Deal agreed to fast-track new drugs

A new partnership between the FDA and the NIH aimed at speeding up public access to innovative medicines have been welcomed by US industry leaders.

According to reports, the US Food and Drug Administration (FDA) and the National Institutes of Health (NIH) will work together to develop and implement new tools for regulatory science, which they believe has fallen behind developments in translational science.

FDA Commissioner Margaret Hamburg briefed the press about the first-of-its kind partnership this morning, saying that "[the industry] has allowed the arm of regulatory science to become weak and underdeveloped". She warned that, "unless this is corrected, we will row in circles."

Collaboration

The Pharma Times reports that the initiative is the brainchild of both Dr. Hamburg and NIH director Francis Collins, who will set up a new Joint NIH-FDA Leadership Council, which they will co-chair. According to their outlining of the partnership, the Council will spearhead collaborative work on important public health issues and work to help ensure that regulatory considerations form an integral component of biomedical research planning, and that the latest science is integrated into the regulatory review process.

Future-proofing

Grants equaling as much as $6.75 million will be made available over the next 18 months for projects that will be targeted at improving regulatory service. In addition, both the FDA and the NIH will hold a public meeting in the spring in an effort to collaborate on ideas about how the two agencies can work better together in the future.

Dr. Collins told the briefing that while the NIH and the FDA have been partners in many initiatives for more than two decades, this collaboration is the first of its kind and "will use the NIH's breadth of experience as a leader in biomedical sciences to help make the translation of biomedical discoveries into effective treatments as seamless as possible."

Matthew Buttell

Matt Buttell graduated from Bath Spa University in 2006. Since then he has written for several publications, before moving to the web. He now writes solely for the internet, continuing to cover key business issues while managing his own personal blog.

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