FDA, EMA, PMDA Begin Push for New Antibacterials

Regulatory NewsRegulatory News
| 08 September 2016 | By Michael Mezher 

The US Food and Drug Administration (FDA), European Medicines Agency (EMA) and Japan's Pharmaceuticals and Medical Devices Agency (PMDA) met at EMA headquarters in London last week to discuss their role in promoting the development of new antibacterial products.

Antimicrobial resistance (AMR) is increasingly being recognized as a global threat to public health, with the World Health Organization (WHO) calling AMR "so serious that it threatens the achievements of modern healthcare."

One of the main challenges to combatting AMR has been developing new products to fight bacterial infection. Despite recent efforts such as the Generating Antibiotics Now Act (GAIN Act) in the US and the European Commission's action plan against AMR, no new classes of antibiotic drugs have been approved in recent decades.

In June, FDA's Center for Drug Evaluation and Research (CDER) Director Janet Woodcock went so far as to say the pipeline for new antibiotic drugs is "fragile and weak," and emphasized the difficult nature of testing such drugs.

"How do you find these people who are infected, who are maybe scattered around, and then test a drug in them when they are critically ill and they need to be treated right away? So these clinical trials, even small clinical programs, are extremely challenging," Woodcock said.

What Regulators Can Do

With those challenges in mind, FDA, EMA and PMDA agreed on actions they can take action to facilitate the development of new antibacterial products.

First, the regulators said they recognize that they must be more flexible when it comes to clinical requirements for new antibacterial products.

"It is appropriate to exercise flexibility with regard to the requirements for clinical development programmes for antibacterial agents, especially for new agents that may be used to treat patients with limited treatment options because of antimicrobial resistance," the agencies said.

Another way the regulators say they can help is by allowing drugmakers to use the same data for submissions to all three agencies.

The regulators also agreed that they may have to accept more uncertainty about the benefits and risks for antibacterials used in situations where there are "limited treatment options."

"It may be acceptable to conduct trials in smaller numbers of patients than would usually be required," the agencies said.

However, the regulators cautioned that their actions alone will not be enough to address the issues behind antibacterial product development.

"Regulatory activities are only one element of the comprehensive and multifaceted response needed to encourage and accelerate development of new antibacterial medicines that meet patient needs," EMA said.

NIH AMR Competition

In the US, the National Institutes of Health (NIH) are looking to tackle the issue of AMR from another angle through a new competition offering $20 million in prizes for the development of new diagnostics for detecting drug-resistant bacteria.

"My hope is that this competition will spurt exceptional innovators to rise to the challenge and deliver effective tools to help manage this significant problem," NIH Director Francis Collins said.

The competition is jointly funded by NIH and the Biomedical Advanced Research and Development Authority (BARDA), with technical and regulatory assistance from the US Centers for Disease Control and Prevention (CDC) and FDA.

NIH says it will accept submission to the competition until 9 January 2016, with prizes of up to $50,000 to 20 semifinalists and $100,000 to ten finalists. According to the agency, the prize money can be used to "develop prototypes for evaluation by two [Clinical Laboratory Improvement Amendments] CLIA-certified independent laboratories, which will be considered when final winners are selected."

Afterwards, NIH says it will award up to three winners of the competition a portion of the remaining $18 million in prize money, with winners expected to be announced in 2020.


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