By John A. Gilbert and Larry K. Houck – The Drug Enforcement Administration (“DEA”) has published a notice of proposed rulemaking to control Tapentadol as a schedule II substance under the Controlled Substances Act. Schedules of Controlled Substances: Placement of Tapentadol Into Schedule II, 74 Fed. Reg. 7,386 …
By Kurt R. Karst – 2008 was a banner year for orphan drug designations. FDA’s Office of Orphan Products Development (“OOPD”), which, since September 2007, has been under the leadership of Timothy Coté, M.D., M.P.H., designated a record 165 products for orphan (i.e., rare) diseases …
By John A. Gilbert & Larry K. Houck – WMSN-TV Fox 47 of Madison, Wisconsin, recently reported that pharmacies are experiencing difficulty obtaining oxycodone to fill their patients prescriptions. Oxycodone, a schedule II opioid painkiller, is indicated for patients suffering from moderate to severe pain. …
By J.P. Ellison – Twenty-Seven Attorneys General have given FDA prior approval authority over Bayer’s Direct-to-Consumer (“DTC”) television and print advertising for its prescription oral contraceptive Yaz, and also required to company to run a $20 million corrective advertising campaign as part of a settlement agreements with …
By Bill T. Koustas – On February 9, 2009, FDA (or “the Agency”) announced it has invited the sponsors of opioid drug products to a private meeting in March in order to begin the process of developing Risk Evaluation and Mitigation Strategies (“REMS”) that will …
By Ricardo Carvajal – Disagreeing with an earlier New Jersey district court decision, a California district court has ruled that there is no federal preemption of an unfair competition claim against the manufacturer of a food that contains high fructose corn syrup ("HFCS") and is labeled …
By Jamie K. Wolszon – On January 21, 2009, the California Supreme Court decided that it would not review a remarkable California appeals court decision that a brand-name drug manufacturer could be liable for an adverse event the plaintiff suffered as a result of taking …
By Michelle L. Butler – With the effective date for a number of requirements imposed by the Consumer Product Safety Improvement Act (“CPSIA”) quickly approaching (February 10, 2009), the Consumer Product Safety Commission engaged in a flurry of activities. We recently reported on the Commission’s decision …
By Ricardo Carvajal – FDA has approved the biological product ATryn, an anticoagulant derived from the milk of genetically engineered ("GE") goats. The approval follows on the heels of the agency’s issuance of long-awaited guidance on its regulatory approach to GE animals, which we discussed …
Hyman, Phelps & McNamara, P.C.’s Anne Marie Murphy will present at the International Consumer Product Health and Safety Organization’s (“ICPHSO’s”) 16th Annual Meeting and Training Symposium, which is scheduled to take place from February 24-27, 2009 at the Florida Hotel and Conference Center in Orlando, …
By Ricardo Carvajal & Susan J. Matthees – The FDA Globalization Act (“FDAGA”) of 2008 was “meant to stimulate discussion about how to provide adequate funding and authority for FDA to ensure safety” of products over which the agency has jurisdiction. When we commented on …
By Ricardo Carvajal – USDA has suspended, and proposes to debar, Peanut Corporation of America ("PCA") from “participating in government contracts or subcontracts, as well as federal non procurement programs,” among other activities. The suspension is for one year and is effective immediately. The proposed debarment …
The Center for Business Intelligence (“CBI”) will hold its 2nd Annual Summit on Biosimilars and Follow-On Biologics on March 10-11, 2009. The Conference will be held at the Marriott Baltimore Inner Harbor at Camden Yards in Baltimore, Maryland. A copy of the conference brochure is …
By Kurt R. Karst – The American Intellectual Property Law Association (“AIPLA”) recently submitted a letter to FDA concerning § 4 of the recently enacted “QI Program Supplemental Funding Act of 2008” (the “QI Act”). (The "QI" stands for Qualifying Individual). As we previously reported, …
By Ricardo Carvajal – In January 2008, FDA received a citizen petition asking it to “issue a formal determination that when applied to foods and dietary supplements, California's Proposition 65 causes consumer confusion, ‘misbrands’ safe and wholesome products, and frustrates FDA's ability to carry out …
