Prescription Drugs and Biologics

Over the course of roughly the last year, gene editing has gone from being a topic limited to scientific conferences to being featured in the New York Times and on the cover of TIME magazine.  Most of the attention has been due to a molecular …

By Anne K. Walsh & Andrew J. Hull – FDA announced in an August 31, 2016 notification (“Notification”) that it will convene a public hearing to address its authority to regulate communications regarding unapproved uses of approved or cleared drugs and medical devices. The public hearing …

By Kurt R. Karst –       Orange Book aficionados may have noticed an interesting entry that recently appeared as an addition to the Orange Book. It came out earlier this month with FDA’s publication of the July 2016 Orange Book Cumulative Supplement (page 1-2C), and also with …

By Kurt R. Karst –        Q. Why did the chicken cross the road?A. To get to the other side. Q. Why did the turtle cross the road?A. To get to the shell station. Q. Why did the duck cross the road?A. To prove he wasn’t chicken! Q. Why did …

By Kurt R. Karst –   Last month, while this blogger was on vacation enjoying the fine beers of Germany during a tour of that country, the U.S. District Court for the District of Columbia issued a Memorandum Opinion in a rather interesting Hatch-Waxman Patent Term Extension …

  In recent years, the level of scrutiny on foreign pharmaceutical manufacturing facilities in countries like China and India has skyrocketed—along with the demand and dependence of western countries on the supply of goods coming from those facilities. Furthermore, increased enforcement aimed at the medical …

By Kurt R. Karst –       In a Per Curiam Judgment handed down last month, the U.S. Court of Appeals for the District of Columbia Circuit affirmed District Court Judge Ketanji Brown Jackson’s January 2015 ruling upholding FDA’s September 26, 2014 approval of a 505(b)(2) application (NDA …

By Jay W. Cormier – As readers of this blog may recall, FDA observed remarkable conditions at two facilities on the NIH campus in Bethesda, MD (see our post here).  Then, earlier this year, NIH stated again that it was closing its drug manufacturing facilities (see …

By Karla L. Palmer – FDA announced last week the availability of a draft guidance document titled, “Insanitary Conditions at Compounding Facilities.”  This draft is FDA’s first attempt to assist compounding facilities and state regulators in identifying “insanitary conditions so they can implement appropriate corrective actions.” …

A breakthrough paper by Hyman, Phelps & McNamara, P.C’s Frank Sasinowski and Alexander Varond concerning FDA’s Subpart H approvals has just published in the Food and Drug Law Journal. Titled “FDA’s Flexibility in Subpart H Approvals: Assessing Quantum of Effectiveness Evidence,” the paper examines the …

By Kurt R. Karst – Like the Running of the Bulls in Pamplona, Spain each Summer, we wait with bated breath each July and August to see how FDA-regulated companies might get gored when FDA releases the user fee rates for the next fiscal year. Over …

By Kurt R. Karst –       Late last week, Judge Ketanji Brown Jackson of the U.S. District Court for the District of Columbia issued a 57-page Memorandum Opinion handing FDA a victory on the scope of 3-year new clinical investigation exclusivity. The decision came in a case …

By Kurt R. Karst –       We recently posted on an orphan drug clinical superiority precedent we came across: PURIXAN (mercaptopurine) Oral Suspension, 20 mg/mL, for the treatment of Acute Lymphoblastic Leukemia in pediatric patients. It’s the sixth “greater safety” orphan drug clincial superiority precedent we know …

by Alan Kirschenbaum and Michelle Butler On July 14, 2016, CMS issued a release to manufacturers regarding value-based purchasing (VBP) arrangements.  The purpose of the release is to (1) inform manufacturers how to seek guidance from CMS regarding the impact such arrangements might have on the …

By Karla L. Palmer FDA published for comment two non-binding draft guidance documents addressing compounding of commercially available drug products by traditional pharmacies under FDCA Section 503A and outsourcing facilities under Section 503B.  [Section 503A Draft Guidance is HERE, blogged separately] and Section 503B Guidance is …