D.Bruce Burlington, MD
Center for Devices & Radiological Health
Food and Drug Administration
9200 Corporate Blvd., Room 100E
Rockville. Maryland 20850

Dear Dr. Burlington:

The American Association for Clinical Chemistry (AACC), representing nearly 11,000 professional clinical laboratory scientists, offers the following comments on the Food and Drug Administration’s (FDA’s) proposed Essential Prescribing Information (EPI) initiative. This policy, set forth in a July 1, 1996 letter to device manufacturers, would require manufacturers to provide a summary of the "essential prescribing information found in the complete product labeling" to health care practitioners. Although AACC agrees with the premise of the initiative, to improve the quality of health care information available to health care practitioners, we do not believe this policy is needed for in vitro diagnostic devices.

One of the primary reasons for EPI, as defined in the letter, is to help the practitioner choose the "particular medical device" (or test) that is most appropriate for the patient. The existence of the

CLIA ’88 requirements, however, makes EPI unnecessary for IVDs. The CLIA regulation makes the laboratory director responsible for determining the appropriateness and understanding the limitations of a device, as well as helping primary care providers with the interpretation of the results (section 493.1445). We believe that this direct assistance is more valuable to physicians than summary pages of all the various tests and test methods performed by the laboratory.

In addition, the FDA already requires IVD manufacturers to meet specific labeling requirements that address users’ needs (21 CFR 809.10). This information is routinely used by clinical laboratorians (typically pathologists and doctoral scientists) in hospitals, where many of our members work, to assist physicians in choosing the appropriate tests and interpreting test results—thus meeting EPI’s objective to appropriately inform the end user. The laboratory director, who usually interacts with physicians on a daily basis, is in a better position to identify the needs and wants of the physicians with whom they have relationships and regularly work than a manufacturer who does not have such a relationship.

In addition, we believe that manufacturers have done a good job of providing accurate, useful and understandable information to practitioners working in the point-of-care testing (POCT) environment, where the education, training and skills of personnel vary greatly. Additional labeling requirements seem unnecessary for the POCT setting. Again, in this setting, the information already required by FDA’s labeling regulation seems adequate for providers seeking to make an informed decision on which device to purchase or use.

AACC also has a number of concerns regarding how FDA would implement the EPI policy. If adopted, the policy would require the laboratory to serve as the intermediary between the manufacturer and the practitioner—disseminating the information to the practitioner. Does this also mean that laboratories would be obligated to send any updates from manufacturers to all physicians on the hospital staff or, in the case of a commercial laboratory, to all physician clients? In the case of a commercial facility, this could mean contacting thousands of clients. And, would the laboratory be responsible for confirming that all physicians have received the EPI and subsequent updates? If so, EPI could greatly increase the administrative burden on laboratories, as well significantly increase their legal liability.

AACC also recommends that FDA gather more information from physicians regarding what data they need to make more informed decisions. We are not convinced that physicians want a compendium of EPI sheets, which describes the 100 to 200 test methods offered by most clinical laboratories.

Finally, AACC is concerned that some physicians may request that an analyte be tested by a specific method. Such a request would significantly disrupt laboratory operations with little or no benefit to the physician or the patient. We believe that the responsibility for choosing the test method must remain with the laboratory director.

By way of background, AACC is the principal association of clinical chemists--professional laboratory scientists--including MDs, PhDs and medical technologists. Clinical chemists develop and use chemical concepts, procedures, techniques and instrumentation in health-related investigations. The AACC represents clinical chemists working in hospitals, independent laboratories and industries nationwide. The AACC's objectives are to further the public interest and educational activities and help maintain high professional standards.

If we may be of any assistance, or if you have any questions about our comments, please call me at (717) 531-8316 or Vince Stine, Manager, Government Affairs at (202) 835-8721.




Laurence M. Demers, PhD, DABCC


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