By Jeffrey N. Wasserstein & William T. Koustas – On November 12, 2008, Senate Finance Committee Chairman Max Baucus released a white paper detailing what he sees as the substantial problems in our health care system. The paper, titled “Call to Action: Health Reform 2009” …
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 Ricardo Carvajal – According to a web site set up by GAO to aid the 2009 congressional and presidential transition, the need to revamp oversight of food safety is one of several pressing issues that demand urgent attention. Since the early-1990’s, GAO has issued …
By Carrie S. Martin – On October 16, 2008, the U.S. District Court of the District of Columbia issued an opinion in Hays v. Leavitt holding that the “least costly alternative” policy implemented by the Centers for Medicare and Medicaid Services (“CMS”) was contrary to …
By Bryon F. Powell – On November 4, 2008, the United States District Court for the Middle District of Florida granted Defendants AstraZeneca’s and Parexel’s Motions to Dismiss in Ironworkers Local Union No. 68 v. AstraZeneca Pharmaceuticals LP. In this case, the Plaintiffs, various union …
By Kurt R. Karst – Earlier today, the U.S. Court of Appeals for the District of Columbia Circuit issued its opinion in Teva Pharmaceuticals USA, Inc. v. Leavitt. The case concerns the availability of 180-day exclusivity for a generic version of Janssen Pharmaceutica’s schizophrenia drug …
By Kurt R. Karst – Answer: "October 24, 2008" . . . . queue Jeopardy! think music . . . . Question: "What is the date on which patent information was first listed in the Orange Book covering an old antibiotic drug product?" Alex Trebek: "Correct!" On …
By Ricardo Carvajal – FDA recently published a notice of a proposed collection of information that solicits comments on the use of its new electronic system, called MedWatchPlus Portal, for the collection, submission, and processing of adverse event reports and other safety information for all …
By Diane B. McColl & Ricardo Carvajal – FDA has published a final rule and a draft Compliance Policy Guide (“CPG”) on prior notice of imported food shipments under the Bioterrorism Act of 2002 (“BT Act”). The final rule and draft CPG are available here. …
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 …
The FDA Law Blog would like to congratulate our colleagues Jim Phelps and Jeff Gibbs on being named among the best Food and Drug Lawyers in Washington, DC, according to "Washington DC's Best Lawyers," in association with the Legal Times. We've always thought they were …
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 – In its most recent response letters to New Dietary Ingredient ("NDI") notifications submitted pursuant to FDC Act § 413(a)(2), FDA included the following paragraph: Based on the information in your submission, it is possible that a recently enacted law may affect the legal status of …
