By Kurt R. Karst – Reports FDA submitted to Congress on the Agency’s implementation of FDC Act § 505(q) recently became available and show that only a few applications have been delayed by certain citizen petitions covered by the law, and that the Agency is timely …
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By Kurt R. Karst – In an unpublished, and subsequently sealed, decision handed down earlier this week by Chief Judge Garrett Brown, Jr.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 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 …
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 Kurt R. Karst – Last Friday, 32 State Attorneys General filed an amicus brief with the U.S. Supreme Court asking the Court to grant the Petition for Writ of Certiorari filed last month by a group of drug purchasers in Louisiana Wholesale Drug Co., Inc., …
By Susan J. Matthees – Last week, FDA announced that the Agency has adopted final amended informed consent regulations. As we noted last year, the Food and Drug Administration Amendments Act ("FDAAA") § 801(b)(3)(A) required that FDA amend the informed consent regulations set forth at 21 C.F.R. § …
By Kurt R. Karst – In a notice slated for publication in the January 7th Federal Register, FDA is seeking to end the continued marketing of many unapproved oral prescription drugs for the relief of cough, cold, or allergy. The action will likely affect hundreds of …
By Kurt R. Karst – In a letter recently submitted to FDA by the three principal authors of the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”) – Representatives Anna Eshoo (D-CA), Jay Inslee (D-WA), and Joe Barton (R-TX) – the legislators take issue with …
By Kurt R. Karst – Amphastar Pharmaceuticals Inc. (“Amphastar”) has filed with the U.S. District Court for the District of Columbia an Amended Complaint for Declaratory and Injunctive Relief against FDA in Amphastar’s continuing battle to win approval of the company’s long-pending Abbreviated New Drug Application …
By Kurt R. Karst – Another week, another Petition for Writ of Certiorari filed with the U.S. Supreme Court on an issue involving the drug industry. The latest petition comes from Caraco Pharmaceutical Laboratories, Ltd. (“Caraco”) and Sun Pharmaceutical Laboratories, Ltd. (“Sun”) and requests the Court’s …
