A Journal for Industry Executives

Brought to you by

Last week, FDA Commissioner Dr. Margaret Hamburg formally announced the deployment of PREDICT–the Predictive Risk-Based Evaluation for Dynamic Import Compliance Targeting.

“PREDICT is an exciting innovation that harnesses advances in information science to enable us to do our job better and to improve our service to the nation” said Dr. Hamburg. “But it is just one step. More broadly, we are moving from a system that places most of the regulatory burden on the FDA’s modest inspection force, to one that creates greater oversight at points further back along the production chain” she added.

The system was piloted in Los Angeles and is currently going online in New York. FDA’s targets to have PREDICT up and running around the country by late Spring 2010.

PREDICT is a sophisticated information technology system developed for use by border inspection operations. The system allows FDA inspectors to monitor products at the port of entry more reliably and to target shipments for inspection that pose the greatest risk.  It utilizes Analytics and Business Intelligence tools to rank product shipments according to risk. Based on these assessments, it decides which shipments should be checked upon arrival.
The System enables FDA inspectors to spend more of their time looking at the highest-risk items. PREDICT will by automatically flag potentially risky shipments as well giving lower risk scores to materials that are more innocuous and those products with good FDA compliance histories.

To make these decisions, PREDICT takes into account information on:

• Product manufacturer
• Manufacturing site location
• Inspection site of manufacturing facilities
• Manufacturer’s level of supply chain accountability
• Criticality of final products marketed

This is especially important give that FDA-regulated products marketed in the US are manufactured in more than 300,000 foreign facilities in over 150 countries around the globe.  This year, nearly 20 million shipments of food, devices, drugs, and cosmetics will arrive at U.S. ports of entry.

“I can assure you that addressing the problem of global supply chain safety, and shifting the existing paradigm from reaction to prevention, is one of my highest priorities for FDA”  said Hamburg. “Refining our understanding of the problem and exploring and assessing possible solutions will be a major focus of our work over this next year and well beyond.”

As we identified in our “FDA eTransformation Initiatives” research study, the Agency is making significant investments in Information Technology to support its mission. PREDICT is another leap forward on FDA’s shift from a model that places most of the regulatory burden on its inspection force, to one that creates greater oversight further back along the supply chain.  The use of Analytics, Business Intelligence and Information Technology takes FDA’s “Risk Based Approach” to a higher level.

See a video of PREDICT in action

The FDA is requesting $4.03 billion to promote and protect public health as part of the fiscal year 2011 budget. This represents a 23 percent increase over the agency’s current $3.28 billion budget and includes a $146 million increase in budget authority and $601 million in industry user fees.

According to FDA Commissioner Margaret A. Hamburg, M.D. “The FY 2011 resources will strengthen our ability to act as a strong and smart regulator, protecting Americans through every stage of life, many times each day. This budget supports the ability for patients and families to realize the benefits of science that are yielding revolutionary advances in the life and biomedical sciences.”

The budget request reflects commissioner Hamburg’s resolve to transform food safety practices, improve medical product safety, protect patients and modernize FDA regulatory science to advance public health. This budget also funds FDA’s new regulatory authority over cigarettes and other tobacco products.

According to the agency, four initiatives are the major highlights for the FY2011 budget increases:

Transforming Food Safety (+ $318.3 million)
The Transforming Food Safety Initiative reflects President Obama’s vision of a new food safety system to protect the American public. The FDA will set standards for safety, expand laboratory capacity, pilot track and trace technology, strengthen its import safety program, improve data collection and risk analysis and begin to establish an integrated national food safety system with strengthened inspection and response capacity.

Protecting Patients (+ $100.8 million)
The Protecting Patients Initiative advances the Obama Administration’s priorities for safe, quality health care for all Americans. The resources in this initiative will support the safety of drugs, devices, and vaccines, as well as the Nation’s blood supply. The FY 2011 resources will also strengthen the FDA’s ability to act as a strong and smart regulator to address medical product safety challenges in the years ahead.

Advancing Regulatory Science (+ $25.0 million)
Advancing Regulatory Science builds on President Obama’s commitment to harness the power of science for America’s benefit. During the past two decades, extraordinary investments have led to revolutionary advances in the life and biomedical sciences. Many key discoveries, however, have yet to translate into real therapies for patients. The FY 2011 budget will allow the FDA to begin to strengthen its core scientific capacity. This investment will allow the FDA to identify improved pathways to product development and approval for new technologies that offer promising new opportunities to diagnose, treat, cure and prevent disease.

Tobacco (+ $215.0 million)
An increase in tobacco user fees will allow the FDA to continue to implement the Family Smoking Prevention and Tobacco Control Act. Preventing youth from using tobacco and helping Americans quit, promoting public understanding of the harmful constituents of tobacco products, developing the foundation of science for regulating tobacco, and regulating tobacco to reduce the toll of tobacco-related disease, disability and mortality are tobacco program priorities for FY 2011.

In our December 2009 article “What to Expect from FDA in 2010“ I stated that time would tell how the FDA’s current vision would affect industry and consumers. It is evident that through this budget request, Commissioner Hamburg is seeking the resources needed to achieve her vision for the FDA as a Public Health Agency. As she stated shortly after she took office, FDA’s role is to “Minimize Risks Through Education, Regulation, and Enforcement.”

The complete FDA FY2011 budget is available at: http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/BudgetReports/UCM199447.pdf