Pharma's Market

Published: Tuesday, 10 Nov 2009 | 2:46 PM ET

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When I went to the FDA's Web site today I was surprised to see on the homepage a link to a letter written by Commissioner Dr. Peggy Hamburg. It's addressed to "Dear Healthcare Professional" aka a "Dear Doctor letter." That's a common type of communication from the agency and/or companies to the medical community, usually when they've got bad news to pass along about a drug or device. It's pretty rare for the commish to write one.

AP

Dr. Hamburg is weighing in on the H1N1 vaccine. She writes, "We are not cutting any corners. Just as for seasonal influenza vaccine, no lot of the 2009 H1N1 vaccine can be used until it has been carefully evaluated and released as sterile and potent by both the manufacturer and the FDA."

After weeks of taking it on the chin from outspoken skeptics of the vaccine's safety, it looks to me like there's a concerted effort between the government and industry to go on the offensive. Or is it the defensive?

First, Sanofi-Pasteur

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[SNY  Loading...      ()   ] opened up its American vaccine manufacturing plant for the first time to TV cameras. Among the things the company was able to show off was a sophisticated contraption with more than a dozen cameras inside of it that take pictures of vaccine-filled vials and syringes from every which way looking for defects. It then spits out the rejects. On CBS' "60 Minutes" and a few days later on CNBC and MSNBC, SNY was also able to show how clean its clean rooms are. I'm not sure how far that will go towards silencing the critics, but at least one of the vaccine makers is starting to open up and to try to demystify the previously closely guarded process. It's my understanding the company is doing an even bigger media tour of the plant tomorrow.

And now, the head honcho of the FDA is getting involved in the effort.

Dr. Hamburg points out that, "Although a gap still remains between the demand for the vaccine and the currently available supply, this is the first time in history that any vaccine has been available at the time that an influenza pandemic has struck." Maybe federal health authorities, who've been holding at least one news media briefing a week on H1N1, think that their repeated statements about the vaccine's safety and efficacy aren't getting as much traction as they'd like. Last week, I saw a medical doctor on the TV show "Extra" of all things (No, I don't normally watch it. I just got sucked in for some reason) saying, "It's only been tested for three weeks."

As I've written before, I'm not endorsing the H1N1 vaccine or vouching for its safety. As much as I hate shots, I don't like being sick even more. And people I know who've had H1N1 have been miserable. So, when the supply is sufficient enough to allow those of us who are not considered high priority to get the vaccine, I still plan on rolling up my sleeve.

• Why Health Care Bill Is Facing Such a Tough Fight in Senate
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