FDA Interactions

A routine inspection of test site (Advanced Interventional Pain Center, Indiana) was conducted in September of 2013, where the LILA medical device was used for a clinical trial. The inspection identified 9 patients who were not part of the trial, but were misconstrued as being part of the trial. The inspectors requested the required additional documentation to be sent to FDA’s Detroit Office. In response, the IRB was disbanded, since the clinical trial was already completed and new patients were not being enrolled while the additional documents were sent to FDA’s Detroit office. The additional documentation when sent to FDA’s Detroit office were returned as undeliverable several times. See pictures below. The non receipt of the additional documentation triggered the FDA warning letter from its DC office. These warning letters contain 100% misinformation that is not substantiated by any facts and on the pretext that the requested information was not received by the FDA. On clarification that FDA’s warning letter was unsubstantiated, FDA issued a final letter in May of 2014 indicating that the actions taken were satisfactory and eventually resolving the matter (See attached). This final letter is not available on FDA’s website for public view resulting in incomplete and incorrect information regarding these warnings by the public who happen to see only the warnings but not test site’s response or the resolutions. FDA purposefully avoids publication of letters of resolution creating a public impression that its actions are justified. In this instance it wasn’t. As a result, Dr. Srinivasan, who has been a pioneer in bringing new and safe pain treatments to his patients has often been  misconstrued as someone who has been sanctioned by the FDA and or as someone who disregarded patient safety and treatment standards by those who happen to view only the FDA’s warning letters but not the company’s response or FDA’s final resolution letter. Furthermore, it should be emphasized that “FDA is NOT a physician.” FDA does not direct or control clinical care of patients by their physicians.

For these reasons, Advanced Interventional Pain Center is posting this information for public view and clarification. Despite requests to the FDA to retract its unnecessary, not at fault warning letters, FDA has not done so. From the evidence presented below, it is clear that the FDA warning letters were the result of FDA’s own non compliance in having FDA offices with undeliverable addresses and not the test site or the investigator’s fault.

In 2020, FDA further clarified that “FDA does not intend to interfere with the physician-patient relationship and the associated treatment decisions that you (Dr. Srinivasan) have determined are in the best interest of your patients” Physician treatments with a device cannot be used for collecting prospective data for FDA submissions i.e. investigative determinations on safety and effectiveness (this activity was already concluded in 2013 and all data already submitted to the FDA). FDA will NOT interfere with any treatments performed by a physician in the best interest of the patient. See below: