Drugs

GPhA Backs Bill to Curb REMS Abuse

The Generic Pharmaceutical Association (GPhA) says it supports the bipartisan Creating and Restoring Equal Access to Equivalent Samples (CREATES) act introduced by Sen. Chuck Grassley (R-IA). An association statement says the bill “improves patient access to safe and affordable medicines by taking steps to curb abuses of Risk Evaluation and Mitigation Strategies (REMS) without compromising patient safety.”

The statement says that some drug companies misuse REMS to block competition from generic medicines. It says that REMS abuse can occur in two scenarios. First, branded drug companies can cite a REMS as a reason to refuse to sell samples of their product to potential generic competitors, which prevents the generic company from conducting bioequivalence tests needed for FDA approval. The second scenario is when a branded drug company intentionally prevents generic competitors from joining a “shared REMS,” effectively keeping generic competition off the market even when the innovator drug patent has expired.

GPhA says CREATES addresses the two scenarios by authorizing a judge to award damages to deter future misconduct. The bill, it says, allows a generic drug manufacturer to bring an action in federal court to obtain the sample it needs, authorizes a judge to award damages to deter future misconduct, and allows brands and generics to enter court-supervised negotiations for establishing shared safety protocols. The bill also helps deter misuse among brand manufacturers with self-imposed (not required by FDA) REMS-like restrictions on the sale or distribution of products, GPhA says.

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