Biotech Mailbag: Who Will Run FDA?

Bad choice. Nissen, to me, seems more interested in political grandstanding than actually getting things done. Yes, he's been a vocal advocate on drug safety, but perhaps too zealously, to the point that the FDA may never approve another drug again under his watch. That's not the kind of FDA commissioner investors want.

My pick would be Scott Gottlieb. He's a medical doctor and worked directly under Mark McClellan when he was FDA commissioner. Gottlieb is a free market Republican in the American Enterprise Institute mold. Gottlieb and I know each other; in fact, there are few people in the Wall Street-biotech industry-media sphere who don't know Gottlieb.

Gottlieb and I disagree politically on most things, but he knows the FDA and understands drug development really well. He'd get stuff done there, and return credibility and assertiveness to the agency -- stuff missing for a long time.

President-elect Obama, call me. We can discuss. I also have some advice on that puppy you promised Sasha and Malia, if you need it.

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Onward. Norm F. writes "Zymogenetics (ZGEN) had an oral presentation of a small trial for their PEG-Interferon lambda. If you attended, or heard anything, it would be good to know."

I was in San Francisco at the liver disease meeting and did see the data presentation on PEG-Interferon lambda in treatment-experienced hepatitis C patients. The data were encouraging, but early. Still, I can understand why Zymogenetics is excited about the drug, it definitely has the potential to be safer and better tolerated than the currently marketed PEG-interferons for hepatitis C.

A lot more work needs to be done on PEG-Interferon lambda. I'd also note that the hepatitis C treatment market is evolving. The use of PEG-interferon (a long-acting immune system booster) is not going away soon, but the development of direct antiviral drugs like Vertex's (VRTX) telaprevir or Pharmasset's (VRUS) R7128 may one day allow doctors to stop using interferons when treating hepatitis C patients. That may be especially true if combinations of direct antivirals are found to be effective.

So, Zymogenetics is developing PEG-Interferon lambda at a time when there are beginning to be the early signs of a diminishing market for such drugs in hepatitis C. I don't want to overstate this point because interferons will remain part of hepatitis C treatment in the near future. I'm just saying that if doctors had strong drugs to replace interferons, they'd use them. And drugs like that are under development today.