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Regulatory Focus™ > News Articles > FDA, EMA and PMDA Seek Antimicrobial Clinical Study Regulation Harmonization

FDA, EMA and PMDA Seek Antimicrobial Clinical Study Regulation Harmonization

Posted 26 May 2017 | By Zachary Brennan 

For the second time in seven months, the European Medicines Agency (EMA), the US Food and Drug Administration (FDA) and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) met in late April to discuss their approaches for evaluating antimicrobial agents, with the aim of identifying areas for convergence.

Antimicrobial resistance has been recognized as a public health threat. The World Health Organization said it is "so serious that it threatens the achievements of modern healthcare," while Janet Woodcock, director of FDA's Center for Drug Evaluation and Research (CDER) said last June that current incentives are not enough to overcome the challenges of developing new treatments.

In 2015, FDA approved Allergan's Avycaz (ceftazidime-avibactam) to treat adults with complicated intra-abdominal infections, among others. This was the fifth approved antibacterial drug designated as a Qualified Infectious Disease Product (QIDP), which was part of the GAIN Act, passed in an attempt to incentivize the development of new antibiotics and which provides companies with an additional five years of market exclusivity if they develop an antibiotic intended for a qualified infectious disease.

But the US Government Accountability Office noted in March that although FDA has approved more than 100 QIDP requests between 2012 and 2015 (or about 90% of the total requests made), only six of those drugs have been approved. The CDC said back in 2013 that the development of new antibiotics has been getting progressively more difficult over the last few decades.



But Dr. Aaron Kesselheim, an associate professor at Harvard Medical School and Director of the Program on Regulation, Therapeutics and Law, pointed Focus to an article he co-wrote that noted that "after adjusting for drugs subsequently withdrawn, the record for antibiotic innovation is less dire than previously reported." The article also says future policies for antibiotic incentives "should not be based on simple numerical targets and key provisions should ensure appropriate quality as well as quantity of antibiotic drug innovation."

Second Tripartite

This week, EMA discussed the agencies' latest agreement that they could harmonize some regulatory requirements for clinical studies for specific types of infections, such as urinary and intra-abdominal infections.

The regulators also "discussed and defined pathways agreeable by the three agencies for the development of new antibacterial agents addressing unmet needs related resulting from antimicrobial resistance."

In the first meeting in London in September 2016, the three also noted the appropriateness of exercising flexibility with clinical development requirements for antibacterial agents, especially for new ones, the benefit of further convergence on the data requirements, the importance of conducting sound analyses of the pharmacokinetic-pharmacodynamic relationship to better select dosing regimens for study in clinical trials and the value in developing trial networks.

Further discussions will likely be held in October 2017.

FDA-EMA Pediatric Collaboration

The development of pediatric drugs is another area of cross-border concern. In 2007, EMA and FDA established monthly teleconferences to discuss product-specific pediatric development and other topics as part of what's known as their  Pediatric Cluster.

Recently, industry groups presented four options to EMA on ways to facilitate engagement with FDA to better facilitate global development programs. Industry presented four options with the varying challenges and opportunities for each:

  1. Parallel EMA/FDA scientific advice including pediatric experts
  2. Joint pre-submission meeting with scientific discussion
  3. Enhanced common commentary during EMA's pediatric investigation plan (PIP) and FDA's pediatric study plan (PSP) processes
  4. Mutual reliance on pediatric plan assessments

In September 2016, EMA and FDA also set up a new cluster on rare diseases.


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