By Nisha P. Shah – Under a bill titled, “An Act to Make Certain Prescription Drug Disclosure Laws Consistent with Federal Law,” the State of Maine repealed three laws related to the reporting of marketing costs, price reporting, and the disclosure of clinical trials by manufacturers …
By Larry K. Houck – The Drug Enforcement Administration (“DEA”) published a Notice of Proposed Rulemaking (“NPRM”) on July 6, 2011 seeking to raise initial registration and renewal fees for all registrants. 76 Fed. Reg. 39,318 (July 6, 2011). Citing increased diversion control activities, DEA justified …
FDA Law Blog has learned that Elizabeth H. Dickinson, who currently serves as Associate Chief Counsel for Drugs in FDA’s Office of Chief Counsel, will serve as FDA’s Acting Chief Counsel effective on August 7th. As we previously reported, FDA’s current Chief Counsel, Ralph Tyler, recently …
By Dara Katcher Levy – On July 5, 2011, seven pharmaceutical companies submitted a joint Citizen Petition requesting that FDA clarify its policies for industry about four distinct types of manufacturer-communications that often deal with off-label information – Manufacturer Responses to Unsolicited Requests; "Scientific Exchange"; Interactions …
By Kurt R. Karst – A recent article in The RPM Report concerning the apparent fate of the only Priority Review Voucher (“PRV”) issued to date by FDA caught our attention. Kudos to The RPM Report team, which took note of some statements made during a …
By Riëtte van Laack – Last week, Senator Richard Durbin (D-IL) introduced “the Dietary Supplement Labeling Act of 2011” (S. 1310). The bill proposes to amend the Federal Food, Drug, and Cosmetic Act (“FDC Act”) to “improve the safety of dietary supplements.” Durbin’s bill includes a …
By Kurt R. Karst – Earlier this week, Judge Joel A. Pisano of the U.S. District Court for the District of New Jersey issued a 19-page decision in Nostrum Pharmaceuticals, LLC. v. FDA denying the injunctive relief sought by Nostrum in a Complaint and a Motion …
By Riëtte van Laack – The Food Safety Modernization Act ("FSMA") required that FDA, within 180 days of enactment of the FSMA, publish guidelines clarifying the definition of a new dietary ingredient ("NDI") and requirements for NDI notifications. FDA just made that deadline when it released …
By Kurt R. Karst – Over the Independence Day holiday, in between the family BBQ and fireworks, we had a few minutes to reflect on what a hectic month June was for FDA and the regulated industry. There were the decisions handed down by the U.S. …
By Peter M. Jaensch – On June 29th, 2011, the Washington Legal Foundation (“WLF”) filed an amicus curiae brief in Friedman v. Sebelius, currently pending in the U.S. Court of Appeals for the D.C. Circuit. WLF argues that excluding executives convicted of misdemeanor offenses under the …
By Kurt R. Karst & Jeffrey K. Shapiro – French company PREVOR has filed a Complaint in the U.S. District Court for the District of Columbia challenging FDA’s determination that PREVOR’s Diphoterine® Skin Wash (“DSW”) is a drug-device combination product with a “drug” primary mode of …
About 18 months after coming to FDA to serve as Chief Counsel, Ralph Tyler will be leaving the Agency, according to an FDA-wide e-mail sent out on June 30th by FDA Commissioner Margaret Hamburg. Prior to joining FDA, Mr. Tyler served as Insurance Commissioner of …
By Kurt R. Karst – A recent unpublished decision out of the U.S. District Court for the District of New Jersey presented an interesting public disclosure issue that we think will be of interest to the Hatch-Waxman community. The case, like so many Hatch-Waxman cases, is …
By Kurt R. Karst – The continuing court battle over a Patent Term Extension (“PTE”) for U.S. Patent No. 5,196,404 (“the ‘404 patent”) covering The Medicines Company’s (“MDCO’s”) ANGIOMAX (bivalirudin) could be derailed if a recent amendment added to the House version of the America Invents …
By Dara Katcher Levy – Last week, FDA’s Division of Drug Marketing, Advertising, and Communications (“DDMAC”) released an Untitled Letter issued to Novartis on May 31st, which alleges the company made unsubstantiated superiority claims in a detail aid for its ADHD drug, Focalin XR. Unlike most …
