By Kurt R. Karst – It’s been a little more than 2.5 years since Section 505(w) was added to the FDC Act by Section 1134 of the 2012 FDA Safety and Innovation Act (“FDASIA”). Section 505(w), titled “Deadline For Determination on Certain Petitions,” requires FDA to …
By Anne K. Walsh – This post relates to the all-important package insert, which provides health care professionals with the latest information about the approved uses of a prescription drug or biological product, as well as information necessary for the safe and effective use of the …
By Kurt R. Karst – When Judge Ketanji Brown Jackson of the U.S. District Court for the District of Columbia noted in a January 12, 2015 Minute Order that the Court filed under seal a “lengthy opinion” on January 9, 2015 denying Motions for Summary Judgment …
By Kurt R. Karst – The news came down on Thursday that FDA’s Center for Drug Evaluation and Research Director Janet Woodcock, M.D., named Kathleen “Cook” Uhl, M.D., as the permanent director of the Office of Generic Drugs (“OGD”). Although Dr. Uhl has manned the helm at OGD …
By John R. Fleder – Lawyers are often asked if a client can be sued if the client does something. Almost without exception, the answer is yes. It does not take much for a person to file a lawsuit in court without much or any evidence, …
By Kurt R. Karst – A little over three months ago, we on a Complaint and a Motion for Temporary Restraining Order and Preliminary Injunction Takeda Pharmaceuticals U.S.A., Inc.’s (“Takeda”) filed against FDA in the U.S. District Court for the District of Columbia challenging the …
By James C. Shehan – FDA’s Oncologic Drugs Advisory Committee unanimously voted in favor of approval of EP2006, Novartis’s biosimilar version of Amgen’s Neupogen® (filgrastim) for all five of the indications for which Neupogen is approved. This ground-breaking event manages to both move the US a …
By Kurt R. Karst – Late last month, the Pharmaceutical Research and Manufacturers of America (“PhRMA”), the Biotechnology Industry Organization (“BIO”), and the Generic Pharmaceutical Association (“GPhA”) jointly filed a Petition for a Writ of Certiorari (Case No. 14-751) with the U.S. Supreme Court asking the …
By Kurt R. Karst – It’s been many months since we last posted on the issue of so-called “premature notice” (and over a year since we first posted on the issue). Premature notice is notice – ineffective notice – of a Paragraph IV certification sent to …
By Kurt R. Karst – In what is, to our knowledge, a first-of-its-kind written decision, Judge Esther Salas of the U.S. District Court for the District of New Jersey issued an Oral Opinion and Order on December 22, 2014 granting without prejudice in part and denying …
By Kurt R. Karst – Last week, the Federal Trade Commission (“FTC”) announced the issuance of the Bureau of Competition’s annual summary of agreements filed with the Commission during the last fiscal year (Fiscal Year 2013) – Agreements Filed with the Federal Trade Commission under the …
By Anne Marie Murphy – On December 24th, in response to industry requests, FDA issued a guidance document indicating that it will not enforce product tracing requirements of the Drug Supply Chain Security Act ("DSCSA") prior to May 2015. The guidance, states in relevant part: FDA recognizes that …
By Kurt R. Karst & Michelle L. Butler – Ever since FDA withdrew a notice of appeal in Depomed Inc. v. U.S. Department of Health and Human Services et al., Case No. 1:12-cv-01592, to the U.S. Court of Appeals for the District of Columbia Circuit (see …
By Kurt R. Karst – Queue up the dueling banjo scene from the film Deliverance. . . . Early last month we saw an interesting press release from Veloxis Pharmaceuticals, Inc. (“Veloxis”) announcing FDA’s October 30, 2014 tentative approval of the company’s 505(b)(2) NDA 206406 for ENVARSUS …
By James E. Valentine* & Anne Marie Murphy – As we previously reported, last month the National Institutes of Health (“NIH”) published a Notice of Proposed Rulemaking on clinical trials registration and results submission (“NPRM”), and is requesting public comment by February 19, 2015. The NPRM generally …
