Dr. Schultz resigns as head of FDA’s medical device center


The industry newsletter, The Gray Sheet and the Wall Street Journal both reported that Daniel Schultz, MD, Director of the Center for Medical Devices and Radiological Health (CDRH) offered his resignation to Dr. Margaret Hamburg, the new FDA Commissioner. Schultz said that the resignation was an agreement between him and Hamburg stating that Dr. Hamburg agreed his resignation “would be in the best interest of the center and the agency.” That doesn’t look good on your CV.

Dr. Schultz was under many clouds of suspicion. There have been serious charges leveled at the management of CDRH by employees conducting scientific review of new medical devices submitted to FDA. This is actually a very big deal. The Gray Sheet article is attached on the Blogroll as, “2: Schultz resigns.” I am very curious who else will be resigning in the Hamburg Era.

UPDATE: The Wall Street Journal reports on Dr. Janet Woodcock, Dr. Schultz’ counterpart at the Center for Drug Evaluation and Research, having conflict of interest problems. Read their coverage on the Blogroll: “11WSJ: Drug chief accused of conflict.”

4 Responses to Dr. Schultz resigns as head of FDA’s medical device center

  1. average scientist says:

    Carl,

    Do you know if retaliatory actions against FDA employees have been neutralized and reversed and reforms instituted? Mr./Dr. Hopson, the author of the FDA memorandum quoted in your report, and the nine whistleblowers paid a significant price for reform. Are there any efforts to restore their reputation?

  2. Carl's Blog on FDA Stuff says:

    It is a very good question to which I do not have the answer. I only worked at CDRH for two months in 2004 and live on the west coast which keeps me out of the loop on these things. I would suggest asking the question to FDA on their “Transparency Blog” that can be accessed on the FDA homepage. I strongly support “whistleblower” protection for government employees.

  3. An Average Scientist says:

    King Schultz is gone; however, his circle of officers remains. A GAO or OIG is still needed to uncover whether any FDA activity has compromised the health and safety of America consumers.

    I commend the FDA scientists; particularly the whistleblowers and the authors of the August 31, 2006, memorandum identified in your report, for courageously sounding the alarm on what appears to be a very serious problem.

    However, some scientists were driven out of CDRH for investigating criminal activity (fraud, research misconduct, bribery) in applications. Their investigations raised serious questions about the scientific integrity of the FDA medical device approval process. Dr. Marcarelli, Mr. Timothy Ulatowski, and Dr. Donna Bea Tillman know who they are.

    I look forward to return of these dedicated public servants. CDRH needs all of its talented employees to ensure that the medical devices Americans depend on are safe and effective.

    • Carl's Blog on FDA Stuff says:

      I have received several comments from “Average Scientist” about the situation in CDRH. Although I agree with the overall concerns expressed, I do not wish to be a forum for disgruntled former CDRH employees, of which there are many. I also do not agree with calling Dr. Schultz, “King Schultz.” There are better ways to express ourselves. Anyway, this will be the last comment I publish on this topic for “Average Scientist.”

      Please read the GLP Memo at the top of the Blog if you want to know more about this issue.

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