Don’t Hold Your Breath for FDA

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The biggest existential drama in L.A.’s business scene right now is playing out in Valencia. That’s where Alfred Mann and his 440 employees at MannKind Corp. have been waiting for Godot … I mean, waiting for the FDA.

They’ve been more or less forced to twiddle their thumbs while the Food and Drug Administration dithers over making a decision about MannKind’s product, which is an inhalable insulin.

It’s a drama because a tremendous amount is riding on that decision. If it’s approved, the product could improve the lives of diabetics because they wouldn’t have to inject themselves, at least not as often. They could simply get their dose from a pocket-size inhaler.

And an approval would be terrific for the company. It would have control of a hot property. Mann has often said his inhalable insulin device, named Afrezza, could be one of the “most valuable products ever.”

Long-suffering stockholders would be rewarded perhaps by a doubling, maybe even tripling, of share prices, which have been in the $8-$8.50 range lately. And Mann, whose wealth the Business Journal estimated at $1.78 billion in May, would become a multibillionaire.

But if the product is denied, well, the opposite would occur. The stock would crater. The company’s prospects would dim considerably. Mann, who’s reportedly put close to $1 billion of his own money in the venture, would be a huge loser.

What’s complicating this drama is the fact that the FDA has taken years to make up its mind. Finally, in March, the FDA emerged to announce its decision. It said it decided to get a little more information and take more time. After that, it signaled that it would render a decision in late December. In late December, it said it would make a decision in late January.

No one knows what the FDA will do at the end of this month. But one analyst – and he’s an optimistic one – thinks there’s a 60 percent chance the FDA will want … still more time.

But for the company, time is the enemy. MannKind has no revenue and is running out of cash. Mann has fed the company, but he was set back with the 2008 bankruptcy of his aviation business, Eclipse, and even he cannot continue funding this endeavor forever. Mann, 85, was quoted in an article last month saying, “I have my limitations.”

Now you could make the argument that the FDA can take all the time it wants when it comes to safety. And that would be a fine argument. Except the product’s safety doesn’t seem to be much of a concern anymore. The FDA, after it’s satisfied with safety questions, routinely goes on to questions of efficacy and, well, who knows what it’s concerned about?

“What’s left for the FDA to decide?” asked health care writer David Whelan in a Dec. 30 Forbes online post.

For the FDA, and for bureaucracies in general, time is a friend. The more time it takes the less political risk it faces from making decisions. It has the right, the obligation, really, to get the information it needs to make sure new drugs are safe or at least reasonably so. But it shouldn’t have the right to sit on decisions for months and years on end, dawdling and yawning while companies hang on to their lifelines until they let go from exhaustion and plummet to the rocks.

I dream of a time when the FDA is forced to make decisions not in haste but in a reasonable time. That’ll happen shortly after Godot arrives.

Charles Crumpley is editor of the Business Journal. He can be reached at [email protected].

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