On Tuesday, February 19, 2019, FDA released its first Final Rule (of many likely to follow…) identifying six substances that FDA has determined are appropriate for use in compounding by Section 503A pharmacies. The Final Rule relates back to FDA’s 2016 Proposed Rule nominating certain …
After months of ever expanding drug recalls, and multiple investigative reports by different media outlets calling into question the safety of the U.S. generic drug supply (see, for example, “America’s Love Affair with Cheap Drugs has a Hidden Cost,” “How a Tainted Heart Drug Made …
They could have taken a middle ground, given the unique facts of FTC v. Shire ViroPharma — but instead the Third Circuit went whole hog with a decision that, if it stands, could set the FTC’s litigation authority back decades. In this case, bad facts …
As difficult as it might be to believe, its true. In fact, last week, the FDA Commissioner, Dr. Scott Gottlieb, and the CBER Center Director, Dr. Peter Marks, issued a press release cautioning consumers against receiving “young donor plasma infusions” that are promoted as unproven …
The United States Department of Justice (“DOJ”) announced on February 8, 2019, the use of a new weapon in its enforcement arsenal to help manage the opioid crisis. It involved a coordinated effort including DOJ’s Prescription Interdiction & Litigation (“PIL”) Task Force, which deploys all …
As avowed dog-lovers and FDA law enthusiasts, a recent Complaint filed in the District Court of D.C. caught our attention. Vanda Pharmaceuticals filed a Complaint on February 6, 2019 alleging that FDA’s insistence that Vanda perform a 9-month dog study with its drug candidate tradipitant …
With a little over a year under FDA’s belt implementing its Comprehensive Regenerative Medicine Policy Framework (which we blogged about here), CBER has updated its current thinking with the issuance of final versions of the two Regenerative Medicine Advanced Therapy (“RMAT”)-related guidance documents: Expedited Programs for …
Yeah, you know me. Given Commissioner Gottlieb’s clear proclivity for blog posts with song titles rather than Orange Book puns, we’ll stick with those for a while. We just hope the Commissioner likes early 1990s rap as much as he likes rock from the 1970s …
FDA released its annual Report to Congress on 505(q) Citizen Petitions last week – the Tenth Annual Report to Congress on Delays in Approvals of Applications Related to Citizen Petitions and Petitions for Stay of Agency Action for Fiscal Year 2017. The Report, which is …
In yet another step to address drug pricing, Commissioner Gottlieb announced last week several new initiatives, including an update to the revered Orange Book. Cue the crazy Muppet arms! Proclaiming the Orange Book update a “transparency initiative,” FDA expects that this undertaking will “provide greater …
Over the 12 years that we’ve been doing this blogging gig, we’ve never before drawn inspiration for a post from Lebowski Pony – a.k.a. “the Dude” – that iconic character from the 1998 film The Big Lebowski, written and directed by Joel and Ethan Coen. …
Hyman, Phelps & McNamara, P.C. is pleased to announce that Anne Walsh will present at this year’s Pharmacovigilance & Drug Safety: Risk Management & Regulatory Compliance Conference, to be held in Arlington, VA on March 12-13, 2019. The focus of her presentation is on post-market …
As we await our nation’s State of the Union address, FDA’s own Commissioner Scott Gottlieb and Center for Biologics Evaluation and Research (CBER) Director Peter Marks issued a joint statement providing a state of union of sorts on the development and regulation of cell and …
In one of the multiple lawsuits that Pharmaceutical Manufacturing Research Services (PMRS) has filed against the FDA related to the approval of abuse-deterrent opioids in the last few years, the Eastern District of Pennsylvania summarily rejected PMRS’s bid to keep abuse-deterrent opioid, RoxyBond, off the …
CBI is holding its Fourth Edition Drug Pricing Transparency Congress on March 25-26, 2019 in Philadelphia, Pennsylvania. This program convenes stakeholders to discuss how the future of drug pricing transparency regulations will impact commercialization, reimbursement, pricing, and compliance practices. Given the novelty and complexity of …
