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“Product Hopping” Antitrust Lawsuit Takes on a Heightened Profile with Proposed FTC Amicus Brief
…the reformulated one. Such conduct can push patients and physicians to abandon the original product. In this way, a brand manufacturer can convert existing market demand for the original product…
Dead Men Tell No Tales . . . and They Don’t Violate the FTC Act, Either
Earlier this year, we blogged on an interesting case out of the District of Delaware, FTC v. Shire ViroPharma, No. 17-cv-00131 (D. Del. Feb. 7, 2017), which called into question…
AstraZeneca’s Challenge to Price Negotiation Fails in Federal District Court
…free from arbitrary and inadequately disclosed governmental constraints” by “directing [CMS] to fix prices at the ‘lowest’ level, without affording adequate procedural safeguards.” Id. at 42. AstraZeneca also alleged that…
FDA Racks Up Another Win in Bioequivalence Litigation; This Time Over Generic EFUDEX
…superficial basal cell carcinomas (“sBCC”) when conventional methods are impractical. As we previously reported, in December 2004, Valeant submitted a citizen petition to FDA requesting that the Agency not approve…
California Court of Appeal Affirms that Methylmercury in Tuna is “Naturally Occurring”
By Riëtte van Laack – In 2004, the State of California sued three tuna companies, Tri-Union Seafoods, LLC, Del Monte Corporation, and Bumble Bee Seafoods, LLC, for violation of California’s…
District Court Decision Sidesteps 30-Month Stay Tolling Issue; Denies Patent Infringement Litigation Stay
…trial court. The agency believes that the trial court should make determinations of cooperation on a case-by-case basis.” FDA also commented, without qualification, that “[u]nder the statute, the reduction or…
Is a Hatch-Waxman 30-Month Stay Terminated if the Dismissal of a Patent Infringement Action is Later Vacated? FDA Says “No”
…a 30-month stay on the approval of NDA 208090. See Purdue Pharma LP et al. v. Colleaium Pharmaceutical Inc., Case 1:15-cv-00260 (D. Del. Mar. 24, 2015); Purdue Pharma L.P. et…
“Sham” Citizen Petition Case Opinion Calls FTC’s Litigation Authority Into Question
…any given case. For example, the FTC cannot seek restitution or disgorgement in administrative litigation (although it can pursue such remedies in federal court after a final administrative order has…
Gottlieb to E-Cigarette Manufacturers: Reduce Youth Use or I Will END You
…address and mitigate widespread use by minors.” FDA provided several plan elements for the manufacturers to consider, which included discontinuing sales to retailers that are subject to an FDA civil…
FDA’s Ninth Annual Report to Congress on 505(q) Citizen Petitions: New Numbers and a New Tone
…or ANDAs were delayed because of a 505(q) petition in this reporting period. The approval of one 505(b)(2) application was delayed because of one 505(q) petition. During FY 2016, FDA…
Congressional Hearing on “Improving Predictability and Transparency in DEA and FDA Regulation” On Monday, April 7th at 3PM; Three Bills Appear on the Agenda
…proceedings should be discontinued or deferred or additional changes need to be made to the corrective plan. Finally, the legislation would also establish the “Combat Prescription Drug Abuse Working Group”…
CDRH’s Plan to De-risk the Medical Device Valley of Death
…scope of the TAP Pilot. Id. All in all, we think the TAP Pilot has the potential to be a valuable program and we applaud the Agency for including performance…
For the Love of Money: The Trump Administration’s Fiscal Year 2018 FDA Budget Plan
…approval and administrative actions can and should pay more to support FDA’s continued capacity. The Fiscal Year 2018 Budget includes $5.1 billion in total resources for FDA, which, with the…
FDA Releases Report on Rare Diseases and Accelerating the Development of Therapies for Pediatric Rare Diseases
…studies and other clinical trials for investigational drugs in PRD population Device strategies Develop expedited approval pathway for certain devices intended to treat unmet medical needs Evaluate the results of…
Days Go By* – Particularly When Responding to an FDA Inspection
…15 business days to address. Regardless of whether the company can complete activities by the time the initial 483 response is due, or simply sets forth its plan for how…