On January 23rd, BioCentury This Week TV will broadcast a program concerning the latest thinking about how to create a sustainable economic model for both orphan drug developers and payers. The program, titled “The Economics of Orphan Drugs – Why Successful Cures Bring Challenges for …
By Kurt R. Karst – Following the submission of two letters to FDA from both members of the U.S. House of Representatives and the U.S. Senate (see our previous posts here and here) critical of the Agency’s recent characterization of the 12-year reference product exclusivity period …
By Jeffrey K. Shapiro – Yesterday FDA announced that the Center for Devices and Radiological Health (“CDRH”) intends to take 25 actions to improve the 510(k) program in 2011. The full action plan and remarks from CDRH Center Director Jeffrey Shuren, M.D., J.D. can be accessed …
By Kurt R. Karst – In an unpublished, and subsequently sealed, decision handed down earlier this week by Chief Judge Garrett Brown, Jr. of the U.S. District Court for the District of New Jersey, the court dismissed without prejudice an Amended Complaint filed by Paddock Laboratories, …
By William T. Koustas – We previously reported on the struggle between FDA and Regenerative Sciences, Inc. (“Regenerative”) in which Regenerative challenged FDA’s claim that the company’s stem cell procedure is subject to FDA jurisdiction and regulation under the Federal Food, Drug, and Cosmetic Act (“FDCA”) …
By Kurt R. Karst – On January 18th, the U.S. Supreme Court denied Apotex Inc.’s Petition for Writ of Certiorari asking for a review of the U.S. Court of Appeals for the District of Columbia Circuit’s decision involving Teva’s 180-day exclusivity for generic versions of Merck’s …
By Kurt R. Karst – In a Complaint for Declaratory Judgment filed in the U.S. District Court for the Eastern District of Michigan (Southern Division) last week by Apotex Inc., the company is trying to trigger 180-day exclusivity for generic LEXAPRO Tablets. Apotex heavily relies on …
By Susan J. Matthees – FDA is announcing that it is taking steps to reduce the maximum dosage strength of acetaminophen in prescription combination products to 325 mg in a single dosage unit. The Agency will also require safety labeling changes, including a boxed warning, for …
By Ricardo Carvajal & Wes Siegner – As we would wager is true of all major pieces of legislation, the Food Safety Modernization Act (“FSMA”) can be expected to have significant unanticipated consequences. By way of background, the FSMA requires all food facilities subject to registration …
By Riëtte van Laack – As previously reported here, on Dec. 8, 2010, FDA issued a proposed rule to amend the interim final rule (“IFR”) for the phytosterol health claim. In the preamble to that proposal, the agency stated its intent to discontinue its policy of …
By Kurt R. Karst – In a Complaint lodged against the U.S. Patent and Trademark Office (“PTO”) in the U.S. District Court for the Eastern District of Virginia last September, but only recently served, the Genetics & IVF Institute (“GIVF”) is challenging the PTO’s August 2010 …
Hyman, Phelps & McNamara, P.C.'s Jeff Shapiro published an article in this month's MD&DI magazine - What Happens to Medical Device Reports Once They Reach FDA? In the article, he summarizes a Office of Inspector General Report finding that FDA has not used medical device reporting …
By Ricardo Carvajal – The American Bar Association’s Section of Ligation (specifically the Food and Supplements Subcommittee of the Products Liability Committee) is presenting its First Annual Workshop on Food and Supplements on February 17 in Atlanta. Hyman, Phelps & McNamara, P.C.’s Ricardo Carvajal will be …
By Kurt R. Karst – In a January 7th letter sent to FDA Commissioner Margaret Hamburg, a group of four U.S. Senators take exception to FDA’s recent characterization of the 12-year exclusivity period provided by the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”) as …
By David B. Clissold – Last week, FDA released Agency's first guidance for tobacco product manufacturers concerning the introduction of “new” tobacco products. The guidance was issued in final form since some manufacturers will need it to help them submit reports to FDA over the next few months. A “new …
