Litigation between FDA and Ferring Pharmaceuticals Inc. (“Ferring”) over the availability of 5-year New Chemical Entity (“NCE”) exclusivity for Ferring’s colonoscopy preparation, PREPOPIK (sodium picosulfate, magnesium oxide, and citric acid) for Oral Solution (NDA 202535; approved on July 16, 2012), was recently – and quietly …
There are many things that are unique to the 505(b)(2) NDA approval pathway. Some are good and some are . . . well, let’s just say that they have proven to be frustrating for some 505(b)(2) applicants. Perhaps one of the most nettlesome aspects of …
The U.S. Government Accountability Office (GAO) recently issued a January 2017 report to the Senate Committee on Health, Education, Labor, and Pensions. The GAO report examines: The steps FDA has taken to encourage the development of antibiotics to treat serious or life-threatening infections since the enactment …
Periodically, legislators and others become concerned about reports citing the high price of some orphan drugs, including drugs that achieve blockbuster status (earning more than $1 billion a year). Several proposals have been introduced in response to such concerns. In 1990, Congress passed legislation that …
It was just a couple of weeks ago that we published a post titled “Abuse-Deterrence and 3-Year Exclusivity: FDA Decisions Further Elucidate Scope and a ‘Route of Abuse’ Approach to Exclusivity.” Among other things, we discussed Egalet US, Inc.’s ARYMO ER (morphine sulfate) Extended-release Tablets, …
Questions about the scope of 3-year exclusivity granted by FDA for an abuse-deterrent opioid have been on the rise over the past few years. Initially, FDA was able to punt on some decisions, either because companies exchanged waivers of 3-year exclusivity (e.g., single-entity, extended-release hydrocodone …
It is often said that companies have an absolute right to petition the government to take or not take action without fearing exposure to an antitrust suit. This “right” is thought to be based on a series of Supreme Court decisions that are collectively commonly referred …
Earlier this month, FDA published much-needed draft guidance on 180-day exclusivity, titled “180-Day Exclusivity: Questions and Answers.” We perused the document and promptly posted on it the next day, noting, among other things, that the draft guidance doesn’t reveal anything revolutionary, but rather, provides a …
Earlier this week, Representatives Gus Bilirakis (R-FL) and Kurt Schrader (D-OR) announced the introduction of H.R. 749, the Lower Drug Costs Through Competition Act. The bill, which appears to be nearly identical to H.R. 4784 introduced in March 2016, is intended “to lower the cost …
Last week, just before the new Orange Book (print and electronic versions) made its debut, we opined (see our previous post here) that changes to the Orange Book Preface would likely be made. Now that the print version of the Orange Book is available (here), …
In a Complaint filed on January 27, 2017 in the U.S. District Court for the District of Columbia, ANDA applicant Amneal Pharmaceuticals LLC (“Amneal”) alleges that FDA incorrectly ruled that Amneal forfeited eligibility for 180-day exclusivity for generic versions of NAMENDA XR (memantine HCl) Extended-release …
FDA’s October 6, 2016 Final Rule implementing certain provisions of the December 8, 2003 Medicare Modernization Act (“MMA”), Pub. L. No. 108-173, 117 Stat. 2066, ushered in a lot of changes for NDA and ANDA applicants and sponsors (see our previous post here). The new …
Hardly a day goes by that we don’t see a press release or announcement that a company has requested or received from FDA’s Office of Orphan Products Development (“OOPD”) designation of its drug or biological product as an “orphan drug.” There’s a reason for that: …
On Wednesday, January 25, 2017, a new chapter will begin in the decades-old story of FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (the “Orange Book”). According to a note posted on the Electronic Orange Book website last week (as well as in a separate …
After months of promises and postponements, FDA has finally published its long-awaited draft guidance on biological product interchangeability, Considerations in Demonstrating Interchangeability With a Reference Product, under the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”). While FDA had originally promised the guidance in …
