Friday, April 3, 2015

How the FDA and Wall Street Strangle Medical Innovation and What Startups Need to Know

“The Man Who Fought the FDA and Won” Shares Survival Skills for an Environment Hostile to Innovation

By Marc Dresner, Senior Editor, IIR

It’s a dream-turned-nightmare scenario.

Your little company has developed a breakthrough product that in an exceedingly rare feat has met every primary and secondary clinical end point set out in a binding protocol agreement with the FDA.

You file for what you assume will be a straightforward approval and the FDA arbitrarily—and illegally—denies your request because some political winds have shifted inside the agency.

What would you do?
Dr. Joe Gulfo

If you’re Dr. Joe Gulfo, you take the fight to Madison Square Garden.

“The man who fought the FDA and won”—as he’s often called these days—says the only way to take on the agency is to do so very publicly.

But first, he'd strongly suggest you avoid fighting with the FDA at all.

“The FDA can wait you out.”

“The FDA can wait you out. Little companies will run out of money,” said Gulfo.

“We’ve gotten to a point now where policy is more important than patients,” he added.

Gulfo actually faced this situation not once but twice—at two different startups with products that performed impeccably in their respective clinical trials and that were subsequently derailed despite having met conditions for approval that the FDA had already agreed to.

In the second instance, Gulfo initiated a public battle with the FDA, which ultimately caved and granted approval.

Gulfo won, yes, but it would be a hollow victory. Delays devastated both companies.

“We were collateral damage.”

“New leadership at the FDA came in and they wanted to basically re-do the whole device center. We were collateral damage,” Gulfo said of MELA Sciences, the company he took to war with the FDA.


For a very large pharmaceutical company like, say, Merck, an FDA about-face might constitute an expensive but manageable disappointment.

But for the small companies and startups that today comprise the backbone of the drug and medical device innovation pipeline, Gulfo says even a hiccup with the FDA can be catastrophic because investors don’t have the stomach for it.

“What does a little company do when the FDA moves the goal post? I can’t raise money. I can’t partner. I can’t do anything.”

“Most of the time innovation really happens in small companies. One-product companies are especially vulnerable,” said Gulfo.
“What does a little company do when the FDA moves the goal post? I can’t raise money. I can’t partner. I can’t do anything if you do that to me,” he told Inside Clinical.
“So, we did what we had recourse in the law to do,” he continued. “We filed a supervisory request, we elevated the optics, and the FDA did not like that.”
The FDA didn’t cop to its mistake; it dug in its heels and tried to impugn the research. Stock plummeted, key investors jumped ship…

In fact, when Gulfo disputed the decision publicly, the FDA didn’t cop to its mistake; instead, the agency dug in its heels and tried to impugn the research. 
MELA’s stock plummeted, key investors jumped ship…
In this podcast for Inside Clinical—the official interview series of the 24th Annual Partnerships in Clinical Trials conference—Dr. Gulfo recounts his ordeal and imparts survival tips for small biopharmas in a regulatory and financial environment that can be downright hostile to innovation.

Editor’s note: Dr. Joe Gulfo will present “Picking up the Pieces of Clinical Trial Failure: How I Battled the FDA and Won” at the 24th Annual Partnerships in Clinical Trials Conference running April 22-24 in Boston.
For more information or to register, please visit www.clinicaltrialpartnerships.com 
Ps. Pick up a copy of “Innovation Breakdown: How the FDA and Wall Street Cripple Medical Advances” at www.innovationbreakdownbook.com


ABOUT THE AUTHOR
Marc Dresner is IIR USA's senior editor and special communication projects lead. He is the former executive editor of Pharma Market Research Report, a publication for market researchers in the pharmaceutical industry. He may be reached at mdresner@iirusa.com. Follow him @mdrezz.




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