By Susan J. Matthees – The USDA’s Economic Research Service (“ERS”) recently published an article titled “Will Calorie Labeling in Restaurants Make a Difference?” that considers the potential impact of the new menu labeling requirements for chain restaurants. As we previously reported (here and here), § 4205 …
By Kurt R. Karst – In what is, to our knowledge, the first instance in which a company has asserted the patent delisting counterclaim provisions added by the Medicare Modernization Act (“MMA”) in the context of a 505(b)(2) application – and even in the context of …
By Kurt R. Karst – On March 7th, the U.S. Supreme Court denied yet another Petition for Writ of Certiorari concerning whether patent settlement agreements (what opponents call “pay-for-delay” agreements or “reverse payments”) are unlawful and violate the antitrust laws. As we previously reported, the case, …
By William T. Koustas – We have previously reported on the long running legal battle between the Federal Trade Commission (“FTC”) and the American Bar Association (“ABA”) over the implementation of the FTC’s Red Flags Rule (“the Rule”). Last Friday, the United States Court of Appeals …
Whether you say it in English, German (“Alles Gute zum Geburtstag FDA Law Blog!”), Hebrew (“Yom Huledet Same'ach FDA Law Blog!”), Hindi (“Janam Din ki badhai FDA Law Blog!”), Japanese (“Otanjou-bi Omedetou Gozaimasu FDA Law Blog!”), Zulu (“Ilanga elimndandi kuwe FDA Law Blog!”), or any …
By John R. Fleder & Anne K. Walsh – Perhaps Yogi Berra's most famous quote was: "This is like déjà vu all over again." Recently proposed amendments to the Sentencing Guidelines applicable to U.S. courts suggest that companies and their executives regulated by FDA may be …
By Karla L. Palmer & Larry K. Houck – Consistent with its November 24, 2010 Notice of Intent, the Drug Enforcement Administration (“DEA”) published its Final Order temporarily placing five synthetic cannabinoids into Schedule I under the Federal Controlled Substances Act (“CSA”) to avoid imminent hazard to …
By Kurt R. Karst – FDA’s Unapproved Drugs Initiative, which began in June 2006 when the Agency issued its final version of “Marketed Unapproved Drugs – Compliance Policy Guide Sec. 440.100,” took a major step with the Agency’s March 2, 2011 announcement that FDA plans to …
By Kurt R. Karst – Midnight, March 4, 2011 – that’s the time and date on which the federal government will close for business if Congress fails to approve a spending bill, or a short-term/stopgap funding measure that would likely just delay a shutdown for a …
By Susan J. Matthees – In an interesting twist in a developing story on the importation of thiopental, a drug used to administer the death penalty by lethal injection, the attorney for Georgia death row inmate Andrew Grant DeYoung sent Attorney General Eric Holder a …
By Carrie S. Martin – In a draft guidance issued on February 28, 2011, called “Medication Guides – Distribution Requirements and Inclusion in Risk Evaluation and Mitigation Services (REMS),” FDA proposes: (1) to implement a procedure that allows applicants with a REMS to request eliminating a …
By David B. Clissold – In a federal lawsuit filed on Friday, February 25, 2011 in the District of Columbia, Lorillard, Inc., Lorillard Tobacco Company, and R.J. Reynolds Tobacco Company sued the FDA, DHHS, Kathleen Sebelius, Margaret Hamburg, and Lawrence Deyton for declaratory and injunctive relief …
By Kurt R. Karst – In a win for compounding pharmacies and a loss for FDA, the U.S. Court of Appeals for the Fifth Circuit ruled last week in Med. Ctr. Pharmacy v. Holder that the U.S. District Court for the Western District of Texas violated …
By Ricardo Carvajal – FDA denied a citizen petition filed on behalf of OVOS Natural Health, Inc. (“OVOS”) that asked the agency to issue a regulation under FDC Act § 201(ff)(3)(B) or § 301(ll) acknowledging that marketing of homotaurine as a dietary ingredient in dietary supplements …
By Kurt R. Karst – It was just yesterday that we commented on how folks in the Hatch-Waxman community have been patiently awaiting FDA’s decision on an October 2010 citizen petition (Docket No. FDA-2010-P-0545) requesting that the Agency not approve any ANDA for a generic …
