Can a Defensive, Fire-Fighting (and Data Diving) FDA Be a Strong and Effective Enforcer?

As reported recently by Phil Taylor in Securing Pharma, Leaders of the House Energy and Commerce Committee (I won't name any political parties) have written to FDA Commissioner Hamburg, demanding that FDA release documents from its prior, extensive investigations into U.S. heparin supply chain safety.
They make a very strong case, since 80% of the heparin sourced by the U.S. involves Chinese suppliers and manufacturers at some point.

But instead of having the Agency revisit the past, wouldn't demanding proof of the assurance of the quality of existing and incoming U.S. supplies, from industry, be enough?

Are we heading for a political environment in which FDA will continually be put on the defensive and prevented from improving and enforcing? An era full of "Acting" titles and stopgap measures?

Yes, the Agency needs to be kept on its toes, but as its managers prepare for defensive data dives, the entire industry becomes more vulnerable to new, unexpected supply chain threats and other risks.

In addition, will FDA abandon or make headway on any of the ambitious improvement programs it has begun if its resources continue to be channeled into efforts like this?
FDA is often criticized for its inadequate IT and lack of transparency. What will happen to initiatives designed to solve these problems?

I'd been planning to interview an FDA official on its IT projects, progress on some of which is summarized in this recent self-assessment from CDER.

Then I learned that FDA's rather recently appointed CIO Lori Davis left FDA in January for a job in private industry. Joe Albaugh is Acting CIO.

One also wonders what will happen to the whole Transparency Initiative, which Commissioner Hamburg has publicly supported, but which, with Dr. Sharfstein's departure, now lacks a change agent. That program itself required the development of novel IT and reporting vehicles. More resources wasted?

Under discussion as part of the Transparency Intiative was requiring that more confidential data from industry be shared----information that would allow the public to know, not only how well FDA is doing its job, but how effective the industry has been at developing new drugs. Click here for one possible scenario for which FDA was soliciting comments, and here for an interim report on the effort.

Transparency, and informed consumers, are good for the industry. So is an FDA that is proactive, and on the offensive...rather than forced to defend past actions and anticipate new ones.

So, maybe this heparin letter is just a single case, and not the start of a chain of events. What do you think?

AMS

 

 

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