By Karla L. Palmer & John A. Gilbert – On September 8, 2011, the Drug Enforcement Administration (“DEA”) published a Notice of Intent to temporarily place into Schedule I of the Federal Controlled Substances Act (“CSA”) three synthetic cathinones. 75 Fed. Reg. 55616 (Sept. 8, 2011). …
By Kurt R. Karst – On September 8th, the U.S. Senate passed, by an 89-9 vote, H.R. 1249, the Leahy-Smith America Invents Act. Final passage of the bill, which will make significant changes to the U.S. patent system, was preceded by a contentious vote on, you …
On September 9, 2011, FDA will publish in the Federal Register a notice granting a 60-day extension, until December 2, 2011, to file comments on the draft guidance on New Dietary Ingredient (“NDI”) notifications that the Agency issued on July 5, 2011 (see our previous …
By Kurt R. Karst – The National Organization for Rare Disorders (“NORD”) announced the submission of a Citizen Petition to FDA requesting “that a documented policy be established regarding the review of potential treatments for people with rare diseases.” The petition comes on the heels of …
By Riëtte van Laack – On August 24, 2011, another class action suit regarding “natural” food labeling claims was filed in the Southern District of California. The defendants include Kashi Co. (“Kashi”) and its general manager, as well as Kashi’s parent Kellogg Co. and its President …
By Kurt R. Karst – Last week, FDA issued its highly anticipated Proposed PDUFA V Reauthorization Performance Goals and Procedures for Fiscal Years 2013 through 2017, which were hammered out between FDA and industry after long negotiations. The proposal includes several new provisions compared to the …
By Kurt R. Karst – A recent Citizen Petition submitted on behalf of Abbott Laboratories (“Abbott”) calls into question FDA’s authority for granting Therapeutic Equivalence (“TE”) ratings (i.e., “A” ratings) for drug products approved pursuant to FDC Act § 505(b)(2). Specifically, Abbott’s petition requests that FDA …
By Kurt R. Karst – In what appears to be the first instance in which a court has considered the U.S. Supreme Court’s decision in PLIVA, Inc. v. Mensing in the context of a preemption defense in a state tort-law failure-to-warn case, Nevada State Court Judge Jerry …
By Ricardo Carvajal – FDA published a Federal Register notice asking for nominations of individuals to serve as voting members on the Tobacco Products Scientific Advisory Committee ("TPSAC"). The TPSAC has been ensnared in controversy due to allegations of bias and conflicts of interest among current …
By Kurt R. Karst – In a Report to Congress issued earlier this year and recently made public, FDA’s Rare Disease Group (“RDG”) and Neglected Tropical Disease Group (“NTDG”) report on their findings and recommendations to improve the current regulatory/scientific armamentarium to facilitate the development of …
By Kurt R. Karst – On August 31, 2011, the Federal Trade Commission (“FTC”) announced the issuance of its final report, titled “Authorized Generic Drugs – Short-Term Effects and Long-Term Impact,” which has been in the works for years since it was requested in 2005 by …
By Anne Marie Murphy – This week FDA announced the publication of a draft guidance titled, “Oversight of Clinical Investigations: A Risk Based Approach to Monitoring.” This is the first time since 1988 that the agency issued a specific guidance document on how a study sponsor …
By Ricardo Carvajal – In June, we reported that the DC Circuit Court of Appeals decided it lacked exclusive jurisdiction over a Natural Resources Defense Council (“NRDC”) citizen petition seeking FDA action against BPA. Undeterred, NRDC has now filed its complaint in district court. The complaint …
By Kurt R. Karst – On August 29, 2011, Public Citizen announced that it submitted a citizen petition to FDA requesting that the Agency amend its regulations to permit ANDA sponsors to revise their labeling through the Changes Being Effected (“CBE”) and Prior Approval Supplement (“PAS”) …
By Riëtte van Laack – Under the law, a manufacturer of a new dietary ingredient ("NDI") or a dietary supplement containing an NDI must notify FDA of the basis for the manufacturer’s conclusion that its product “will reasonably be expected to be safe.” FDA’s regulation, 21 …
