FDA outlines regulatory science initiative

The Food and Drug Administration on Wednesday unveiled a White Paper outlining the agency's plans for developing new tools to determine whether the products it regulates are safe and effective.

The agency unveiled its Advancing Regulatory Science Initiative in February. The new White Paper offers a framework for the initiative.

"Regulatory science can deliver us better, more targeted therapies and more swiftly," FDA Commissioner Margaret Hamburg said during a luncheon speech at the National Press Club. "It can impact not only individual health, but improve our healthcare system more broadly. And it can lead to significantly lower costs for the drugs and medical products we need."

Hamburg also said that:

• She expected Congress to have passed food safety legislation by now and her speech was initially supposed to be about that subject "close to my heart." But the bill has been held up by Sen. Tom Coburn (R-Okla.);

• The FDA "will not have a one-size-fits-all approach" for the evaluation of follow-on biologics but "each one or different categories ... will have to be assessed in terms of what is the level of data and evidence that will be needed to show equivalence and substitutability";

• And "there's a growing recognition that the FDA has not been adequately funded for a period of any years" but that has changed over the past couple of years and she's "guardedly optimistic" that the agency will continue to get the support it needs. President Obama had sought a 23 percent increase in funding for the FDA for 2011 - including $25 million for the regulatory science initiative - but Congress failed to pass a budget and funding for most agencies will be flat as a result.