FDA Outlines Innovation Plan

This article published with permission from The Burrill Report.

The U.S. Food and Drug Administration has unveiled a new plan to address the most pressing concerns of industry and patient advocates, highlighting its plans to build a better agency as it makes its case to Congress for a bigger budget.

“America is at an important crossroads, where the science before us presents unprecedented opportunities to create new and better medical products and to promote better health for the public,” says FDA Commissioner Margaret Hamburg. “Our innovation blueprint highlights some of the initiatives FDA will be implementing to ensure that these opportunities are translated into safe and effective treatments that can help keep both American patients and American industry healthy and strong.”

The plan, published as “Driving Biomedical Innovation: Initiatives for Improving Products for Patients” arose from an internal review Hamburg initiated within the agency and draws on conversations the agency has had with industry representatives, health care professionals, academicians and consumer advocates.

Actions outlined in the plan’s “Innovation Initiative” could make the going easier for industry. Some steps are aimed at improving its review process. These include building infrastructure to drive and support personalized medicine, creating a rapid drug development pathway for important targeted therapies, and improving consistency and clarity in the medical device review process.

Other actions include initiatives to better support FDA’s relationship with regulated stakeholders, such as a plan to rebuild FDA’s small business outreach services and another to streamline and reform FDA regulations.

How much the FDA is able to achieve will depend at least in part on whether it can secure funds to support its plans. So far, President Obama’s $2.7 billion request for the agency has met with pushback in both the U.S. House of Representatives, which wants to trim the agency’s budget, and the Senate, which has approved just a small increase from fiscal 2011.

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Patient advocate concerns also got attention, with a promise from the FDA that it would work to harness the potential of data mining and information sharing while protecting patient privacy.