April 5, 2014

Stanton A. Glantz, PhD

FDA Prioritizes Tobacco Industry Needs Over Public Health

On April 4, 2014, the FDA announced that it will review all "regular" substantial equivalence submissions by tobacco companies immediately, responding to industry complaints that the process is taking a long time.  (A substantial equivalence application is one in which the company claims that a new product they want to market is "substantially equivalent" to one already on the market so there is no need for a full new product review.  As I noted before substantial equivalence is a huge loophole in the law .)
 
It is understandable why the industry wants regular SE applications processed quickly, since “Regular SE applications” are for products that did not enter the market between Feb. 16, 2007 and March 21, 2011, SE reports were filed after March 22, 2011, and which can not be marketed until FDA determines that they are substantially equivalent. 
 
The new announcement says that FDA had received 981 “regular SE reports” before March 31, 2014, and of these, they have reviewed 23.6% of them (by my arithmetic, 232).  Thus, the remaining 749 cannot be marketed until FDA makes an SE determination.  This announcement said that from now on (or actually from March 24 on), the FDA will review regular SE applications immediately (any SE application applied for now would be a “regular application”, because it is after March 22, 2011). 
 
That sounds reasonable, except for the fact that of the 3,517 "provisional SE applications” for products that were placed on the market after Feb. 15, 2007 for which the companies had submitted SE applications by March 22, 2011, there remain 3,513 provisional SE applications that the FDA has not yet issued a determination.  (They have denied just 4 applications, on February 21, 2014.)  These products can continue to be marketed unless FDA issues a "not substantially equivalent" order.  That means that these 3,513 products can remain on the market essentially indefinitely without any FDA review, since the FDA will be kept busy with the "regular" applications.
 
The reality is that the only reason that a tobacco company would bother changing a product is to increase sales, which will, as a natural outcome, increase population-level harm.  So the FDA presumption should be against substantial equivalence claims.
 
The FDA had been doing the right thing by dealing with the backlog of provisional applications first.  This change will only benefit Big Tobacco.
 
All the SE applications are at http://www.accessdata.fda.gov/FDATrack/track?program=ctp&id=CTP-OS-total-product-submissions-received&fy=all

Comments

Comment: 

Almost five years since the passage of the FSPTCA,  the FDA has done almost nothing to promote tobacco control.  I'm close to giving up on them entirely.  And i don't think the key decisions are being made by the FDA.  These are political decisions, and the buck stops in the Oval Office (via the White House Office of Information and Regulatory Affairs).  The relentless right wing attack on Obama (for just being) has distracted our attention from the fact that he has been no friend of public health. We need to wake up and do our best to put pressure on Obama to get with the program.  Complaining about the FDA won't do the trick - it makes it sound like the problem is with a bunch of faceless bureaucrats (and what can you ever do about them?) rather than the politically accountable President. Nor can we let the fact that many of us know and respect folks at the FDA stop us from trying to hold Obama accountable - I have to assume that they are as frustrated as we are.
Dick Daynard

Comment: 

Dr. Glantz, you have the clout, write an article in a major American newspaper calling out the administration!
 
No one can do that but you! So...

Comment: 

Fine. Point taken. I agree.
So: which public health group has demanded publicly that Obama let FDA do its job?
It has also been almost five years of thundering silence from every major health group in America regarding FDA's inaction on tobacco. There's no reason Obama should act here: it's free for him to do nothing, exactly as he has been. It's not like any health group known to the public will be calling him out on it.
All those major national groups who were cheerleaders for Kennedy-DeWine; where are they now?
Jon Krueger
 

Comment: 

If he did that, the story would be "activist says FDA not moving fast enough on tobacco, blames Obama".
The story needs to be "FDA is not doing its job on tobacco and Obama is why, says every health group you've ever heard of".
Jon Krueger
 

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