On June 4, 2018, FDA posted a statement from CDER Director Janet Woodcock announcing a multi-pronged FDA initiative to modernize FDA’s drug review offices and processes. The initiative will involve: Staffing increases Increasing the number of review offices from the current 5 to 9 and the review …
More than 10 years after the enactment of FDC Act § 505(q), titled “Petitions and Civil Actions Regarding Approval of Certain Applications,” interest in citizen petitions remains high. Each year we see several analyses of the effects of citizen petitions on generic competition, as well as …
FDA announced last week its newest initiative to address alleged “gaming” tactics that FDA believes are used to circumvent the delicate balance of innovation and competition set forth by Congress in the Hatch-Waxman Act. As part of FDA’s Drug Competition Action Plan, FDA has published …
On May 16, 2018, Vermont Governor Phil Scott signed Senate Bill 175, which allows for the wholesale importation of prescription drugs from Canada into Vermont. The new law directs the Vermont Agency of Human Services (VAHS) to design a wholesale prescription drug importation program that …
We have the technology. It will definitely cost more than six million dollars, and there are questions about whether it will be better than it was before. But Dr. Sarfaraz Niazi thinks he can rebuild the biosimilar approval process to make it more efficient. In an …
On May 15th, FDA published in the Federal Register a proposal to amend the product jurisdiction regulation (21 C.F.R. Part 3). This proposal seeks to update, clarify, and streamline the product classification and designation process. However, the proposal fails to address some significant flaws in …
Last week, the Superior Court of Pennsylvania struck a blow to Appellant Joseph Caltagirone’s wrongful death and survival claims against drug manufacturers Cephalon, Inc. and Teva Pharmaceuticals, USA, Inc. The Superior Court’s non-precedential decision relied on federal preemption principles to affirm the trial court’s dismissal …
The U.S. Food and Drug Administration, in two complaints (here and here) filed last week in federal court, is seeking permanent injunctions to prevent two stem cell clinics from marketing stem cell products without FDA approval. Specifically, a permanent injunction is being sought against US Stem …
Notwithstanding a statutory deadline of two years after the enactment of the 2013 Drug Supply Chain Security Act (“DSCSA”), FDA has finally published a draft guidance document on waivers, exceptions, and exemptions (“WEE”) from certain requirements of FDCA Section 582. Since late November 2013, the pharmaceutical …
Late last month, CDER’s Office of Pharmaceutical Quality (OPQ) published a MAPP (Manual of Policies and Procedures #5310.3) outlining its policy for granting or denying expedited reviews of NDA and BLA Prior Approval Supplements (PAS) that involve chemistry, manufacturing and controls (CMC) changes overseen by …
On April 27, 2018, Petitioners Breckenridge Pharmaceutical, Inc. and Nexgen Pharma, Inc. filed a Petition for Review in the United States Court of Appeals for the District of Columbia Circuit. The Petition seeks review of a final FDA order published in the Federal Register on …
Declaring its intent to stand on the original complaint in FTC v. Shire ViroPharma, the FTC has appealed the District Court for the District of Delaware’s decision to dismiss the Commission’s unfair competition case against Shire without prejudice. We previously blogged about this case here, …
Last year, the President signed into law the Food and Drug Administration Reauthorization Act (FDARA) to revise and extend the user fee programs for drugs, medical devices and biosimilar biological products. Section 902 of FDARA requires FDA to publicly report, annually, information related to inspections …
On Friday, April 13, 2018, the U.S. Court of Appeals for the Fourth Circuit ruled that Maryland’s law prohibiting “price gouging” by generic pharmaceutical manufacturers (HB 631) is unconstitutional because it violates the dormant commerce clause by directly regulating transactions that occur outside of Maryland. …
As folks know by now, each month we pore over the latest Orange Book Cumulative Supplement in an effort to keep our popular 180-Day Exclusivity Tracker as current as possible, and to look for interesting precedents. One recent entry in particular caught our attention. It …
