Regulatory Focus™ > News Articles > Hamburg: Smart Regulation Supports Public Health and Innovation, FDA Creating Business Liaison

Hamburg: Smart Regulation Supports Public Health and Innovation, FDA Creating Business Liaison

Posted 08 February 2012 | By Alexander Gaffney, RAC 

US Food and Drug Administration (FDA) Commissioner Margaret Hamburg delivered a speech at the Commonwealth Club of San Francisco on 6 February in which she discussed FDA's dual role in protecting health and getting innovative products to market.

"As FDA commissioner, I have been surprised by how many people ask whether I favor safety or innovation," said Hamburg. "I favor both."

"Protecting the public health-while encouraging, not discouraging innovation must be the goal…and it is. But it is also why a robust, well-funded, FDA, with the necessary scientific expertise and capability, is so important," said Hamburg.

Hamburg also took the opportunity to fire back at critics of the agency's regulations-critics, she noted, that had "more than once" called her a "job killing regulator."

"[I]n actuality, regulation-when it's done right-isn't a roadblock-it's the actual pathway to achieve meaningful and lasting innovation," said Hamburg. "Smart, science-based regulation instills consumer confidence in products and treatments. It levels the playing field for businesses. It decreases the threat of litigation. It prevents recalls that threaten industry reputation and consumer trust-not to mention levying huge preventable costs on individual companies and entire industries. And it spurs industry to excellence."

"[I]t takes the right regulation to help support job and economic growth, so I fully understand the private sector's frustration with regulation that isn't as sound or streamlined as it should be," continued Hamburg later in her remarks. "And we must address a set of very real concerns."

Hamburg noted that FDA was establishing a small business liaison to help companies navigate FDA processes, and working to reform their systems to promote "prompt and responsive engagement" with stakeholders.

The speech was also meant to commemorate the 50th anniversary of the Thalidomide tragedy, which was averted in the US thanks to the efforts of then-FDA employee Dr. Frances Kelsey. The drug - marketed  as a sedative for pregnant women - was ultimately associated with horrific birth defects and pulled from the market for its original indication.

"Dr. Kelsey's reaction to Thalidomide best exemplifies FDA's mission: protecting and promoting the health of the American people, using science for regulatory decision-making," said Hamburg.


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