FDA and Tobacco: Yes, They’re Serious

We’ve been writing for some time now that the new Administration is acting as if giving the Food & Drug Administration the authority to regulate tobacco is a foregone conclusion.

The nomination of Bill Corr (recently of Campaign for Tobacco Free Kids) as deputy secretary of Health & Human Services was a big clue. And so was the emergence of Margaret Hamburg as the expected nominee to head FDA itself.

Each time we mention it, the reaction from our biopharma readers is the same: “You have got to be kidding me.”

The notion of giving FDA the authority to regulate tobacco is “an idiotic idea that is utterly at odds with FDA's mission to protect the public health,” one former industry attorney who has recently joined private practice wrote. “Aren't there enough broken parts at FDA that need fixing now without the distraction of tobacco? Wow.”

That pretty well captures the biopharma industry view. They want FDA to have the leadership and resources to tackle the regulatory mission it already has—without the distraction of building a whole new mission at the same time.

Its time for industry to face facts: Congress and the new Administration are indeed serious about making tobacco regulation part of what FDA does.

How serious?

Wendell Primus, senior policy advisor to Speaker of the House Nancy Pelosi, told Avalere Health’s Diabetes Forum yesterday that a tobacco regulation bill is “next up” for the House.
Not the next FDA item up. Not the next health care item up. Next. Before stem cells, the budget, energy, and health care reform (in that order).

Primus later highlighted tobacco regulation as very much a part of health care reform, in discussing the importance of wellness and prevention as part of that initiative.

The House bill will be marked up today in the House Energy & Commerce Committee, chaired by Henry Waxman who championed FDA’s last efforts to assert regulatory jurisdiction over cigarettes under Commissioner David Kessler. (You can read the Washington Post’s preview here; note that the only objections seem to be from public health advocates who say the measure isn’t tough enough on tobacco companies.)

So, like it or not, expect FDA to have a major new regulatory role in the near future.