EIRs/483s

Attorneys Dismiss ‘Hype’ on FDORA Animal Testing Provision

Don’t hold your breath thinking FDA will soon eliminate preclinical animal testing and allow other data forms like in vitro or in silico or some other kind of modeling data to support pre-clinical data requirements after the recent Food and Drug Omnibus Reform Act (FDORA) gave the agency more latitude to allow this in certain instances. That’s the conclusion of Hyman Phelps & McNamara attorneys Mark Tobolowsky and Charles Raver writing in an online FDALawBlog post. They say the FDORA change on preclinical animal data may not be as “monumental” as some believe, and that it is mostly “symbolic” and likely to take “many years before we see it have a measurable impact. In effect, the revisions to the FD&C Act and the PHS Act are designed to encourage the use of alternatives to animal testing not eliminate animal testing in drug development.”

The attorneys note that the former statutory language did not mandate animal testing. “Rather, the provisions did, and still do, leave it up to FDA’s discretion what methods and tests are most appropriate under the circumstances,” they write. “In our experience, FDA is inherently an empirically driven body of scientists, physicians, and policy-makers. It will likely take time to supplant decades of reliance upon existing animal testing methods used to investigate drug pharmacology and toxicology. Alternative methods will require significant research investment to demonstrate their utility for a particular context of use and inform regulatory decision-making.”

The post also acknowledges FDA efforts dating back to 2017 to consider alternative methods, such as its Predictive Toxicology Roadmap and an agency-wide Alternative Methods Working Group that looked at alternative methods going beyond just toxicology research. “Ultimately, regardless of any changes made by FDORA, it will be up to the science surrounding new alternative methods, and FDA’s acceptance of the evidence base to support them, to demonstrate the suitability of these alternative tests as replacements for animal testing,” the attorneys conclude.

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