In our prior post, “Biotechnology Industry Pushing for Progressive Changes within FDA,” we discussed one industry group’s proposals for changes within FDA aimed at improving and expediting the drug and biologics approval process. This month, FDA Commissioner Margaret Hamburg outlined FDA’s blueprints for changes within FDA to encourage biomedical innovation as set forth in the document titled “Driving Biomedical Innovation: Initiatives to Improve Products for Patients."  This announcement follows an increase in criticism from lobbyists and political opposition regarding FDA’s approval process and burdensome regulatory process. According to FDA’s press release, Commissioner Hamburg stated, “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. 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.” Following public hearings and external meetings with stakeholders, FDA’s blueprint identifies the following seven areas for major action within FDA:

  1. Rebuilding FDA’s small business outreach services;
  2. Building the infrastructure to drive and support personalized medicine;
  3. Creating a rapid drug development pathway for targeted therapies;
  4. Harnessing the potential of data mining and information sharing, while maintaining strong privacy protections;
  5. Increasing consistency and transparency in the medical device review process;
  6. Training the next generation of innovators; and
  7. Streamlining and reforming FDA regulations.

A number of FDA’s proposed major actions set forth mechanisms of change within FDA intended to lead to an improved and expedited approval process, specifically for personalized medicine, targeted therapies, and devices. To achieve this end, such proposed changes include clarification of agency policies, streamlining the necessary coordination between Centers, and improving transparency and predictability within FDA. To create a rapid drug development pathway for targeted therapies, FDA proposes to host a series of scientific meetings with stakeholders and develop draft guidance on an expedited development pathway. From the outside looking in, FDA’s blueprint is a great starting point, but does not include many, if any, ground shifting methodologies that will initiate significant change within FDA on an expedited basis. However, maybe the changes that need to be made within FDA are fundamental regulatory shifts rather than reinventing the process.

While FDA’s announcement is timely and likely well received amidst industry concerns of regulatory burdens to obtaining approvals of new drugs and the growing chorus of Americans disgruntled about the loss of jobs to outsourcing and the stalled economy, the success of FDA’s blueprint will be determined by whether FDA effectively implements these initiatives and industry and the public sees tangible results. In a post on the White House Blog, Vicki Seyfert-Margolis, Senior Advisor for Science Innovation and Policy for the FDA’s Commissioner’s Office, referred to FDA’s blueprint as “a productive and important first step toward smart innovation-focused reform at FDA.” If this innovative-driven reform is successful as a first-step in putting true change into motion, industry can hope to see a less burdensome approval process resulting in an increase in America’s life science development pipeline and innovative advances from start-up life science companies.