In March 2004, California consumers filed a class action lawsuit against several grocery stores alleging that the stores violated California state law by failing to disclose the presence of the color additives astaxanthin and canthaxanthin in farmed salmon. The plaintiffs alleged that the lack of …
In an 8-to-1 decision, the U.S. Supreme Court held earlier this week that preemption principles and the 1976 Medical Device Amendments (“MDA”) bar common law claims on the basis of safety or effectiveness of devices approved by FDA under a Premarket Approval Application (“PMA”). The …
Last week, Apotex Inc. submitted an interesting Petition for Stay of Action to FDA requesting that the Agency recognize the company’s remaining 180-day exclusivity for its generic version of Sanofi-Synthelabo’s PLAVIX (clopidogrel bisulfate) by staying the effective date of final approval of other ANDAs (and …
In December 2007, we reported on what was a then yet-to-be-released FDA draft guidance on Good Reprint Practices (“GRPs”) and Rep. Henry Waxman’s (D-CA) November 30, 2007 letter to FDA strongly urging the Agency to refrain from disseminating the draft guidance and requesting certain information …
On February 7, 2008, the U.S. Department of Justice announced that Merck & Company, Inc. (“Merck”) agreed to pay more than $650 million to settle allegations that the company failed to pay proper rebates to Medicaid and paid illegal remuneration to health care providers to …
The debate over biogenerics legislation has intensified with the anticipated introduction of legislation to create a “generic biologics” approval pathway and that would grant innovators (i.e., reference product sponsors) and certain generic sponsors market exclusivity. The draft legislation obtained by FDA Law Blog is titled …
Our fellow bloggers over at The Volokh Conspiracy recently posted an interesting story concerning a congressional investigation into Merck/Schering-Plough’s cholesterol absorption inhibitor VYTORIN (ezetimibe; simvastatin). We previously reported on, among other things, a group of letters sent by the U.S. House of Representatives Energy and …
Yesterday, we reported that two Hyman, Phelps & McNamara, P.C. attorneys appeared on February 13, 2008, before the United States Sentencing Commission (“Commission”) regarding possible changes to the Sentencing Guidelines (“Guidelines”) that are applicable to certain FDA criminal offenses. That same day, three FDA officials …
We previously reported on the United States Sentencing Commission’s (“Commission”) proposed changes to its Sentencing Guidelines (“Guidelines”) that would likely greatly enhance the criminal penalties applied to some criminal violations of the FDC Act, including those added by the Prescription Drug Marketing Act of 1987 …
The latest issue of FDLI Update features an article by Hyman, Phelps & McNamara, P.C.’s Diane B. McColl and Susan J. Matthees. The article, titled “Nutrition Labeling: A Look at FDA’s Proposed Requirements,” provides an overview of FDA’s November 2, 2007 Advance Notice of Proposed …
The latest FDLI Update article by Hyman, Phelps & McNamara, P.C.’s Gwen M. McKee and John R. Fleder discusses the enforcement provisions of the Food and Drug Administration Amendments Act of 2007 (“FDAAA”). While the enforcement provisions of FDAAA have frequently been ignored in public …
On February 4, 2008, FDA announced that the Bush Administration is requesting nearly $2.4 billion ($1.77 billion in budget authority and $628 million in user fees) for the Agency as part of the Fiscal Year 2009 budget. Of particular interest in the proposed FY2009 budget …
Over the past few weeks, Congress has taken an acute interest in a broad range of FDA issues and FDA-regulated products, penning several letters and holding or expressing intent to hold hearings and investigations on various matters. Below is a list of recent congressional activity: On …
Earlier this month, U.S. House of Representatives Energy and Commerce Committee Chairman John Dingell (D-MI) and Oversight and Investigations Subcommittee Chairman Bart Stupak (D-MI) sent a letter to David M. Walker, Comptroller General of the U.S. Government Accountability Office (“GAO”) requesting that the Office update …
Earlier this month, we reported on a complaint filed by Nu-Pharm Inc. against FDA in the U.S. District Court for the District of Columbia seeking declaratory and injunctive relief with respect to the company’s Abbreviated New Drug Application (“ANDA”) #77-615 for generic divalproex sodium delayed-release …
