Encouraging FDA to Utilize Existing Regulatory Flexibility to Facilitate the Development and Approval of New Antibacterials

A sustainable pipeline of safe and effective antibacterials is critical to successfully treat serious and life-threatening infections

08.05.13 | By Sascha Haverfield, Ph.D.

As noted in past Catalyst posts, the urgent need for new antibacterials is undisputed.  A recent article in Nature states that, “Health officials are watching in horror as bacteria become resistant to powerful carbapenem antibiotics — one of the last drugs on the shelf.”

Even when antibacterials are used appropriately, antimicrobial resistance is an inevitable evolutionary consequence of antibacterial use and necessitates a constant supply of new antibacterial medicines to augment existing options. Appropriate use of antibacterial agents helps slow the emergence of antibiotic-resistant organisms, but a sustainable pipeline of safe and effective antibacterials is still critical to successfully treat serious and life-threatening infections.

PhRMA and our member companies are committed to innovation and helping ensure that patients have access to safe and effective new medicines in the shortest time possible.  We also recognize the particular importance of developing and securing the approval of new antibacterials that can prevent the mortality and debilitating morbidity associated with emerging or drug-resistant pathogens. For patients affected by such pathogens, timely access to new medicines can be a matter of life or death.

In comments submitted to the Food and Drug Administration (FDA) last week on New Approaches to Antibacterial Drug Development, PhRMA reiterated our support for the Agency’s use of existing regulatory flexibility and the development and revision of guidance to advance novel scientific approaches to facilitate antibacterial drug development. FDA’s existing regulatory options are strong and were further enhanced through new provisions relating to accelerated approval and breakthrough products in the Food and Drug Administration Safety and Innovation Act which was signed into law last July.

PhRMA stands ready to work with the FDA and other stakeholders to address patients’ health needs, our shared priority. Protection of the public health demands that we use the best available science and existing broad regulatory flexibility to restore the antibacterial pipeline and bring new medicines to patients who urgently need them.



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