13 May 2018

On January 22, 2002 in Bethesda, MD., the LDA was able to get a private meeting with the FDA on the vaccine issue, despite reluctance by the FDA to grant the meeting. Congressman Chris Smith helped facilitate the setup of this meeting. On February 25, 2002, a month after meeting with FDA, LDA received written answers to its questions from FDA and, also, learned that Glaxo SmithKline had quietly pulled Lymerix from the market, citing "poor sales." CLICK HERE FOR THE RESPONSE

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12 May 2018

This is an FDA powerpoint by Robert Ball, M.D., M.P.H., Sc.M., on the Lymerix Vaccine, LYMErix® Safety Data Reported to the Vaccine Adverse Event Reporting System (VAERS), January 31, 2001. Robert Ball, M.D., M.P.H., Sc.M., Division of Epidemiology, Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration (FDA), Rockville, MD  CLICK HERE FOR THE POWERPOINT

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19 January 2015

Thank you for successfully completing a 73 group signon to FDA. No further action needed.
The Lyme Disease Association, Inc. (LDA) has formulated a response to FDA to be included in its comment period on its testing Guidance which will affect specialty lab Lyme tests.

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13 January 2015

FDA is moving forward in the process of finalizing its new Laboratory Developed Test (LDT) Guidance proposal. The proposal would move LDTs from under the jurisdiction of Clinical Laboratory Improvement Amendment (CLIA) regulated by Medicare & Medicaid Services to under the jurisdiction of the Food & Drug Administration (FDA). The FDA now regulates non-LDT lab tests under "medical devices," and "approves" or "clears" tests. Non LDTs are tests which are sold to other laboratories while LDTs are generally tests which are developed and used in one lab, commonly called specialty labs.

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10 December 2014
Time Sensitive Survey: The Food & Drug Administration (FDA) is poised to develop new regulations which may affect access to existing tests for Lyme and other tick-borne diseases. Please click on the link to complete a survey being done by LymeDisease.org, an affiliate of LDA.
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01 March 2010

REMARKS OF PAT SMITH, PRESIDENT, LYME DISEASE ASSOCIATION, INC. BEFORE THE VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE, MAY 21, 2002.  Why more adverse events were seen after the vaccine reached the market: 
    People receiving Lymerix after product launch lived in Lyme-endemic areas.

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Lyme Disease Association, Inc.
PO Box 1438, Jackson, NJ 08527 

888-366-6611 | information line
732-938-7215 | fax
LDA@LymeDiseaseAssociation.org | email

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