Thursday, October 20, 2011

A Virtual Meeting with FDA Commissioner Hamburg

“A lot of regulatory uncertainty is grounded in scientific uncertainty,” said FDA Commissioner Margaret Hamburg at a FasterCures web meeting held earlier this week that brought together hundreds of leaders from all sectors in medical research.

Hamburg underscored the essential role of the agency in advancing biomedical innovation and assuring our nation remains at the forefront. She noted that the FDA needs to be at the cutting-edge of science across all areas and disciplines and to do so would require having both the in-house expertise and strong collaborations with external partners. Additionally, she said FDA needs new tools to increase understanding of disease and more importantly identify opportunities that could make a difference in effectively diagnosing, treating or preventing disease. These knowledge, tools, standards, and approaches are at the center of the FDA’s regulatory science agenda. 

“The FDA has approved more medical products this year than it has approved in decades, and that it has done so with considerable flexibility and timeliness,” Hamburg said. These include groundbreaking therapies that treat lupus, hepatitis, and metastatic melanoma.

She said that though this trend is encouraging, it is important to recognize that the number of new drugs in the pipeline is not as robust. She noted the need to work collaboratively across sectors and bring stakeholders together to create a regulatory pathway that’s transparent, consistent, and predicable and one that builds on the best available science.

Reflecting on more than two years as head of an agency that regulates products that account for 25% of consumer spending, Hamburg said the FDA is evolving and doing more to communicate with external stakeholders in a transparent and efficient manner, having earlier conversations with sponsor companies to determine how products benefit patients, and developing new ways to ensure patient voices are brought into the decision-making process.

When asked about how the agency reconciles the need for science and balancing risk and knowing people's lives are at stake, Hamburg responded by saying that FDA is trying to achieve an integrated approach that emphasizes the safety of the public and health of patients. The agency carefully weighs all decisions based on the known risks and benefits in a systematic and dynamic process. She noted that FDA approves “a lot of drugs that have a lot of risk” when the benefit to the patient is great.

In a recent survey released by the National Venture Capital Association, the FDA and regulatory barriers were pointed to as reasons for capital to be invested outside the U.S. Asked to comment on this data, Hamburg acknowledged that regulatory barriers are a considerable concern to people investing in medical product development but noted that a big percentage of products fail before it even gets to the FDA. She said that venture capital investors will have to be willing to take a considerable amount of risk.

Noting that regulatory reform is necessary to increase investment, she underscored the agency’s efforts to make the regulatory pathway clearer, more consistent, and more predictable. She emphasized the need to apply business approaches to streamline and improve the regulatory process. For example, one of the things FDA is now doing is adopting totally quality management or lean techniques from other industries and applying them to targeted areas to improve process.

A number of webinar participants posed questions about synergy between the FDA and the National Institutes of Health. Hamburg said that it is important to think more creatively about how clinical research resources are used.

“We have to make sure that we have the kind of clinical trial networks and investment in training next generation of researchers that will support a robust research agenda,” she said. “We need to rethink how we structure clinical trials institutionally and organizationally and also how to innovate and develop new clinical trial designs to enable us to get scientific answers in a more timely, less costly way.”

Hamburg said this is the time to develop a national strategy to look at the continuum of factors to advance medical product innovations and development. “We have an obligation to work across sectors to ensure science and technology are leveraged in ways that matter to patients,” she added.

Related Event:
Hear more from FDA leaders at Partnering for Cures, November 6-8, 2011, NYC. FDA officials Margaret Hamburg, Jeffrey Shuren and Stephen P. Spielberg are among the confirmed speakers to address mission-critical challenges in medical research. View the Partnering for Cures Program.

No comments: