In June, the U.S. Patent and Trademark Office (“PTO”) determined that AstraZeneca’s U.S. Patent No. 5,674,860 (“the ‘860 patent”), which covers the drug product SYMBICORT (budesonide; formoterol fumarate dihydrate) Inhalation Aerosol, is ineligible for a Patent Term Extension (“PTE”). The PTO’s decision is important in …
On June 26, 2008, ranking Republican of the U.S. House of Representatives Energy and Commerce Committee, Representative Joe Barton (R-TX), along with several co-sponsors, introduced the “Strengthening of FDA Integrity Act of 2008” (H.R. 6378). According to an Energy and Commerce Committee Republicans press release, …
On June 27, 2008, the U.S. Drug Enforcement Administration (“DEA”) published a much anticipated Notice of Proposed Rulemaking Regarding Electronic Prescriptions for Controlled Substances. The proposed regulations are in addition to existing prescribing requirements for controlled substances and are expected to work in tandem with …
On June 11, 2008, the Accreditation Council for Continuing Medical Education (“ACCME”) issued for comment a proposal “that the commercial support of continuing medical education end.” The proposal is intended to provoke debate on whether unbiased CME is possible when funded by individual pharmaceutical or …
On June 27, 2008, the District of Columbia Department of Health proposed regulations to implement Title 1 of the SafeRx Amendment Act of 2008 (“SafeRx Act”), which FDA Law Blog previously reported on in January 2008. Under the proposed regulations, pharmaceutical detailers in the District …
Are state law personal injury suits against drug and device manufacturers preempted by federal regulation of these products? This question has been the subject of much litigation since the early 1990s. The U.S. Supreme Court has issued a string of decisions in this area, with one …
On June 5, 2008, a citizen petition was submitted to FDA requesting that the Agency “initiate rulemaking proceedings addressing the authoritative statement nutrient content claim provisions” of the Federal Food, Drug, and Cosmetic Act (“FDC Act”). The petition takes issue with FDA’s November 27, 2007 …
On June 23, 2008, Representative William Delahunt (D-MA) introduced, and the U.S. House of Representatives quickly passed by voice vote, H.R. 6344 – the Responsive Government Act of 2008. The 12-page bill includes several provisions, including the latest iteration of the so-called “Dog Ate My …
On June 2, 2008, First DataBank, a private publisher of prescription drug prices in the United States, announced a new proposed settlement in a class action suit alleging that the company conspired with a wholesaler to inflate the Average Wholesale Price (“AWP”) for certain prescription …
On April 3, 2008, Representatives Frank Pallone, Jr., (D-NJ), Chairman of the House Energy and Commerce Committee Subcommittee on Health, and Nathan Deal (R-GA), ranking Republican of the Subcommittee on Health, sent a letter to a diverse group of 35 stakeholders, such as AARP, PhRMA, …
On June 6, 2008, Wyeth Holdings Corporation and its Fort Dodge Animal Health Division (collectively “Wyeth”) filed a complaint in the U.S. District Court for the District of Columbia against FDA and the U.S. Patent and Trademark Office (“PTO”) requesting declaratory and injunctive relief with …
Hyman, Phelps & McNamara, P.C., the nation’s largest dedicated food and drug practice, seeks a mid-level associate experienced in drug/biologics development and approval for our D.C. office. The ideal candidate will have a scientific or medical background and prior regulatory experience in drug/biologics development issues …
The German Federal Institute for Risk Assessment (“BfR”) has issued a report that discusses recent human data on potential health risks arising from consumption of energy drinks. According to the report, the safety concerns expressed by BfR in a prior expert opinion are “substantiated by …
In a case involving a highly unusual set of facts for FDA-regulated companies, Leiner Health Products, Inc. (Leiner) is seeking to have a plea agreement approved by a Bankruptcy court. The case involves violations of Current Good Manufacturing Practices (cGMPs) for over-the-counter drugs. What also …
FDA has filed an amicus curiae brief with the Second Circuit Court of Appeals that supports a New York City (“NYC”) law requiring all menu boards and menus in chain restaurants with 15 or more establishments nationally to bear calorie content information for each menu …
