By Jamie K. Wolszon – FDA’s recent decision to require a Risk Evaluation and Mitigation Strategy (“REMS”) for two prescription oral sodium phosphate (“OSP”) products raises questions regarding the impact the agency’s evolving application of its new REMS authority will have in instances where both …
By John R. Fleder & Kurt R. Karst – On December 10, 2008, the United States District Court for the Northern District of Illinois in Chicago dismissed a federal False Clams Act qui tam action in U.S. ex rel. Kennedy v. Aventis Pharmaceuticals, Inc. involving allegations of off-label …
By Kurt R. Karst – Earlier today, by a five-to-four vote, the U.S. Supreme Court ruled against preemption in Altria Group, Inc. Good, the so-called “light cigarette” case. Background on the case is available via the SCOTUS Wiki. The respondents in the case (i.e., Good …
By Kurt R. Karst – We previously reported on concerns as to whether a company submitting an ANDA (or a 505(b)(2) application) containing the results of an in vivo bioequivalence study must certify on Form FDA 3674 that new Public Health Service Act (“PHS Act”) …
By Anne Marie Murphy – We have previously reported on the Consumer Product Safety Improvement Act of 2008 (“CPSIA”) (here, here, and here), which makes a number of changes to the laws enforced by the Consumer Product Safety Commission (“CPSC”). Section 102(a)(1) of the CPSIA …
By Jeffrey N. Wasserstein, Alan M. Kirschenbaum & Bryon F. Powell – On December 10, 2008, the Massachusetts Department of Public Health (Department) issued proposed regulations pursuant to Mass. Gen. L. § 111N, which requires the Department to promulgate regulations that adopt a standard marketing code …
By Cassandra A. Soltis – FDA has posted on its web site two revised draft guidance documents (here and here) concerning the labeling requirements of dietary supplements and over-the-counter (OTC) drugs under the Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006. That Act …
By Susan J. Matthees – FDA recently announced the availability of a new draft guidance document on the types of information FDA recommends be included in a complete submission for the evaluation of proprietary names for prescription drug products, biologics, and nonprescription drug products that …
By Bryon F. Powell – On November 26, 2008, the Massachusetts Department of Public Health delayed plans to propose emergency regulations that would implement the state’s recently enacted pharmaceutical and device marketing law at a December 10 meeting of the Public Health Council. A pair …
By Michelle L. Butler – We previously posted on the expanded certification requirements mandated by section 102(a)(1) of the Consumer Product Safety Improvement Act of 2008 (“CPSIA”). Today, the Consumer Product Safety Commission (“CPSC”) published on its website an immediate final rule regarding these certification …
By James R. Phelps – On November 7, 2008, the First Appellate District in the Court of Appeal of the State of California, which sits in San Francisco, issued a remarkable decision in Conte v. Wyeth, Inc. The court said: “We hold that the common law …
By Kurt R. Karst – Commissioner Pamela Jones Harbour of the Federal Trade Commission (“FTC”) recently gave a speech, titled “The Federal Trade Commission’s Perspective on Biosimilars: Current Initiatives and Long-Term Goals.” This is at least the second speech in which Commissioner Harbour has address …
By Kurt R. Karst – Your loyal and intrepid bloggers were in attendance at today's argument before the U.S. Supreme Court in Wyeth v. Levine. The case has been billed by some as the business case of the century; however, we think such hype is …
By Kurt R. Karst – Happy Halloween! Earlier this week, Health News Daily reported that Dr. Sidney Wolfe, Director of Public Citizen’s Health Research Group, was named a permanent member of FDA’s Drug Safety and Risk Management Advisory Committee. A copy of Dr. Wolfe’s Curriculum …
By Ricardo Carvajal & Kurt R. Karst – On October 28, 2008, FDA announced that the Agency issued Warning Letters to Bayer HealthCare contending that two of Bayer’s products, Bayer Women’s Low Dose Aspirin + Calcium and Bayer Aspirin with Heart Advantage (Heart Advantage), are unapproved …
