Drugs

Abandon FDA Biologic Naming Plan: FTC

The Federal Trade Commission (FTC) has reiterated its opposition to an FDA proposed convention for naming non-proprietary biological products, saying the plan’s “disparate treatment and differentiated naming of certain biosimilar products will reduce biosimilar competition in the U.S.” FTC called on FDA to abandon its proposal to add a unique, meaningless suffix to the nonproprietary name of all biosimilar and interchangeable products and to any reference product approved after 1/2017.

The FTC comment letter submitted in response to an updated FDA draft guidance, reiterates concerns raised in its previous comments about the effect on competition. “We noted that the use of these meaningless suffixes might limit entry of new competitors (or weaken competition from new entrants) because new competitors would incur additional costs to overcome any (mis)perception of quality difference and suitability for biosimilar products that might be implied by the naming convention,” FTC said.

The letter says the FDA updated guidance raises additional concerns by recommending use of the suffixes only for (1) the nonproprietary names of reference biologic products that FDA approved after 1/2017; and (2) all biosimilar and interchangeable products. “This would create two classes of biological products…,” FTC argued. “This unusual naming convention, applied exclusively to a subset of new entrants, likely would create consumer confusion and discourage use of newly introduced biosimilar and interchangeable products. Inconsistency of naming practices may thus diminish future competition.”

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