By Kurt R. Karst – As we noted at the end of a post earlier this week (see here), we thought a lawsuit against FDA over the approval of generic versions of AstraZeneca’s quetiapine fumarate franchise – i.e., SEROQUEL (quetiapine fumarate) Tablets (NDA No. 020639) and …
By Jennifer M. Thomas & Jeffrey N. Wasserstein – Many pharmaceutical companies sponsor prescription drug coupons and other cost-savings programs to help reduce the burden of co-payments and co-insurance. Lawsuits filed against nine pharmaceutical companies in four federal district courts on March 7 by various union health …
By Ricardo Carvajal – FDA published its Food Safety Modernization Act ("FSMA") Domestic Facility Risk Categorization for FY2012, which distinguishes domestic high-risk ("HR") food facilities from non-high-risk (NHR) food facilities for purposes of determining frequency of inspection. For now, the determination of whether a facility is …
By Kurt R. Karst – Ever since FDA came up with the idea of a so-called “180-day exclusivity punt,” the Agency has taken a shine to using it with impunity, as a quick perusal of our 180-Day Exclusivity Tracker shows. FDA’s recent approval of ANDAs for …
By Riëtte van Laack – The United States District Court for the Southern District of Florida recently denied a motion by the Federal Trade Commission (“FTC”) to hold Garden of Life and its founder, Jordan S. Rubin (collectively “GOL”) in contempt for allegedly violating a court-issued …
By Alex J. Varond - On March 5, 2012, the Department of Veterans Affairs ("VA") issued a final regulation on promotion of drug and drug-related products (i.e., supplies related to the use of a drug, such as insulin needles and inhalers) by pharmaceutical company representatives at …
By Jeffrey K. Shapiro – We previously discussed the government’s brief in the Par case in the context of what it says about FDA’s draft Research Use Only guidance. However, the government’s brief in Par is worth examining from another angle. (Note: the Par case involves …
By John A. Gilbert & Larry K. Houck – On February 29, 2012, the Drug Enforcement Administration (“DEA”), exercising its emergency scheduling authority under 21 U.S.C. § 811(h)(2), extended the temporary scheduling of five synthetic cannabinoids: JWH-018, JWH-073, JWH-200, CP-47,497 and cannabicyclohexanol until August 29, 2012. …
By Ricardo Carvajal – In a letter that includes fun facts about the function of the epiglottis, FDA has warned Breathable Foods, Inc. that its AeroShot product is misbranded. The product’s labeling is alleged to be false and misleading because it contains contradictory statements regarding whether …
By Kurt R. Karst – Last week, as Congress, FDA, and industry continue to ramp up debate on what changes or modifications should be made to the FDC Act and PHS Act as part of a user fee package of bills expected to be enacted later …
By Riëtte van Laack & John R. Fleder – After the Federal Trade Commission (“FTC”) entered consent orders against Nestle and Iovate (see here), prohibiting future claims for respondents’ food and dietary supplements unless they are supported by two well-controlled clinical studies, the industry has been …
There was a recent piece on National Public Radio debating whether the golden age of blogging is over. One commentator suggested that moving forward, only the most successful blogs thus far (i.e., those blogs with a history of good content and that are able to …
By Ricardo Carvajal - Last November, we noted that FDA’s regulation requiring the display on cigarette packages of graphic warnings intended to dissuade would-be smokers appeared in jeopardy at the hands of U.S. District Judge Richard Leon in R.J. Reynolds et al v. FDA et al. …
By Riëtte van Laack – A coalition of public health associations sent a letter to FDA encouraging the agency to amend its ingredient statement regulation to include the single food ingredient “added sugars” followed by a parenthetical listing of the specific sugars added in descending order of …
On February 29th, FDA Commissioner Margaret A. Hamburg, M.D. announced in an FDA-wide e-mail the permanent appointment of Elizabeth H. Dickinson as FDA’s Chief Counsel. Ms. Dickinson has served as FDA’s Acting Chief Counsel since August 7, 2011 (see our previous post). Prior to that …
