By Jennifer M. Thomas – Last week, the Federal Trade Commission (“FTC”) hosted a workshop entitled “In Short: Advertising and Privacy Disclosures in a Digital World.” The workshop was intended to explore whether the FTC needs to revise its online advertising disclosure guidelines (“Dot Com Disclosures”), …
By Ricardo Carvajal - FDA denied a citizen petition submitted by the Corn Refiners Association ("CRA") which asked FDA to authorize the use of “corn sugar” as a common or usual name for high fructose corn syrup ("HFCS"), and to amend certain regulations that reference “corn …
By Kurt R. Karst – After a round of congratulatory speeches, the U.S. House of Representatives passed H.R. 5651, the FDA Reform Act of 2012, as amended, on May 30th by a vote of 387-5. Unlike the U.S. Senate, which passed its version of the bill …
By Kurt R. Karst – In a recent, 95-page decision from the U.S. District Court for the Eastern District of Pennsylvania in In re Wellbutrin XL Antitrust Litigation, the court once again tackled the issues of “sham” citizen petitions, liability under the Sherman Antitrust Act, and …
By Kurt R. Karst – We’re not economists, but we’re interested in the topic insofar as it concerns Congress’ consideration of FDA-related legislation, such as H.R. 5651, the FDA Reform Act of 2012, which is on tap for consideration by the U.S. House of Representatives later …
By Kurt R. Karst – After days of debate and a slew of proposed amendments, the U.S. Senate passed S. 3187, the FDA Safety and Innovation Act, on Thursday afternoon by a roll call vote of 96-1. Senator Bernie Sanders (I-VT), who cast the lone vote against passage, …
By Kurt R. Karst – FDA’s recent approval of ANDAs for generic versions of sanofi-aventis’ (“sanofi’s”) blockbuster blood thinner drug PLAVIX (clopidogrel bisulfate) Tablets (approved under NDA No. 020839) upon the May 17, 2012 expiration of a period of pediatric exclusivity associated with Orange Book-listed U.S. Patent …
By JP Ellison – Virtually all of the mainstream and trade press outlets have covered the recent Abbott resolution with the U.S. Department of Justice regarding allegations of off-label promotion of Abbott’s drug Depakote. Undoubtedly, the $1.5B price tag and that coverage have made most readers …
By Riëtte van Laack – On May 21, 2012, the FTC posted the 345-page Administrative Law Judge’s ("ALJ’s") Initial Decision in In the Matter of POM Wonderful LLC et al. ("POM") (FTC Docket No. 9344). The ALJ upheld the FTC’s Complaint insofar as the FTC asserted …
By Michelle L. Butler – Abbott Laboratories (“Abbott”) recently submitted a citizen petition to FDA regarding biosimilars under the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”). Specifically, the citizen petition requests that FDA not accept for filing, file, approve, or discuss with any company …
By Riëtte van Laack – Last week, the Food Safety and Inspection Service (“FSIS”) issued a proposal to lift the general prohibition against the use of sodium benzoate, benzoic acid, and sodium propionate in meat and poultry. Historically, the use of these substances in meat and …
By Kurt R. Karst – A lot has happened since we last updated our Generic Drug Labeling Carve-Out Citizen Petition Scorecard in October 2011. At that time, AstraZeneca had only recently submitted two citizen petitions concerning quetiapine fumarate (SEROQUEL and SEROQUEL XR). Petitions, FDA decisions, lawsuits, …
By Riëtte van Laack – On May 8, 2012, the Food Safety and Inspection Service (“FSIS”) published three sets of regulations mandated by the 2008 Farm Bill: (1) regulations requiring that meat and poultry plants promptly (within 24 hrs) notify FSIS that a contaminated or misbranded …
By Ricardo Carvajal – April was a busy month for nanotechnology at FDA. The agency issued two draft guidance documents worthy of close examination for those with an interest in the use of emerging technologies, including nanotechnology, in the cosmetic and food industries. Further, FDA denied …
By Jennifer D. Newberger – On May 7, 2012, Representative Lois Capps introduced the “Sentinel Assurance for Effective Devices Act of 2012” (H.R. 5341), many elements of which were also included in the House of Representatives Energy and Commerce Health Subcommittee user fee bill (see here). …
