Hamburg Touts FDA's Promotion of a 'Robust Field of Regulatory Science' in Speech

Posted 30 April 2012 | By Alexander Gaffney, RAC 

US Food and Drug Administration (FDA) Commissioner Margaret Hamburg touted her agency's efforts to advance and promote a 'robust field of regulatory science' in a speech before a NEHI Conference.

Calling regulatory science "important," Hamburg laid out some of what FDA has managed to accomplish in the last few years, including the establishment of three Centers of Excellence in Regulatory Science, working to get the Reagan-Udall Foundation up and running and the formation of a Joint Leadership Council with the National Institutes of Health to promote translational science.

Hamburg said promoting regulatory science-the use of scientific technologies to advance regulatory decision-making-has often fallen on deaf ears.

"Frankly, these days, at least in Washington, you are far more likely to hear the word "regulatory" linked to the phrase "job-killing" than to "science," quipped Hamburg. "But believe me, this is a short-sighted view."

To combat this view, Hamburg said the agency is looking to make numerous investments in regulatory science to help both patients and industry get the therapies they need approved even faster.

"In my view, regulatory science is the critical link-the bridge-between cutting-edge discoveries and real-world diagnostics, treatments, and cures," Hamburg said. "A robust field of regulatory science can enable us to use our knowledge of biological pathways and gene variants to help identify promising new drug candidates and new potential targets for treatment."

Among the many benefits of that "robust field of regulatory science" includes cost savings, faster treatments, new uses for old medicines, broad-based benefits for entire drug classes instead of single drugs, advancements in personalized medicine, improved clinical trial design, the improved use of existing FDA data, safer medicines and a plethora of other benefits, said Hamburg.

Hamburg also addressed economic matters, both from the perspective of the agency and from industry.

"[W]e need a comprehensive, integrated strategy that engages the full "eco-system" to advance biomedical product innovation," Hamburg said. "And-without doubt-that includes promoting innovative products and advancing regulatory science."

Those investments cost money, noted Hamburg.

"Increased funding would certainly help us address the many mandates given to us by Congress-and to fulfill our unique and essential mission to promote and protect the health of the public."

Industry could also stand to benefit from those investments, added Hamburg.

"Importantly-and uniquely-investments in regulatory science can help address growing threats to the economic health of the innovative US pharma and biotech industry and help to grow more broadly our national economy," Hamburg said. "These investments would increase high-value jobs in key sectors, foster innovative products that will drive economic development, and enhance the safety and value of our exports, elevating our global economic competitiveness and overall national prosperity."

This is particularly important because of the "patent cliff" so many companies are now facing. Paired with a weak economy and changing reimbursement models, regulated industry is facing relatively bleak financial prospects.

Hamburg also acknowledged "concerns with the FDA," particularly a "lack of predictability, consistency and transparency in our decision-making processes," but said she is working "hard to address" them.

Ultimately, any solution will have to be collaborative, concluded Hamburg.

"Meaningful and enduring solutions will require true collaboration by stakeholders - and strong leadership from business, academia and government. 


Read more:

Hamburg - "FDA Innovates"

Regulatory Focus newsletters

All the biggest regulatory news and happenings.


Most Viewed Articles