US industry leaders have welcomed a first-of-its-kind partnership between the Food and Drug Administration (FDA) and the National Institutes of Health (NIH) aimed at speeding public access to innovative new medicines.

The agencies will work together to develop and implement new tools for regulatory science which, they acknowledge, has fallen far behind developments in translational science.

“We have allowed the arm of regulatory science to become weak and underdeveloped,” FDA Commissioner Margaret Hamburg told a briefing to launch the partnership – and, if this is not corrected, “instead of pulling us into an exalted future. we will row in circle,” she warned.

The initiative, the brainchild of Dr Hamburg and NIH director Francis Collins, will set up a new Joint NIH-FDA Leadership Council which they will co-chair. 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.

In addition, grants totaling $6.75 million will be made available over three years for projects aimed at improving regulatory science, and the two agencies will hold a public meeting in the spring to solicit ideas on how they can work better together.

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.”

The FDS is “the bridge between biomedical research discoveries and new medical products,” and it now has “a special opportunity - and responsibility - to harness advances in science and technology to support our efforts,” added Dr Hamburg. “We are working in collaboration with the best minds and research institutions available, so that we can better develop and utilize new tools, standards and approaches needed to properly assess the safety, effectiveness and quality of products currently in development or already on the market,” she said.

The Pharmaceutical Research and Manufacturers of America (PhRMA) said it was “heartened” by the new partnership and applauded its goal of “bringing needed medicines to market more quickly, while ensuring that sound science remains at the forefront of innovative drug development and regulation,” while Health and Human Services (HHS) Secretary Kathleen Sebelius added: “we know we can deliver new treatments faster and safer if these agencies strengthen their partnership.”

“Communicating throughout the process will help researchers navigate the regulatory process and give regulators the scientific tools they need to quickly assess a treatment’s risks and benefits. For Americans, this is going to mean that new treatments are available safer and sooner,” the HHS Secretary said.

US, EU plan to speed orphan drugs

Meantime, the FDA and the European Medicines Agency (EMA) say they have agreed to accept the submission of a single annual report from sponsors of drugs and biologics which have been designated as orphan products by both the US and the European Union (EU).

Streamlining the process in this way will help regulators better identify and share information through the development of such products, and for sponsors it will reduce the duplication involved in reporting to two separate regulatory agencies, they say. However, the regulators emphasise that use of the new single annual report submission will be voluntary.