FDA’s Attempts to Implement Continual Improvement Efforts; The 2011 Budget

The Food and Drug Administration, an administration within the Health and Human Services division of the executive branch of the United States federal government, is responsible for protecting public health by “assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products, medical devices, our nation’s food supply, cosmetics, dietary supplements, and products that give off radiation.”
The FDA also regulates the tobacco industry, inspects dairy farms and food processing plants, and is responsible for monitoring product recalls.  The FDA is tasked with reviewing clinical data prior to licensing, granting market approval, and conducting post market surveillance of the effectiveness and safety of licensed products.  This mandate represents an enormous work load and a serious responsibility.
As noted by FDA Commissioner Margaret Hamburg, “…the FDA regulates more than 1 in every 5 dollars of consumer spending in this country…We are responsible for things people really care about and that matter for their health, safety and well-being. And even for things as mundane as the toothpaste we use in the morning, to that midnight snack we may sneak before bed – each of us is relying on the FDA, every day in so many ways. There’s no escaping that.”
There is no doubt that the level of quality achieved while executing these tasks has the potential of affecting the life of every American.
And the burden is increasing.
The problem
The volume of the food and drug market is growing rapidly.
The complexity of the products involved is increasing regularly.
The location of the manufacturers involved continues to expand globally.
The size and scope of the FDA does not change quickly.
For example, despite the 21st Century Initiative Program that sought to create a faster track to market, obtaining approval from the FDA to manufacture a generic version of an innovator drug has slowed considerably.  The approval process used to take 6 months, now; it can take up to 27 months.  The number of applications has more than doubled over the past six years, and the FDA has not been able to keep up with this increase in activity.
Margaret Hamburg acknowledges that this delay is unacceptable but notes frankly that “the unprecedented spike in generics applications has simply outstripped our capacity to properly review, which must remain our foremost focus.  The solution lies in resources,” available to the FDA.
Pending Solutions
The means to supply these resources can only be provided by increased funding, which can only come from Congress or the private sector industries that consume these resources.
The good news – funding to execute functional solutions to backlog reduction, (e.g., hiring more workers), has been addressed within the federal government’s 2011 budget.
The bad news – the 2011 budget for the FDA was proposed in February 2010 and has not yet been approved by Congress.
The federal government’s fiscal year began October 1, 2010.  However, with an unapproved federal budget resource increases in federal funding are not yet available to the FDA.
In addition to the proposed 2011 budget, The Food Safety Modernization Act includes program components that would increase funding available to FDA from within the private sector.
The good news – the Act would allow the FDA to accept substantial user fees, which could fund increases in head count and improvements in the processes that register and inspect food and feed manufacturing and processing facilities, and conduct routine and for-cause inspections.
The bad news – the Act, presented August 12, 2010, continues to await Congressional approval.
Trend Analysis – Promising
The federal government’s 2011 budget for the FDA is $4.03 billion; a 23% increase from 2010
The 2010 budget represented a 19% increase from 2009
These are the largest annual increases in FDA history
FDA Budget 2008, 2009, 2010, 2011

FDA Continual Improvement Goals

2011 Highlights: Food Safety Program Improvements:

The current limited resources available to CFSAN (Center for Food Safety and Nutrition) fall far short of the resourcing levels that would be required to provide an effective layer of preventative governmental oversight.  This initiative includes components that will dramatically increase the agency’s ability to redesign prevention-based processes in order to promote safety and increase the agency’s capacity to keep pace with the market volume and promote productivity:

•      In order to prioritize issue prevention, FDA will:

o    Set standards for safety (for handling produce and samples, etc.), conduct audits of its regulatory and public health partners, and create standards for evaluating food safety systems in foreign countries
o    Expand laboratory capacity
o    Pilot track and trace technology
  •     In order to strengthen surveillance and enforcement, FDA will:
o    Strengthen import safety
o    Improve data collection and food risk analysis by:
•     Collaborating with states to aid with communication of standards, sampling, and compliance
•     Improving risk analysis by targeting certain food for sampling and inspections
•     Expanding NARMS (National Antimicrobial Resistance Monitoring System) focusing on seafood and animal feed
  •     In order to improve CFSAN infrastructure and response time, FDA will:
o    Conduct pilot studies with track and trace technology
o    Improve laboratory capacity by developing technology which will shorten the time needed to test a pathogen
o    Implement enterprising information technology systems that will establish, collect, and support the proposed new Food Registration and Inspection User Fees Program
o    Increase resourcing levels with 718 additional field operatives and food inspectors
o    Increase inspection program effectiveness by adding 4,000 inspections (including 1,900 domestic food safety inspections, 150 foreign food inspections, and 1,000 domestic food and animal feed program re-inspections) to the current schedule
2011 Highlights: Patient Protection Program Improvements:
•      In order to improve safety of imported product, FDA will:
o    Implement an electronic drug registration and listing system blocking importation of unapproved product
o    Increase foreign inspections
o    Review and use third party International Organization for Standardization (ISO) audits of foreign device manufacturers
•      In order to improve the infrastructure with regard to patient safety, FDA will:
o    Increase resourcing levels with 215 additional resources dedicated to patient protection programs
o    Increase and modernize the identification and tracking of high-risk products, including pediatric products, blood products, and medical devices
o    Increasing the post market surveillance mechanism used for medical devices and products
o    Develop public and private sector partnerships to reduce adverse events and work with the private sector to reduce unnecessary exposure to medical radiation
o    Develop an adverse event tracking system for animal use products
o    Increase resourcing levels dedicated to reviewing and approving market authorization applications for new generic drugs
•      In order to promote public health by supporting advances in medicinal sciences FDA will:
o    Support nanotechnology and stem cell research
o    Update standards and establish guidance documents for biosimilars
o    Increase agency ability to regulate animal biotechnology products
The Take-Away?
It is clear that FDA operates internally as they expect the private sector to operate.  Clearly, the agency self-evaluates and uses that data to identify opportunities for improvement, and develops detailed plans to implement identified improvements.
The FDA also shares another characteristic with the private sector; they need to request, justify and wait for funding of quality based program improvements.
As a group of quality engineers, we can see that the effort invested in self-evaluation, problem identification, and solution development has been effective and value added.
We eagerly await the passage of the 2011 budget that will enable FDA to implement these program expansions and improvements.  We feel strongly that they will enable FDA to advance efficiency and productivity.
We also encourage our private sector partners and colleagues to follow this lead.  It may not always be easy to find funding for programs that advance quality and modernize infrastructure, especially in these difficult financial times.  However, the act of self-evaluating alone can lead to valuable growth for any organization.
Even if ideal program funding is never granted, determining which areas require improvement is half the battle.  Even if the flag ship solutions are beyond reach, real improvements in quality can be effected by the implementation of even modest change.
If there isn’t funding available to implement global control technology, consider developing more stringent control system components that can be procedurally driven.  Enhance employee training, develop more precision in communication, and improve risk mitigation plans.
And the Most Critical Take-Aways? 
Never stop critically assessing.
Never stop innovating.
Never stop seeking improvements.
Never allow the size of proposed solutions to stop you from acknowledging the need for improvement.
© Coda Corp USA 2010.  All rights reserved.
Gina Guido-Redden and Corrine R. Knight
1.          http://www.fda.gov/NewsEvents/Testimony/ucm204379.htm
2.         http://www.cbo.gov/ftpdocs/117xx/doc11794/s510.pdf
3.          http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm199516.htm
4.          http://www.aacr.org/home/public–media/science-policy–government-affairs/aacr-cancer-policy-monitor/aacr-cancer-policy-monitor—june-2010/fda,-key-stakeholders-prepare-for-2012-reauthorization-of-pdufa.aspx
5.          http://www.fda.gov/aboutfda/reportsmanualsforms/reports/budgetreports/ucm153154.htm
6.          http://www.ehow.com/facts_6188276_role-fda_.html
7.           http://www.fda.gov/NewsEvents/Testimony/ucm115219.htm
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