By Larry K. Houck – The Drug Enforcement Administration (“DEA”) published its long awaited notice of proposed rulemaking to implement the Secure and Responsible Drug Disposal Act of 2010 (“Disposal Act”). 77 Fed. Reg. 75,784 (Dec. 21, 2012). Interested persons should submit electronic comments on …
By Ricardo Carvajal – Signaling potential movement on an issue that has bedeviled industry, FDA published a notice requesting comments “relevant to conducting a risk assessment to establish regulatory thresholds for major food allergens.” Undeclared major food allergens continue to be one of the two principal …
By Jennifer D. Newberger & Jeffrey N. Gibbs – A quick Google search of “dog trained to identify medical conditions” indicates that, around the world, dogs are already working with people to help sniff out certain medical conditions. For example, in the United Kingdom an organization …
By Riëtte van Laack – District Judge Susan Nelson of the District of Minnesota recently concluded that FDA is best qualified and has been authorized by Congress to decide whether Milk Protein Concentrate (“MPC”) is a “proper, permitted ingredient in yogurt.” Earlier this year, on March …
Hyman, Phelps & McNamara, P.C. is pleased to announce that Diane B. McColl has been elected to serve as the new President of the International Society of Regulatory Toxicology and Pharmacology (“ISRTP”). ISRTP’s mission is to provide an open public forum for policy makers and …
By Larry K. Houck – The Drug Enforcement Administration (“DEA”) published a notice of proposed rulemaking in the December 19th Federal Register (77 Fed. Reg. 75,075 (Dec. 19, 2012)) to place lorcaserin into schedule IV of the federal Controlled Substances Act (“CSA”). Interested persons must …
Hyman, Phelps & McNamara, P.C. Director David B. Clissold will be speaking at an upcoming Management Forum conference on myriad topics, including orphan drug exclusivity, FDA regulatory strategies, and advanced therapy products. The conference, titled “EU and US Regulatory Issues for IP Professionals,” will take …
By Kurt R. Karst – The Pharmaceutical Research and Manufacturers of America (“PhRMA”), the Biotechnology Industry Organization (“BIO”), and the Generic Pharmaceutical Association (“GPhA”) share some common ground. All three of the trade groups oppose a Safe Drug Disposal Ordinance (see here and here [Item …
By Alexander Varond – On December 14, FDA released a draft guidance document entitled “Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products” (“Enrichment Guidance”). The thirty-nine-page document was more than six years in the making and aims to provide …
By Ricardo Carvajal – FDA announced that it executed a Food Safety Systems Recognition Arrangement ("RA") with its counterpart in New Zealand, the Ministry for Primary Indsutries ("PMI"). The RA is the culmination of an assessment that began in 2010 and included both paper and on-site …
By Kurt R. Karst – Excitement over the U.S. Supreme Court’s recent decision to hear Federal Trade Commission v. Watson Pharmaceuticals, Inc. (Docket No. 12-416), a drug patent settlement agreement (a.k.a. “reverse payment” or “pay-for-delay agreement”) case involving ANDROGEL (testosterone gel) (see our previous post …
By Carmelina G. Allis – Earlier this month, the IRS published final regulations and interim guidance on the excise tax imposed on the sale of certain medical devices intended for human use pursuant to the Health Care and Education Reconciliation Act of 2010 and the Patient Protection …
By Etan Yeshua – Manufacturers of foods, drugs and cosmetics might possibly be able to label their products as “Carcinogen-Free” with federal approval. In November, Rep. Theodore Deutch (D-FL) and Rep. Sue Myrick (R-NC) introduced the "Carcinogen-Free Label Act of 2012" (H.R. 6601), which would …
As we promised in an earlier post, we provide here a deeper analysis of the Second Circuit’s holding in United States v. Caronia and the context in which it should be viewed by industry. Since the 2004 Warner-Lambert settlement, the federal government has investigated hundreds …
By Ricardo Carvajal – We previously reported on a lawsuit that seeks to compel OMB and FDA to accelerate the implementation of FSMA. Now the government has filed a motion to dismiss the case and for summary judgment. The motion provides a full accounting of …
