March 13, 2013

@ldtimmerman: If You’ve Got a Real Breakthrough, the FDA Wants To Talk

An insightful article from healthcare journalist Luke Timmerman about the FDA's Breakthrough Therapy designation here.

"Several investors I’ve spoken to are optimistic, or at least cautiously optimistic, about what will happen if the FDA truly follows through on this directive to advance breakthrough therapies.

“We as an industry have been going after lower-risk, more incremental products because the incentive structure was there,” says Bob More, a general partner with Frazier Healthcare Ventures. But the incentives are changing, and moving away from incrementalism. Insurers have gotten more aggressive in asking whether new drugs are really adding value to the healthcare system. The FDA’s new emphasis on breakthrough medicines is consistent with the kind of products that insurers have also been clamoring for, More says.

While I know some in the industry are cynical about whether the FDA means what it says, I think we’re seeing the FDA’s actions are speaking as loud, and maybe louder, than its words. Last year, the FDA approved the most new drugs in 15 years. Those actions, the new law, and what looks like a new attitude all appear to be fostering innovative new drug development. It’s good news for the industry, and patients."

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