Archive for the 'Notes From the President' category

Notes from the President: APHL Meets with FDA on Food Laboratory Concerns

Mar 01 2011 :: Published in Food Safety, Notes From the President, Partners

By Dr. Patrick Luedtke, M.D., President, APHL, Director, Unified State Laboratories, Utah Department of Health

As a member of FDA’s Council of Association Presidents, APHL recently participated in a meeting which provided the opportunity to discuss the concerns of the food laboratory community with senior FDA leadership.  Mike Taylor, Dara Corrigan, Joe Reardon, Steve Solomon, Jeff Farrar, and David Elder represented the Office of Foods and the Office of Regulatory Affairs. APHL, as well as many of the other associations present, used this opportunity to convey the crisis status of most state budgets.

A recent Institute of Medicine Report entitled Enhancing Food Safety: The Role of the Food and Drug Administration suggests that the FDA leverage state and local resources in meeting their statutory requirements while conserving dwindling federal resources. Owing to each association’s presentation, it is clear FDA officials present at the meeting now have a better appreciation of what little there is to leverage at any level of government given the current economic environment.  Despite this challenge, all agreed to continue work toward common public health goals and food supply protection.  It is also worth noting that FDA reiterated many times during the meeting their intent to improve communication channels between the Agency and their state and local partners.

Other concerns specific to the food laboratory community were addressed by APHL at this meeting.  Despite the absence of a funded working relationship between APHL and FDA, APHL offered our assistance in support of recent moves toward food laboratory accreditation, and we volunteered to participate in FDA initiatives to implement the directives in the FDA Food Safety Modernization Act.   Further, we offered our training and education expertise to hold food testing courses for FDA’s customers, and we reminded FDA that many APHL member laboratories have the ability to assist with method development and validation activities.  FDA leadership was not optimistic about finding new funding sources for either the Association or state and local agencies, but they were very receptive to hearing our ideas around accreditation and training.

We are extremely grateful to have had this opportunity to meet with senior FDA partners, and we will continue to discuss collaborative opportunities that meet the needs of the FDA, APHL, and our public health and agricultural laboratory members.

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Notes from the President: Strengthening the Relationship Between APHL and EPA

Sep 24 2010 :: Published in Environmental Health, Notes From the President

By Dr. Patrick Luedtke, M.D., President, APHL, Director, Unified State Laboratories, Utah Department of Health

I just returned from a wonderful meeting at the Environmental Protection Agency (EPA) national office in Washington DC with the EPA Deputy Administrator Bob Perciasepe and Phil Metzger (Advisor to the Deputy Administrator). In attendance from APHL were Scott Becker (Executive Director), Peter Kyriacopoulos (Senior Director Public Policy), and Megan Latshaw (Environmental Health Program Director).

The core discussion revolved around the potential benefits of an EPA Laboratory Office that would serve to coordinate all environmental laboratory-based policy, practice, and program efforts in a cross cutting fashion. Additionally, this office would serve as a single point of contact for laboratory-based communication efforts to external partners.

A secondary discussion involved the need for a single data standard across EPA. This discussion included sharing knowledge of the challenges governmental environmental laboratories face concerning multiple data systems, as well as the major benefits that would accrue to our national environmental laboratory system should such a single data standard be adopted.

Most importantly, our conversation enabled us to describe the interaction between State and local governmental environmental laboratories and EPA, and share a vision on how that interaction can evolve and lead to even better health outcomes. All in all, it was deeply gratifying at a professional and personal level to engage in such a collegial and congenial dialogue – a dialogue that I am excited about continuing as the relationship between APHL and EPA matures and strengthens.

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Notes from the President: Preventive Laboratory Services

By Dr. Patrick Luedtke, M.D., President, APHL, Director, Unified State Laboratories, Utah Department of Health

Notes from the President will be a regular series.

Currently public health laboratories focus on infectious disease. Recently an APHL member and fellow lab director asked me for my thoughts on branching out to testing related to chronic disease prevention. I have given a good deal of thought to how public health labs will or could fit into a new prevention-based health system, which seems to be bounding down the healthcare highway toward us at a high rate of speed. While I certainly have no solutions, I have no shortage of ideas and concerns.

It seems to me the roles of public health laboratories in a prevention-based health system could be made to fit into four broad categories:

1. Provision of test results

Public health laboratories could begin or continue providing a panel of prevention-based testing that perhaps focuses on CDC director Dr. Thomas Frieden’s “winnable battles.” Testing could include fasting blood sugars, lipid panels, and others. Some of APHL’s local laboratory members already perform this testing on a regular basis. For others, it seems to me adoption of this type of testing would be quite dependent on local/state politics.

2. Prevention-focused research

I envision public health laboratories could play a meaningful role in prevention-focused research.  For example, we are approaching 80 million American adults with hypertension, 95% of whom have no known cause for their high blood pressure.  Additionally, it is well known that high blood levels of calcium and potassium as well as low levels of sodium produce significant decreases in many with high blood pressure. That being said, very little is known about body-burden of select metals/chemicals at birth and the resulting development of hypertension.  The same could be said of other common diseases of public health import.  Therefore, given the public health laboratory’s role in newborn screening (NBS), it is not a stretch to imagine an expansion of the NBS panel to include heavy metals, other select chemicals, etc. with the aim of identifying “at-birth risks” for chronic disease development.

3. Regulatory systems

It seems to me that traditional public health laboratory roles of oversight in the clinical lab arena will likely not change substantially in the future. In fact, they may expand as point-of-care testing increases and direct access testing labs proliferate.

4. Health outcomes partnering

I believe public health laboratories have an opportunity to move from the old “program evaluation” and internal “quality improvement initiative” paradigms to become active members in systems that focus predominantly on the final impact an intervention has on patient outcome. This is an area that clinical medicine is rapidly moving into, and an area I feel that public health laboratories need to seriously study.

– The opinions expressed here represent those of the author and not APHL.

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