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FDA's Antibacterial Task Force Takes Shape, Seeks Ideas on How to Support New Guidance, Paradigms

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By Alexander Gaffney, RF News Editor

US regulators are once again reaching out to members of industry, this time seeking input on how the US Food and Drug Administration (FDA) facilitates the development of new antibiotics, and whether it could be doing more to help the pharmaceutical industry stay ahead of rising rates of antibiotic resistance.

Background

"Antibacterial drug development is critical to the public health and is an FDA priority," FDA explains in a new Federal Register posting. "We recognize the mounting concern that antibacterial drug development has not kept pace with the increasing threat of drug-resistant and untreatable infections."

Those same concerns have led to a flurry of activity in recent months, both on the part of regulators and legislators alike.

In 2012, for example, FDA proposed restricting the use of many antibiotics in animals on a voluntary basis, and also said it would soon require sponsors of those drugs to submit detailed reports regarding the sale, distribution and use of antibiotic products. And in January 2013, FDA proposed the launch of a new approval pathway which FDA stipulated could be used to support the development of products used to treat antibiotic-resistant bacteria.

But the biggest changes of all were spurred by legislators, who in 2012 passed the FDA Safety and Innovation Act (FDASIA), which contained the Generating Antibiotic Incentives Now (GAIN) Act, intended to spur the development of new antibiotic therapies by giving them new market-based incentives like five years of additional market exclusivity and new review resources to decrease FDA review times.

A Task Force

In September 2012, FDA set up an internal task force to assess the hurdles industry faces when developing antibiotics. In a statement, the agency said the 19-member task force, known as the Antibacterial Drug Development Task Force, would be focused on four main issues:

  • exploring regulatory issues associated with the use of clinical pharmacology data and other statistics, as well as the use of innovative clinical trial designs and new methods of evaluation
  • the identification of unmet medical needs for antibacterial drugs and ways to enhance upstream development and research
  • re-examining existing guidance documents and regulations to determine if the existing regulatory structure is accommodating the development of new antibiotic treatments and, if not, where clarification or changes are needed
  • the use of new, cross-cutting agreements between FDA and other third parties, such as think tanks, to broaden the pool of ideas the agency is considering

FDA officials said the end goal of the project is to promote a paradigm shift in how the agency receives, reviews and approves new antibacterial products. “Our hope is that this effort will result in important new breakthroughs in the field of antibacterial drug development and help in the fight against antibiotic resistance," Rachel Sherman, associate director of medical policy for CDER, said.

New Developments for the Task Force

Until now, however, the efforts of that task force have been fairly low-key. The 19 members, which include Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER), and Bob Temple, deputy center director for Clinical Science at CDER, is composed entirely of FDA regulators and has only met a handful of times since its inception.

But the task force's profile may be about to change. In a Federal Register posting on 30 May 2013, FDA said the task force is—for the first time—seeking public input regarding "new clinical development paradigms for antibacterial drugs."

In particular, FDA said it is exploring a range of new approaches to drug development: Bayesian analysis, adaptive trials, use of care diagnostics, large simple trials, and the use of surrogate endpoints to support accelerated approval.

Regulators said input on novel study designs would be welcome from industry. "To advance the development of antibacterial drugs, we seek input on the listed examples as well as additional ideas regarding the design, conduct, and analysis of clinical trials," FDA added.

That development will also reportedly take the form of a new guidance document or documents meant to "Address issues related to development of new antibacterial drugs." Those guidance areas will be focused on specific diseases and infections, and regulators said they wanted input on which areas could stand to benefit most from development of new guidance or clarification of existing guidance.

Comments are due by 31 July 2013.


FDA: New Approaches to Antibacterial Drug Development




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