Thursday, May 28, 2009

Conspicuous Consumption: FDA Makes TB a Priority

Margaret Hamburg has only been on the job as commissioner of the Food & Drug Administration for two days, so it is obviously too early to pronounce on winners and losers in the Hamburg era. Except in one case: it already looks like the Hamburg years will be good ones for companies pursuing new therapies or vaccines for treatment of tuberculosis.

After all, Hamburg’s role two decades ago in combating drug resistant TB as New York public health commissioner was one of the defining elements of her resume when she emerged as the nominee for FDA commissioner. As she told the Senate HELP Committee during her confirmation hearing earlier this month, New York’s “rapid response to an epidemic of drug-resistant tuberculosis became the model worldwide.”

But it’s not just Hamburg talking about TB.

FDA’s new chief scientist—Jesse Goodman—highlighted a TB vaccine as an example for the need to focus on global public health priorities during a keynote address at the Food & Drug Law Institute annual meeting in April.

“There are billions around the world who clearly need an effective TB vaccine,” he said, citing an analysis by BIO Ventures for Global Health indicating that the market for such a vaccine would exceed $1 billion—even without sales in the US or other developed economies.

That’s not all: “If we had a highly safe and highly effective TB vaccine it would probably make sense to use it in this country,” Goodman added, noting “the chaos” that followed one traveler returning to the US with extremely drug resistant TB. That’s music to the ears of companies like Sanofi and GSK, which are developing TB vaccines. (You can read more of Goodman’s remarks to FDLI in The RPM Report.)

Then there is an upcoming meeting of FDA’s Anti-Infectives Drugs Advisory Committee June 3 to discuss “issues related to the development of drugs for the treatment of tuberculosis, including drug resistant tuberculosis.”

“Areas of discussion include diagnosis, treatment duration, study design (such as endpoints and duration of follow up) and safety issues,” the meeting announcement says. (We’ll have coverage of the meeting itself in The Pink Sheet next week.)

The meeting was announced by FDA March 12, one week after we broke the story of Hamburg securing the White House nod for FDA. We missed the coincidence at the time, but in hindsight it’s a clear indication of one priority for the new FDA leadership. (Yes, the TB meeting was being planned before Hamburg was picked—but then again, Hamburg was on the HHS transition team…)

A search of our Inteleos database shows at least 34 drugs and vaccines in development for TB. The Hamburg years should be good for those projects.

1 comment:

Anonymous said...

now is one of the most important times that we should be concerned about health and protecting the stability of our world. While the FDA worries about the vaccines and more serious problems of the world, I imagine that individually we could be doing things on our own to promote a healthier lifestyle.