FDA, NIH partnership promises better science, faster reviews
February 25, 2010 — 9:39am ET | By John Carroll
The FDA and the NIH say they'll collaborate on a new program aimed at improving the regulatory science used to review the safety and efficacy of new drugs, promising that better science will lead to swifter decision-making.
"We have allowed the arm of regulatory science to become weak and underdeveloped," FDA Commissioner Margaret Hamburg told reporters. If not fixed, "instead of pulling us into an exalted future, we will row in circles."
To get the partnership up and running, the agencies agreed to form a committee of six top scientists drawn from both organizations. They will provide $6.75 million over three years to fund regulatory science research. President Obama's proposed budget also includes $25 million to improve the science in use at government agencies. The regulators even announced a few priorities, like shortening the time it takes to test the potency of flu vaccines. Instead of three or four months, the agencies believe that wait can be halved.
HHS Secretary Kathleen Sebelius promised that "this is going to mean that new treatments are safer and available sooner."
Anyone outside the vaccine field, though, isn't likely to shorten their timelines on regulatory reviews anytime soon. If scientific committees and small budgets were all it took to transform the FDA's review record, the average cost of development would be much smaller than it is today.
Read more: http://www.fiercebiotech.com/story/fda-nih-partnership-promises-better-science-faster-reviews/2010-02-25#ixzz0gcVPmcLP