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A Resignation and an Allegation at FDA

Several reporters called me last week to ask if I had heard about Dan Schultz’s resignation as head of the Center for Device and Radiological Health (CDRH). Had I also heard about conflict-of-interest (COI) allegations against Janet Woodcock, head of the Center for Drug Evaluation and Research (CDER)? Some of the reporters wanted to connect the two events. They wanted me tell them, pundit-like, what this said about Commissioner Hamburg’s approach to integrity in decisionmaking and to allegations of wrong-doing.

I disappointed them.

I see no connections between the Schultz resignation and the leak of the Woodcock allegation. One was between Dr. Hamburg and Dr. Schultz and relates to the best interests of the agency going forward. The other is between an unhappy company and Dr. Woodcock and is being handled, appropriately, by the Inspector General. The Commissioner’s role, if any, would come later.

There are other important reasons to think the stories are unrelated. Over the past year, Dr. Schultz has faced a series of attacks on his stewardship of CDRH, including calls for his resignation. Whether innocent or guilty, he has been forced to operate in a beleaguered environment.

We do not know what Dr. Hamburg believes. We are told that the resignation was a joint decision. In any case, it falls within the discretionary authority of the Commissioner. They may have discussed the various charges when they met. More likely, the bulk of the conversation was about whether Dr. Schultz’s ability to lead has been compromised….or whether, under the circumstances, he is the right leader for a product area slated for intense review that may become a heated public and Congressional debate.

Dr. Hamburg has said that there will be changes in the leadership team. Several have already occurred. One or two of the departures may be a result of her commitment to high ethical standards. It is more likely that people will be replaced because:

  • Dr. Hamburg wants her own team, or
  • there are policy or personality conflicts, or
  • she has concerns about FDA being caught up in side-issues and personalities.

While there may have been more involved, this last reason is sufficient for Dr. Hamburg to want a change at the top of CDRH.

Dr. Woodcock’s situation is totally different. There is a single public complaint made by a company that fears it is losing a high-stakes competition for market entry. They are asking only that she recuse herself in the specific matter in which the two companies are involved.

The Inspector General’s investigation of Dr. Woodcock appears to be a routine response to these conflict-of-interest allegations. No one should pre-judge the situation until OIG has completed its report. I would expect Dr. Hamburg to do just that—wait for the report before deciding whether any action is needed.

The Schultz and Woodcock stories are interesting, albeit unfortunate. They are totally unrelated and tell us nothing about Dr. Hamburg’s approach to leading FDA.

I am sure we will hear more from Dr. Hamburg on FDA integrity and the FDA decisionmaking process. But that wasn’t this past week’s story….no matter how hard anyone tried to make it so.


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