FDA WARNING_LETTER - Lippton, Howard M.D. - February 04, 2010

On February 2-4, 2010, the FDA inspected Dr. Howard L. Lippton's conduct of a clinical investigation for the investigational drug (b)(4), Protocol (b)(4). The inspection, part of FDA's Bioresearch Monitoring Program, revealed non-adherence to statutory requirements and FDA regulations.

The primary violations include: 1. **Failure to assure IRB review (21 CFR 312.66):** Dr. Lippton submitted an inaccurate Research Site Submission Form to the (b)(4) IRB on April 2, 2009. He incorrectly answered "no" to questions regarding prior conviction (health care fraud in 2002) and state medical board disciplinary action (Louisiana license suspension in 2003). This false information prevented the IRB from effectively reviewing and approving Protocol (b)(4), leading to the IRB withdrawing its approval. Dr. Lippton's claim that a study coordinator completed the form was rejected, as he signed and certified its accuracy. 2. **Failure to protect subjects' rights, safety, and welfare (21 CFR 312.60):** By providing false information to the IRB, Dr. Lippton failed to ensure the IRB had accurate data necessary to protect human subjects, thereby violating his responsibility.

The FDA requires Dr. Lippton to address these deficiencies and establish procedures to ensure future compliance.