The FDA Needs a Bake Sale

Dear President-elect Obama,

Among the many other issues facing you, I have a suggestion for your selection of the new chief of the Food and Drug Administration. How about Brian Gallagher, the president and CEO of United Way, or maybe Yale's director of annual giving, Karri Brady?

Do they have a background in drugs or food? Not that I know of, but I'm sure they're both pretty good at raising money.

And money seems to be at the root of the problem with the FDA right now. It's pretty clear that PDUFA fees, even though they're up to over $1 million per marketing application, aren't enough to get things done in a timely manner.

Just take a look at some of the delays drugmakers have experienced this year with their marketing applications:





Eli Lilly (NYSE: LLY  )

Original PDUFA at the end of June, but still no word on approval


Theravance (Nasdaq: THRX  )

Original PDUFA date of July 21, but still no word on approval


CV Therapeutics (Nasdaq: CVTX  )

Delayed over three months before approval


Johnson & Johnson (NYSE: JNJ  ) and Medarex

Delayed three months before FDA asked for more information


Ligand Pharmaceuticals and Pfizer (NYSE: PFE  )

PDUFA date pushed back three months to January 2009

Those delays result in real costs for the companies and patients. Not only do companies lose potential revenue while they wait, but it's a little hard to hit the ground running with marketing when you don't know when a drug will be approved. Further, patients are denied receiving potentially beneficial medications in a timely manner.

Yes, Mr. Obama, you could just hire a scientist and fund the agency at a reasonable level, but I know you've got better things to spend my tax dollars on, like bailing out the likes of General Motors (NYSE: GM  ) and Citigroup (NYSE: C  ) . So please take my suggestion under advisement. Get someone in there who knows how to hold bake sales. That's the only way drug investors are going to get back to the old semi-predictable FDA that made investors some serious dough.

Brian Orelli, Ph.D.
Foolish Drug Investor

Pfizer, Eli Lilly, and Johnson & Johnson are Motley Fool Income Investor recommendations. Pfizer is an Inside Value selection, and the Fool owns some shares. CV Therapeutics is a Rule Breakers pick. Try any of our Foolish newsletters today, free for 30 days.

Fool contributor Brian Orelli, Ph.D., prefers cookies to cake. He doesn't own shares of any company mentioned in this article. The Fool's disclosure policy tastes better with milk.

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