Reviving the Antibiotic Pipeline

Reviving the Antibiotic Pipeline

04.22.13 | By Sascha Haverfield, Ph.D.

A new report on the antibiotic pipeline is causing renewed concern given the emergence of antibiotic-resistant “superbugs” with high mortality rates. 

Antibiotic-Resistance Poses Grave Danger

Last month, the Centers for Disease Control and Prevention (CDC) called for action to stop the spread of Carbapenem-Resistant Enterobacteriaceae (CRE), a family of bacteria that kills up to half of patients who develop CRE bloodstream infections.  “CRE are nightmare bacteria. Our strongest antibiotics don’t work and patients are left with potentially untreatable infections,” said CDC Director Tom Frieden, M.D., M.P.H.

There is universal agreement on the severity of the problem and the need to stimulate the development of innovative antibiotics to treat resistant infections. Earlier this year, the Chief Medical Officer for England compared the threat posed by antibiotic-resistant bacteria to terrorism. The World Health Organization highlighted the danger of drug-resistant pathogens for World Health Day in 2011: “In the absence of urgent corrective and protective actions, the world is heading towards a post-antibiotic era, in which many common infections will no longer have a cure and, once again, kill unabated.”

Antibiotics Pipeline on Life Support? 

As recent news stories have reported, the number of antibiotics approved in the U.S. has been steadily decreasing and there are few new antibiotics in the drug development pipeline. In 2009, there were 16 antibiotics in development, none of which had activity against bacteria known to be resistant to all available antibiotics.  Two years later, only 10 antibiotics were in clinical development. 

"Simply put, the antibiotic pipeline is on life support and novel solutions are required to resuscitate it - now," Dr. David Relman, President of the Infectious Diseases Society of America, said in a statement (as quoted in Reuters).

What can be done?

The biopharmaceutical industry stands ready to face the scientific and medical challenges presented by the development of much-needed new and innovative antibiotics – but we can’t do it alone. In order to make the large investment necessary to make a new therapy available to physicians and patients, drugmakers need a clear and predictable regulatory environment.

As we highlighted in a previous Catalyst post, existing regulatory frameworks established by Congress for the Food and Drug Administration (FDA) are sufficiently flexible to permit streamlined development of antibiotics for serious and life-threatening infections.  

Congress highlighted the need for use of broad regulatory flexibility conducive to promoting and incentivizing the development of new medicines for unmet medical needs when it enacted the Food and Drug Administration Safety and Innovation Act (FDASIA) last year.  Congress included enhancements of FDA’s existing accelerated approval pathway and fast track designation procedures, and it created a new “breakthrough therapy” designation. As noted in comments recently submitted to the FDA, PhRMA supports the Agency’s use of these and other tools, such as priority review, to facilitate the development of new antibiotics.

PhRMA is eager to work with FDA and other stakeholders toward the establishment of an appropriate and targeted regulatory approach that will accelerate the development and availability of novel antibiotic and anti-infective medicines.  This goal could be accomplished through a combination of existing regulatory flexibility and voluntary stewardship programs managed by healthcare professionals to address possible antibiotic-resistance issues.

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