who will the new director of FDA be

[Guest guest]

This article originally posted December 16, 2008 and appeared in

Issue 447

Change at the FDA

Kliff, Publisher, Diabetic Investor, has been looking at the

President-elect's recent appointments and keeps wondering who will be the

new head the

Food and Drug Administration. Whoever it is will have an interesting road

ahead of them.

Change at the FDA

Kliff, Publisher

As President elect Obama continues to build his cabinet, one of the most

important positions open is just who will head the Food and Drug

Administration.

Although not a cabinet level post whoever takes the job will face a host of

issues. The agency has publicly acknowledged they are under-staffed,

under-funded

and ill-equipped to handle the approval of new drugs and medical devices.

Novo Nordisk (NYSE:NVO) has already experienced the agency's inability to

function when their panel meeting for liraglutide was pushed back a month.

While

this may not seem like a big deal, each delay is potentially costing Novo

millions of dollars and allows Amylin (NASDAQ:AMLN) an opportunity to

strengthen

sales of Byetta.

Amylin too is being impacted by the slowdown at the agency as they anxiously

are awaiting news on what type of label change the agency will require for

Byetta. The folks in San Diego are also curious as to how an agency in

transition will be able to handle the NDA for the once-weekly version of

Byetta,

Byetta LAR. As everyone knows, assuming the label change to Byetta is not a

Black Box, LAR is the key to Amylin's future. It's quite possible that

Amylin

will be ready to go but the agency won't be. While this would not be a

negative reflection on Amylin there's no question their share price would be

impacted.

While no one knows who will be the new commissioner a name being thrown

around is Nissen, chief of cardiovascular medicine at the Cleveland

Clinic.

If that name sounds familiar it should, Dr. Nissen was at the center of the

Avandia controversy. Should Dr. Nissen get the job Diabetic Investor

believes

this would have a dramatic impact on the approval process for diabetes

drugs.

Lost in all this concern over the drug approval process is the equally

important impact this appointment will have on medical devices. Recently the

FDA

meet with industry leaders from insulin pump and continuous blood glucose

monitoring companies to discuss how pumps and CGMS are approved. At this

meeting

the agency basically acknowledged they are not able to handle the approval

process as they lack the necessary expertise. Given the move towards closed

or semi-closed loop insulin delivery systems this admission by the agency

sends a dangerous signal.

Are we headed back to the days when patients scream bloody murder that the

approval process is overly burdensome and preventing new drugs and devices

from

reaching the people who need them? This would not be unrealistic given that

the strongest compliant heard over the past few years is that the agency is

too close to the companies they are supposed to regulate. Rarely in

Washington does the pendulum swing to the center when change comes.

Diabetic Investor understands that we're in the midst of one of the most

serious economic crisis seen in our lifetime. The economy is in a recession

that

is likely to last well into next year. However, recessions don't last

forever and as bad as things seem today the economy will recover. Let's

hope for

that President elect Obama has the good sense not to ignore the importance

of the FDA top spot. While this may not be on top of his list of priorities

his decision here will have a lasting impact. Choose wisely Mr. President

elect.

www.diabetesincontrol.com

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