FDA March 30th FDA update by Califf about vaping regs

[sofarsogood]

This blog page covers a number of topics including vaping, posted today. Doesn't look like they've backed down on anything. Califf, a man of science? Bah humbug.

Priorities – Teamwork to Achieve Common Goals | FDA Voice

• tobacco product deeming. Much effort has gone into developing the framework for the approach to the regulation of the broad array of tobacco products. FDA is working hard to finalize the deeming rule, which in its proposed form would extend FDA regulation over virtually all tobacco products, including electronic cigarettes, either all cigars or all but premium cigars, pipe tobacco, certain dissolvables that are not “smokeless tobacco,” gels, and waterpipe tobacco.

 

[Rossum]

Correct me if I'm wrong here, but didn't they send the finalized regulations to the OMB for review? If so, it seems to above would imply that the OMB kicked it back to the FDA as unacceptable?

 

[sofarsogood]

Correct me if I'm wrong here, but didn't they send the finalized regulations to the OMB for review? If so, it seems to above would imply that the OMB kicked it back to the FDA as unacceptable?

This is the first feedback I've seen from any government agency in a position to say anything official. I'm not sure what it means. But now our distinguished panel of experts can pick it apart.

 

[Lessifer]

I don't see anything new in that. The deeming, since being published, was for all tobacco products including cigars, or all tobacco products including cigars but not premium cigars. Sure, you could argue the nuance of the words used, but they only thing I'm taking away is, not finalized yet. Whatever that means.

 

[Rossum]

Wouldn't it have been finalized, at least in the FDA's mind, before they sent it to the OMB for review late last year?

But now they're back to finalizing some more?

 

[Lessifer]

Wouldn't it have been finalized, at least in the FDA's mind, before they sent it to the OMB for review late last year?

But now they're back to finalizing some more?

Depends on whether they consider "final" to be when they release it, or it becomes law. I would assume the latter.

 

[squee]

The lead in to that says "a number of specific critical issues are on my front burner this morning and will remain there for the foreseeable future:"


Doesn't sound like finalization is imminent and it's already been 5 1/2 months since it was kicked over to OMB

 

[Lessifer]

It would be fan-freaking-tastic if this process were more transparent...

 

[nicnik]

Priorities – Teamwork to Achieve Common Goals | FDA Voice

FDA is a science-based, science-led organization that focuses on the needs of patients and consumers; protecting their well-being is our charge as a public health agency. The state of the art as it pertains to understanding the needs and choices of patients and the public is progressing rapidly, and we must continue to keep pace by incorporating the best methods for taking patient preferences, experiences, and outcomes into account in every part of our work... ... ... ...

... ... ...Accordingly, FDA is thoroughly committed to working with the many partners in our ecosystem to help build and sustain an infrastructure that produces the high-quality scientific evidence needed to guide FDA’s decisions about the drugs, medical devices, tobacco products, and food products it’s charged with regulating, as well as the decisions that healthcare providers, patients, and consumers make about their health and well-being... ...

blah, blah, blah...

Actions speak louder than words...

 

[sofarsogood]

blah, blah, blah...

Actions speak louder than words...

My parable of medicine.
The richest man on earth spends his entire fortune on developing one pill. He's sitting on the curb, in the street, in shabby clothes. He's broke. A nurse comes out of a building and gives him the pill. He takes the pill. He dies anyway.

That's what the FDA represents to me. They don't protect us from snake oil. They just make it more expensive. Then a chinese guy in a garage finds a cure for one of the world's biggest public health problems. It's simple, effective and doesn't cost the government a dime. The FDA wants to kill it as fast as possible. If the FDA were abolished I wouldn't miss them. At least I'd have some money left at the end.

May be Mr. Califf used to be a scientist.

 

[SeniorBoy]

I think it's understandable that "we" are all waiting ANXIOUSLY for a formal resolution to the Deeming. I read the Blog post and IMHO it's just Califf introducing himself after his recent final confitmation as the new Commissioner and "pounding his chest" and bloviating about the great things he will do / insert / large /gag

Having watched with great interest his conformation hearing I'm not at all surprised at this press release Blog post and his propensity to bloviate, shade, vagness, etc. The bottom line for me is I don't see anything in his Blog post to warrant any valid assumptions or even a rational guess about the current state of the Deeming and the actions of OMB. Of course that's only my view and others can read the tea leaves and we can all have fun doing it.