Drugs

GPhA Urges Denial of AbbVie Petition on Interchangeability

The Generic Pharmaceutical Association (GPhA) says that FDA should deny a 12/16/15 AbbVie petition asking the agency to require specific criteria before designating any product as an interchangeable biologic. AbbVie had called on FDA to require:

that interchangeability be established in each condition of use for which the reference product is licensed, regardless of whether the applicant intends to label its product for every such condition of use;

clarification that the statutory standards for interchangeability differ in both kind and scope from the standard for establishing biosimilarity; and

convening a Part 15 hearing to obtain public input on the topic and only subsequently issue guidance or regulations addressing interchangeability.

In comments submitted in opposition to the petition, GPhA argues that AbbVie’s petition “seeks to impede the development and approval of interchangeable biological products by asking FDA to impose overly-stringent, standards to establish interchangeability that are neither required by the statutory language nor justified by sound science.” The group says that granting the petition’s requests would lead to significant disincentives to the development of interchangeable biologics and “impair patient access to affordable alternatives to brand name biologics, contrary to Congressional intent.” Additionally, GPhA says that convening a Part 15 meeting is unnecessary and would delay issuance of guidance on interchangeability until after this meeting so that feedback from the meeting could be considered.

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