Drugs

Hogan Lovells Skeptical of New Generics Pilot

A new CDER Office of Generic Drugs pilot program to offer meeting opportunities to ANDA applicants who intend to use model-integrated evidence (MIE) approaches for bioequivalence (BE) determinations is drawing skepticism from some food and drug lawyers. “The use of MIE approaches for BE establishment is increasingly prevalent, particularly in the development of challenging products, such as long-acting injectables, orally inhaled drugs, and topically applied dermatological products,” an agency notice said earlier this month when the pilot was announced. “Industry regularly seeks FDA guidance on best practices for implementing MIE, including common model approaches and addressing complex scientific and regulatory issues.”

According to the agency, the pilot’s primary goal is to foster early and focused interactions between industry and agency reviewers on science-driven topics related to MIE approaches for establishing BE in generic drug development. It will focus the scientific communication on employing quantitative methods and modeling techniques. It is also intended to :

address common issues across multiple products and complex issues for non-complex products that fall outside the scope or focus of current pre-ANDA and ANDA meetings, and
provide a dedicated platform for in-depth discussions on scientific and technical matters related to MIE implementation

In a just-posted client update, lawyers from Hogan Lovells notes that while the MIE approach “remains largely untested,” the overall goal is “geared to reducing reliance on in vivo studies in generic drug development, and to extend the use of in vitro, in silico, and biowaiver options, including the use of model-integrated approach to potentially increase the use of BCS [Biopharmaceutics Classification System] waivers.

“This wider trend is of concern to the extent it reaches beyond the science,” the Hogan Lovells update continues. “Brand manufacturers should be on the lookout for premature changes; for example, new or revised product-specific BE guidances indicating the adoption of these alternate approaches to BE. We continue to cast a critical eye at these alternate approaches, and we intend to closely monitor the potential use of MIE for complex and non-complex generics alike, and to update our innovator clients on potential shortfalls in FDA’s methods and where we see these programs developing.”

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