ingredients added to food.” The initiative includes the following five elements: Development by independent …
By Alan M. Kirschenbaum – We have reported previously (here and here) on PhRMA’s lawsuit challenging a HRSA regulation implementing the orphan drug exclusion that applies to certain types of covered entities under the 340B Drug Discount Program. To recap briefly, the rule had provided that …
By Jennifer D. Newberger – On August 20, 2014, CDRH issued a guidance document, “Unique Device Identifier System: Frequently Asked Questions, Vol. 1.” The purpose, according to the guidance, is to “provide[] clarification of key provisions of the UDI Rule.” We previously posted on the UDI rule …
By Kurt R. Karst – This blogger’s oldest child started middle school this past week. Naturally, I was excited to get his impressions of the first day of school. “Good” was his initial comment – a now all too familiar one-word tween response with which I …
By David C. Gibbons – It is rare that we urge our readers to keep a copy of a court ruling or brief. A Brief that FDA filed on August 21, 2014 is an exception. Companies and others should read this brief and keep it close …
By Riëtte van Laack – As previously discussed, since at least 2006, the U.S. honey bee industry has been trying to get FDA to adopt a standard of identity for honey. In 2006, the American Beekeeping Federation and honey industry groups petitioned FDA for a standard …
By Karla L. Palmer – The U.S. Drug Enforcement Administration (“DEA”) published last Friday a Final Rule rescheduling hydrocodone combination products (“HCPs”) from Schedule III to Schedule II. We posted about the proposed rescheduling here (NPRM published February 27, 2014). There was little doubt that DEA …
By Alan M. Kirschenbaum – Beginning with CY 2011, Section 9008 of the Patient Protection and Affordable Care Act (“ACA”) has imposed an annual fee on manufacturers and importers of “branded prescription drugs.” The global 2014 fee for all manufacturers and importers is $3 billion, to …
The Food and Drug Law Institute is sponsoring a conference titled "Food Safety: Latest FSMA Developments & Enforcement Actions in a Changing Business Climate," scheduled for September 9. The conference will feature a regulatory update by Michael Landa (Director of FDA/CFSAN), an exploration of the …
By Kurt R. Karst – The pace of litigation concerning FDA’s approval of generic versions of Hospira, Inc.’s (“Hospira’s”) PRECEDEX (dexmedetomidine HCl) Injection, 100 mcg (base)/mL packaged in 200 mcg(base)/2 mL single-dose vials, has been anything but sedate. On the morning of August 18, 2014, there …
By Jennifer D. Newberger – On August 14, 2014, FDA issued a draft guidance titled, “De Novo Classification Process (Evaluation of Automatic Class III Designation)” (draft guidance). The de novo review process, formally known as Evaluation of Automatic Class III Designation, is established by section 513(f)(2) of …
By Kurt R. Karst – We were beginning to wonder whether FDA would ever issue a letter decision addressing the novel issues raised in the Agency’s January 15, 2014 “Dear NDA/ANDA Applicant” letter (Docket No. FDA-2014-N-0087) concerning approval of generic versions of Hospira, Inc.’s (“Hospira’s”) PRECEDEX …
By Kurt R. Karst – The folks in FDA’s Office of Generic Drugs (“OGD”) have been especially busy as of late preparing for the October 1, 2014 implementation of the review and performance metrics agreed to under the Generic Drug User Fee Amendments of 2012 (“GDUFA”). …
By Kurt R. Karst – For several years now we’ve closely tracked the changes in user fees rates FDA sets each fiscal year under the Prescription Drug User Fee Act (“PDUFA”). Last year, we added rates set pursuant to the Generic Drug User Fee Amendments of …
By Kurt R. Karst – The Major Contribution to Patient Care (“MC-to-PC”) basis for demonstrating that an orphan drug is clinical superiority, and is therefore not the “same drug” as a previously approved orphan drug containing the same active moiety, is supposed to be a pretty …
