Drugs

‘Industry-wide Dance’ Shapes BPCIA Framework: Attorneys

Patterson Belknap attorneys say that a number of court decisions since the 2010 enactment of the Biologics Price Competition and Innovation Act (BPCIA) have laid out the basic framework for implementation of the act, at least until the next series of disputes is litigated. Writing in an online post, the attorneys say that “just as the BPCIA’s procedures are known as a ‘patent dance’ between the biosimilar applicant and the innovator, the development of the case law can be seen as an industry-wide dance, with biosimilar applicants and innovators each moving in unison to take consistent, but diametrically opposed, positions on a series of fundamental issues concerning the operation of the statute.”

The post reviews four issues that have been adjudicated: rejection of pre-application declaratory judgment actions, determination that the patent dance is optional, determination that the 180-day marketing notice period does not begin until FDA has approved a biosimilar, and determination that the 180-day notice period is mandatory.

“Through resolution of these disputes the basic framework for BPCIA patent litigation has taken shape,” the post concludes. “Although more disputes will undoubtedly arise in the future, particularly as biosimilar applicants begin to challenge newer biologics that are still protected by the statutory 12-year exclusivity period, the fundamental questions about the operation of the statute are well on their way to being resolved.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome