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After months of promises and postponements, FDA has finally published its long-awaited draft guidance on biological product interchangeability, Considerations in Demonstrating Interchangeability With a Reference Product, under the Biologics Price Competition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 …
Last January, when FDA issued the Agency’s Calendar Year 2016 Guidance Agenda, we were pretty stoked to seek guidance was planned on various ANDA and Hatch-Waxman issues, including “Three-Year Exclusivity Determinations for Drug Products;” “Submission of ANDAs for Certain Highly Purified Synthetic Peptide Drug Products;” …
Week 52 is often more laid back than any of the other 51 weeks in the calendar year. It offers us a chance to sift through and clean out the office in preparation for yet another busy year. But it’s also a chance for this …
It’s been a couple of months since the dust has settled from FDA’s October 26, 2016 approval of Mylan Pharmaceuticals Inc.’s (“Mylan’s”) ANDA 078276 for a generic version of Daiichi Sankyo Inc.’s (Daiichi’s) BENICAR (medoxomil) Tablets, 5 mg, 20 mg, and 40 mg, so we …
Change is inevitable (cue David Bowie’s “Changes”). Sometimes change occurs slowly and goes (largely) unnoticed, and sometimes it comes fast and unexpected. Sometimes change is good, and sometimes it’s not. Change should not be confused with progress, growth or retreat, which are not inevitable, but …
We’ve previously posted some summaries of the 21st Century Cures Act (Cures Act), which the President signed into law on December 13, 2016 (Public Law No. 114-255). (Those summaries are available here, here, and here.) This post focuses on only one section of the new …
Way back in June 2016, the United States Supreme Court invited the Solicitor General to file a brief in two cases – Docket No. 15-1039 and Docket No. 15-1195 – expressing the views of the United States as to two provisions of the Biologics Price …
By Kurt R. Karst, John R. Fleder & Robert A. Dormer – The current FDA system to announce hotly contested generic drug approval decisions is broken. As we see it, FDA’s “system” pleases no one and does not appear to be legally mandated. Moreover, whatever advantage …
It’s been nearly 30 years since President Ronald Reagan, on September 24, 1984, held a ceremony in the Rose Garden to sign into law the Drug Price Competition and Patent Term Restoration Act of 1984, Pub. L. No. 98-417, 98 Stat. 1585 (1984) – better …
An article published by Law360 and co-authored by H. Keeto Sabharwal and Dennies Varughese of Sterne Kessler Goldstein & Fox PLLC, and Kurt R. Karst of Hyman Phelps & McNamara PC, examines whether, and to what extent, a successful Inter Partes Review (“IPR”) challenge by a …
By Kurt R. Karst – On July 19th, President Obama announced his intent to nominate Maureen K. Ohlhausen as a Commissioner of the Federal Trade Commission (“FTC”). Ms. Ohlhausen is currently a partner at Wilkinson Barker Knauer LLP, where she specializes in privacy, data protection, and …
Recently, we were perusing FDA-TRACK (Transparency, Results, Accountability, Credibility, Knowledge-sharing), FDA’s “web-based tool for tracking progress on key activities throughout the agency and making the information available both internally and to external stakeholders and the public,” and the FDA-TRACK Health Care Reform Dashboard in particular, …
