Drugs

FDA Draft Guide on Determining When REMS is Necessary

FDA has released a draft guidance on “FDA’s Application of Statutory Factors in Determining When a REMS Is Necessary” that is intended to clarify how it applies factors in determining whether a risk evaluation and mitigation strategy (REMS) is necessary to ensure that the benefits of a drug outweigh its risks. The agency says the document is one of several being developed to fulfill performance goals it agreed to during the last user fee reauthorization in 2012.

Determining whether a REMS is necessary for a particular drug is a complex, drug-specific inquiry, “reflecting an analysis of multiple, interrelated factors,” the guidance says.“ In conducting this analysis, FDA considers whether (based on premarketing or postmarketing risk assessments) there is a particular risk associated with the use of the drug that, on balance, outweighs its benefits and whether additional interventions beyond FDA-approved labeling are necessary to ensure that the drug’s benefits outweigh its risks,” it says.

FDA’s regulations require it to consider the following six factors in making a decision about whether to require a REMS:

The seriousness of any known or potential adverse events that may be related to the drug and the background incidence of such events in the population likely to use the drug
The expected benefit of the drug with respect to the disease or condition
The seriousness of the disease or condition that is to be treated with the drug
Whether the drug is a new molecular entity
The expected or actualduration of treatment with the drug
The estimated size of the population likely to use the drug

These six factors influence the decisions on whether a REMS is required for a particular drug and what type of REMS might be necessary (i.e., what specific elements/tools should be included as part of the REMS). “No single factor, by itself, is determinative as to whether a REMS is necessary to ensure that the benefits of a drug outweigh its risks,” the guidance 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