New FDA Commissioner - Change or More of the Same

The media has it wrong, as usual.

When the media discusses a new commissioner they say the old FDA approved unsafe drugs. That is absolutely not a true portrayal of the problems at the FDA.

It’s that kind of irresponsible reporting that has caused Congress and much of America to be on the wrong page. It has also helped to create a risk adverse FDA.

Every time some approved drug later shows any safety issue, no matter how small, it makes the network news.

You never hear about the drugs that should be approved and are not, like Provenge.

If we continue to allow the dialogue to continue as it is, we are in danger that a new FDA will be even more risk adverse. Anyone whose hat is in the ring, and talks about the FDA becoming more safety conscious, does not get it!!

If President Elect Obama appoints Janet Woodcock to head the FDA, then his message of change has lost some of its meaning.

The next FDA commissioner needs to be more citizen friendly. He/she needs to be strong enough to make needed changes, changes which will be strongly resisted by the entrenched bureaucrats at the FDA, like Richard Pazdur.

Don’t believe the FDA is unfriendly? Try calling them and ask if you can be updated on the CareToLive Citizen Petition pending without decision since July 2007. They will treat you rudely!

The next commissioner needs to be more compassionate, more understanding of the issues faced by terminal patients and their families. They must understand that the U.S. is no longer the leader in health care in the world, and must want to change that. They must have a desire to bring about a more transparent and accountable FDA.

They need to be able to admit to agency mistakes (everybody makes them) and rather than try to bury the mistakes, they must allow the agency to learn from them, FIX THEM and grow. Often to do the right thing, an agency has to be willing to admit that it previously did the wrong thing, which the current administration absolutely will not do. Janet Woodcock has never admitted to any mistake, and if you ask her today, she will tell you that she does not see where the agency has made any mistakes.

The next commissioner must also be strong enough to keep Pazdur in his place so he does not go over to CBER, sabotage their Advisory Committees, and then bully and threaten the head of CBER to get his way when he is angry that he is not assigned the review of immunotherapies.

Andrew von Eschenbach has been weak and unwilling to do anything, other than to make empty promises and grandstanding speeches, that were never backed up by action. Most of all, the new commissioner needs to instill a sense of responsibility and humanity into the agency. The new commissioner must surround himself with employees who have a lick of common sense, and can use it when weighing risk/benefit. They need to admit that they currently are unable to assess innovative new treatments and actually listen to the AC experts they bring in, unbiased experts who should be without conflicts of interest.