By Susan J. Matthees – The Federal Trade Commission (“FTC”) recently announced that an Administration Law Judge (“ALJ”) upheld FTC’s charges against a company, Daniel Chapter One, and its officer, James Feijo, for making claims that its shark cartilage and herbal supplements prevent, treat, and …
By Ricardo Carvajal – In conjunction with other plaintiffs, the Alliance for Natural Health has filed suit in the D.C. district court challenging FDA’s denial of plaintiffs’ petition for the use of four qualified health claims for selenium and certain forms of cancer, and FDA’s …
By Kurt R. Karst – On August 12th, FDA announced the publication of final regulations concerning “Expanded Access to Investigational Drugs for Treatment Use” and “Charging for Investigational Drugs Under an Investigational New Drug Application.” Both rules will be officially published in the August 13th …
By Carmelina G. Allis – The FDA has issued a Federal Register notice announcing a program that establishes a timeframe for the submission and agency review of responses to Form FDA-483s before the agency’s issuance of Warning Letters. This announcement is in line with our …
By Kurt R. Karst – Earlier this week, Astellas Pharma US, Inc. (“Astellas”) filed a Complaint and an accompanying Memorandum of Points and Authorities in the U.S. District Court for the District of Columbia requesting declaratory and injunctive relief in connection with FDA’s response to a citizen …
By Jamie K. Wolszon & Ricardo Carvajal – FDA has published three draft guidances that instruct growers, packers, processors, transporters, retailers and others on the prevention of microbial hazards in tomatoes, melons, and leafy greens. According to FDA’s press release, Dr. Hamburg stated that the …
FDA Law Blog welcomes back to the blogosphere our friend Scott Hensley, formerly of the Wall Street Journal (where he was the founding editor and a regular contributor to the paper’s Health Blog). Scott will be blogging at the National Public Radio Health Blog and …
By Douglas B. Farquhar – In an August 6, 2009 speech at an event sponsored by the Food and Drug Law Institute, Margaret A. Hamburg, M.D., the new FDA Commissioner, promised to ratchet up enforcement by speeding up issuance of Warning Letters, reducing the amount of time that …
By Kurt R. Karst & Michelle L. Butler – Winston Laboratories, Inc. (“Winston”) recently sued FDA after the Agency denied a waiver of the Prescription Drug User Fee Act (“PDUFA”) application fee assessed with respect to the company’s human drug application (NDA No. 22-403) for …
By Kurt R. Karst – Earlier this week FDA issued several Federal Register notices setting the Fiscal Year (“FY”) 2010 user fee rates for human drugs under the Prescription Drug User Fee Act (“PDUFA”), for medical devices under the Medical Device User Fee and Modernization …
By Alan M. Kirschenbaum – As we reported on August 2, the House Energy and Commerce Committee last Friday reported out its healthcare reform bill, the America’s Affordable Health Choices Act (H.R. 3200). In order to help finance healthcare reform, the bill contains numerous provisions that …
By Kurt R. Karst – Judge Rosemary M. Collyer of the U.S. District Court for the District of Columbia ruled in a 27-page opinion issued last Friday that the 180-day exclusivity forfeiture patent information withdrawal provision at FDC Act § 505(j)(5)(D)(i)(I)(bb)(CC) is not ambiguous and …
By Kurt R. Karst – Last Friday, the House Energy and Commerce Committee favorably reported its version of “America’s Affordable Health Choices Act” (H.R. 3200) by a 31-28 vote after adopting several amendments. A copy of the bill and amendments are available here. Importantly, the …
By Carrie S. Martin – Last Wednesday, the Senate Special Committee on Aging held a hearing to discuss the conflicts of interest presented by the funding of continuing medical education (“CME”) by pharmaceutical and medical device companies. Lewis Morris, Chief Counsel to the Office of …
