Regulatory Focus™ > News Articles > Hamburg: 'I Understand the Frustration' With Inefficient Regulations

Hamburg: 'I Understand the Frustration' With Inefficient Regulations

Posted 17 April 2012 | By Alexander Gaffney, RAC 

US Food and Drug Administration (FDA) Commissioner Margaret Hamburg spoke at the International Conference on Emerging Infectious Diseases, saying the agency is aware of the "dearth of new products" in the development pipeline to fight infectious diseases, and is doing everything it can to open up new and innovative regulatory pathways to speed products to market.

The 11 March keynote speech by Hamburg-herself a former commissioner of health and physician-focused primarily on what steps FDA is taking to combat the rise in drug-resistant bacteria.

"The time and costs of drug development are a significant barrier," noted Hamburg, who added the unique market pressures for antibiotics, which are taken in short-course treatment and are not particularly lucrative to manufacturers, represents a real challenge.

The "regulatory and scientific uncertainties and challenges" faced by developers when seeking approval for novel antibiotics represent additional barriers, added Hamburg.

"I understand the frustration with regulation that isn't as sound or as streamlined as it should be," remarked Hamburg. The agency is committed to helping to "make the system more transparent, consistent, and predictable."

Hamburg also spent time extolling the virtues of the agency's regulatory science activities, which she said was the keystone in FDA's attempts to build science-based flexibility into the approvals process.

Regulatory science, what Hamburg refers to as "the knowledge and tools necessary for the meaningful and timely development of new products and their review for safety, efficacy, quality and performance," is an essential-an often underappreciated-part of FDA's attempt to modernize the agency.

Calling the development of regulatory science tools "underfunded" and "underdeveloped," Hamburg said leaving these tools to languish would have an adverse effect on the development of new therapies for patients.

"Without advances in regulatory science, promising therapies may be discarded during development because we lack the tools to recognize their potential or because outdated, inefficient review methods unnecessarily delay the approval of critical treatments," explained Hamburg. "On the other hand, both significant dollars and many years maybe wasted assessing a novel therapy that with better tools might be shown to be unsafe or ineffective at an earlier stage."

"We are also focusing on building the partnerships - across government, and with academia, industry, patient groups and others - that will drive the development of innovative medical products and the delivery of better, safer products to the people who need them," added Hamburg.

"We will work interactively with developers and government partners from very early in the development process to define viable regulatory pathways - speeding progress toward product approval by helping to anticipate and resolve bottlenecks, and to identify and address scientific problems that may emerge," concluded Hamburg.


Read more:

FDA - Hamburg: Keynote Address, International Conference on Emerging Infectious Diseases

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