Before turning to 2012, FDA Matters wanted to take one more look at FDA’s performance in 2011. So much happens at FDA that it’s easy to lose perspective. And no matter what the agency does, somebody will be unhappy. So, should Commissioner Hamburg feel good about the last 12 months?
FDA Matters thinks it comes down to how well FDA handled the three most important challenges it faced:
- improving the medical product review process, including stimulating innovation;
- implementing the Food Safety Modernization Act; and
- advancing the agency’s ability to assure the safety of imports.
Before exploring these particulars, FDA Matters feels FDA staff and Dr. Hamburg should be applauded just for surviving the daily grinding pressure of the agency’s workload. As I have noted previously, FDA’s greatest strength is its people.
Medical Product Review Processes. Was it a good year? The approval process for drugs, biologics and medical devices elicited widespread criticism that FDA was too slow, too risk-averse, underweighted patient benefit, and was demanding certainty where none was possible. The unhappiness was constant and palpable from medical device stakeholders; more muted, but still quite strong among bio-pharmaceutical stakeholders.
As the year went on, this critique of the agency increasingly coalesced under the rubric of innovation. Specifically, FDA was accused of creating processes and making decisions that stifle American innovation and cost American jobs.
FDA formulated its response in several ways:
- Integrated innovation-oriented benchmarks and goals as core components of both prescription drug and medical device user fee negotiations,
- Outlined innovation initiatives in February 2011, CDRH Innovation Initiative, and October 2011, Driving Biomedical Innovation: Initiatives to Improve Products for Patients,
- Appointed Stephen P. Spielberg, MD., PhD, an academician and industry veteran as Deputy Commissioner for Medical Products with the intent that he would focus his efforts on promoting medical product innovation, and
- Focused public attention that 35 new innovative medicines were approved during fiscal year 2011, a notable increase over the prior year.
Optimistically, I believe these actions are the start of a turning point for the agency. The largest barrier is not agency leadership’s willingness to promote innovation…rather it is that combining public health and innovation requires a new identity for the agency, something that can't happen overnight.
Food Safety. Was it a good year? At the very end of 2010, Congress passed the Food Safety Modernization Act (FSMA), which creates a sophisticated risk-based food safety system that stretches from the farm to our tables. The new law created or enhanced FDA authority in the following areas: prevention, inspection and compliance, response to problems, imports, and enhanced partnerships with other food safety agencies.
Implementing the new law is a complex multi-faceted task that has been made even more difficult by inadequate funding. Further, many of the new law’s mandates became effective quickly, leaving little opportunity for manpower and IT resources to be mustered to the tasks.
The agency just released its one-year progress report and there seems to be general consensus that the agency has done a tough job well. Year two (2012) will be at least as challenging, but we are definitely one-year closer to a safer food supply.
Imports. Was it a good year? The third major challenge to FDA in 2011 was continuous rapid globalization of the world markets for food, drugs, and medical devices. Almost every country in the world produces raw materials, ingredients or finished goods that become part of imported products regulated by the FDA.
In July 2011, the FDA issued a special report, Pathway to Global Product Safety and Quality, which describes the enormous impact of globalization on FDA-regulated products. FDA is responding through:
- closer partnerships with its foreign counterparts and public-and private-sector third parties,
- development of global data information systems,
- continued expansion of its capabilities in intelligence gathering, and
- allocation of agency resources based on the risk of a food safety problem.
During 2011, the agency further expanded its network of overseas offices and reorganized its headquarters oversight. The latter was accomplished by appointing Deborah Autor as the new Deputy Commissioner for Global Regulatory Operations and Policy.
Conclusions. In upcoming columns, we will be detailing the challenges facing FDA in 2012. Meantime, we urge Dr. Hamburg and all of FDA to take a moment to think back with pride to 2011. You had a good year.
Steven