By Kurt R. Karst – A recent report from the Government Accountability Office (“GAO”), titled “FDA Needs to Enhance Its Oversight of Drugs Approved on the Basis of Surrogate Endpoints,” finds that weaknesses in FDA’s monitoring and enforcement process have hampered the Agency’s ability to …
By Carrie S. Martin – On November 30, 2009, the United States Supreme Court will hear oral argument in Merck & Co. v. Reynolds, No. 08-905, a securities class action. The case concerns the standard of inquiry required to start the clock running on the …
By Ricardo Carvajal, David B. Clissold & Jeffrey K. Shapiro – FDA has published a draft guidance for industry on the listing of ingredients in tobacco products that manufacturers and importers are required to submit to the agency under FDCA section 904(a)(1). The FDCA does …
By John A. Gilbert and Larry K. Houck – Senate Special Committee on Aging Chairman Herb Kohl (D-WI) and Member Sheldon Whitehouse (D-RI) have sent a letter to U. S. Attorney General Eric Holder seeking improved access to needed pain and other medications for long-term care …
By Alan M. Kirschenbaum & Kurt R. Karst – Last Thursday we reported on the release by the House of H.R. 3962, the health care reform bill that will soon be considered on the House floor. As we have done with other health care reform …
By Ricardo Carvajal – FDA has again posted a warning letter to Procter and Gamble stating that the company’s VICKS DayQuil Plus Vitamin C and VICKS NyQuil Plus Vitamin C are unapproved new drugs and are misbranded. The letter states that, when “drug and dietary …
By Ricardo Carvajal – We’re used to seeing the Center for Science in the Public Interest ("CSPI") take a stick to food marketers. It seems that CSPI now has plenty of friends. First, Connecticut’s Attorney General trumpeted his success in gaining agreement from food companies …
JP Ellison – In March of 2008, we reported on a Wisconsin federal district court opinion that dismissed a plaintiff’s Lanham Act claim against three manufacturers of generic prescription drug products. On October 29, 2008, the Seventh Circuit issued a decision in an appeal of …
By William T. Koustas – On October 29, 2009, Judge Walton of the United States District Court for the District of Columbia ruled for the American Bar Association (“ABA”) and prevented the controversial Red Flags Rule (“the Rule”) from being enforced on November 1, 2009 …
By Kurt R. Karst – A recent report issued by the London School of Economics and Political Science (“LSEPS”), and commissioned by the Swedish government, urges governments to create new incentives to promote the research and development of antibiotics in light of the growing concern over …
By Jeffrey N. Wasserstein – On October 28, 2009, Michael Loucks, the Acting U.S. Attorney for the District of Massachusetts, announced that his office has recovered over $6.8 billion in healthcare fraud cases over the last 15 years, which is almost 30% of the total healthcare …
By Alan M. Kirschenbaum & Kurt R. Karst – Earlier today, House Speaker Nancy Pelosi (D-CA) unveiled the Affordable Health Care for America Act (H.R. 3962). The bill, which is the latest version of the House’s healthcare reform proposal and the one that will go …
By Dara Katcher Levy – On October 21, 2009, First Fishery Development Services filed suit against FDA seeking declaratory judgment and injunctive relief with regard to its product’s placement on Import Alert 99-08 – Detention Without Physical Examination of Processed Foods for Pesticides. According to the …
By Susan J. Matthees – On October 27th, on the heels of the release of the Government Accountability Office’s report in which the Office is critical of FDA’s oversight of clinical investigators (see our previous post), Rep. Joe Barton (R-TX) introduced H.R.3932, the Strengthening of …
By JP Ellison – Last year we posed the question “Are the Stars Lining Up for FDA Civil Penalties?” The intervening year has not answered that question, but a recent decision from the Tenth Circuit affirming civil penalties against TMJ Implants, Inc. (“TMJI”) and its founder …
