FDA seeks ways to boost antibacterial drug pipeline

While it is not mentioned in the announcement, the drug-resistant superbug that has now killed 7 people infected at the National Institutes of Health Clinical Center had to be on the mind of FDA officials when they decided to form a task force to help push antibacterial drug development.

In a release Tuesday, the agency said it has formed a 19-member internal task force of scientists and clinicians who, among other things, will try to determine why there isn't a robust pipeline of antibacterial drugs in development and what regulations it might alter to change that.

The FDA says it will "explore novel scientific approaches to facilitate antibacterial drug development, like the broader use of clinical pharmacology data, statistical methods. It will work with "think tanks" and use existing partnerships to push the effort.

The agency notes antibacterial drug development has been in decline since the 1980s while "the persistent and sometimes indiscriminate use of existing antibacterial drugs worldwide" has led to the ascendency of so-called superbugs, like the one that has been killing patients at the NIH Clinical Center. It says more than 70% of the bacteria that cause hospital-associated infections (HAIs) are resistant to at least one type of commonly used antibacterial drug. Citing decade-old data, the FDA says HAIs killed 99,000 of 2 million who contracted them in 2002.

"The creation of this new task force comes at a critical time," said Dr. Edward Cox, task-force co-chair and director of the Office of Antimicrobial Products in FDA's Center for Drug Evaluation and Research (CDER).

There are, of course companies working in this area. Pfizer ($PFE), GlaxoSmithKline ($GSK) and NovaDigm Therapeutics are each in search of a vaccine to stop methicillin-resistant Staphylococcus aureus (MRSA), a staph infection that kills more people in the U.S. than skin cancer. And Cubist Pharmaceuticals ($CBST) expects $1 billion in sales by 2017 from its antibiotic, targeted at difficult-to-treat skin and bloodstream infections. Enanta Pharmaceuticals, a 2012 Fierce 15 company, is developing drugs in this field. Still, with the problem growing, the industry understands there is a need for more.

While hospital-acquired infections are a problem throughout the world, the most public display of the dangers of drug-resistant bacteria has been playing out at the NIH Clinical Center, where a young boy died last week from the same bacteria that had killed 6 other patients at the center after a woman was admitted a year ago with a serious infection that resisted treatment. The drug-resistant form of pneumonia bacteria infected 17 people.

The Washington Post reports that last fall, as the infection was spreading, NIH staff went to extreme measures to try to stop it. It tore out plumbing that was harboring it and hired monitors to watch nurses and doctors to ensure they were were disinfecting their hands. Until the boy came down with the bug in July, 6 months after the last case, the center believed it had eradicated the bug. 

- here's the press release 
- read the Washington Post story

Special Report: FierceBiotech's 2012 Fierce 15

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