Recent Advocacy Activities
APHL Submits Comments to FDA Regarding the Proposed Framework for Oversight of Laboratory Developed Tests
In October 2014, the Food and Drug Administration released a draft regulatory framework for the oversight of laboratory developed tests (LDTs). The framework outlines a risk-based regulatory scheme that will require notification, premarket review and medical device reporting. As written, the framework has the potential to greatly reduce or eliminate testing that provides important public health benefits. APHL presented at a public meeting held by FDA in January 2015, and submitted a comment to the Federal docket outlining recommendations to FDA that seek greater flexibility for public health laboratories under the oversight.
APHL Submits Comments to DHS on the Guidance Patient Decontamination in a Mass Chemical Exposure Incident
APHL submitted comments to the Department of Homeland Security asserting that public health labs have the capability for immediate detection and identification of a chemical which is critical for assessing need for and evaluating decontamination in response to a chemical incident. Also, internal exposure to a potential chemical threat agent requires follow up testing. Public health laboratories have the capability to perform biomonitoring, a tool used to measure environmental chemicals in people’s blood, urine and other fluids. Biomonitoring also provides critical information for responding to public health problems involving chemicals. From the public health laboratory perspective there is not only the patient diagnostic and decontamination effectiveness aspect but also the assessment of exposure of the first responders and first receivers from patient contact and decontamination and the coordination of these activities in a mass casualty/exposure incident.
APHL Submits Comments to the FDA on the Proposed Rule to Reclassify Nucleic Acid-based in vitro Diagnostic Devices for the Detection of Mycobacterium tuberculosis (MTB)-complex
APHL submitted comments to the Center for Devices and Radiological Health, Office of In Vitro Diagnostic Device Evaluation and Safety, FDA on the proposed rule to reclassify nucleic acid-based in vitro diagnostic devices of the detection of Mycobacterium tuberculosis (MTB)-complex in respiratory specimens from class III (premarket approval) to class II (special controls). APHL supports the reclassification of nucleic acid-based systems for the detection of MTB-complex but is concerned that the proposed rule will have minimal impact of the approval and/or development of current or future products for detection of M. tuberculosis in the United States.
APHL Submits Comments to the FDA Blood Products Advisory Committee Meeting on the OraQuick In-Home HIV Test
APHL provided feedback on the upcoming FDA Blood Products Advisory Committee meeting to discuss the evaluation of the safety and effectiveness of the OraQuick In-Home HIV Test. Although APHL and its members would like to increase access to HIV testing, there are concerns about the performance of the OraQuick In-Home HIV Test in the home setting by untrained users who may not adhere to test instructions, decreased sensitivity and specificity of rapid HIV tests on oral fluid compared to blood specimens, the lack of assurance that users with positive results will seek appropriate confirmatory testing, counseling and linkage to care, and the potential loss of the link to public health systems currently in place to monitor disease and provide partner notifications
APHL Comments on Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators
APHL submitted comments to the Office of the Secretary of the Department of Health and Human Services (DHHS) and the Office of Science and Technology Policy’s (OSTP) Advance Notice of Proposed Rulemaking regarding changes to the Common Rule. APHL argued that requiring written consent for the secondary use of biospecimens previously collected for non-research purposes will be detrimental to public health laboratories and inhibit the ability of public health laboratories to perform diagnostic test development and validation, as required by the Clinical Laboratory Improvement Amendments (CLIA), and to perform vital disease surveillance and prevention activities.
APHL is in favor of the proposed changes to the enforcement actions for proficiency testing referral. Allowing the Secretary discretion in dealing with “unintentional referrals” allows laboratories that have made an honest mistake to continue the important work that they do. APHL believes that clarification, education and examples on what exactly constitutes an intentional and unintentional referral will be necessary.
APHL Comments on the Proposed Rule: CLIA and HIPAA Privacy Rule: Patients’ Access to Reports
APHL is concerned about the tremendous financial burden and additional time it will take for public health laboratories (PHLs) to develop, initiate and implement processes for patient access to testing results. The proposed rule will place additional stress on PHLs, which are already struggling because of workforce reductions and declining budgets.
Public Health Preparedness and Response
APHL Letter to the Select Agent Program
APHL issued an official letter in response to the Federal Register Notice (Volume 76, No. 191, October 3, 2011), providing comments on the proposed changes which would impact the Laboratory Response Network and public health laboratories throughout the country.