FDA Pillsbury Co. v. FTC - History Repeats Itself?

[zoiDman]

Interesting article in Forbes about the potential Unethical Influence of Congress over the FDA regarding the PMTA process.

Lawmakers’ Pressure On FDA Review Of New Tobacco Products Blurs Line Between Oversight And Undue Influence

 

[YoursTruli]

Wow that is an interesting read. Maybe there are more eyes on this than imagined and for different reasons.

 

[zoiDman]

There is a Lot Going On right now. From Many different angles.

I used to Post a Lot of it in the Deeming Thread. But kinda just Gave Up. That Thread used to be a Place where people would at least try to stay On Topic. But those days have been Gone for a Long Time.

 

[YoursTruli]

There is a Lot Going On right now. From Many different angles.

I used to Post a Lot of it in the Deeming Thread. But kinda just Gave Up. That Thread used to be a Place where people would at least try to stay On Topic. But those day have been Gone for a Long Time.

Too many soapboxes being dragged about seizing any sliver of opportunity regardless of the actual topic.
I am really glad you posted this. It's a great article with a different insight and perspective. I did watch hearings throughout the past years including the one with Woodcock, which wasn't a hearing it was a verbal beating, discussing really. She was going to say and commit to what they wanted, period, it was brutal.
Maybe....
Janet Woodcock Ruled Out for Top FDA Job, Sources Say
"The Biden administration has decided it won’t nominate acting Food and Drug Administration Commissioner Janet Woodcock to lead the agency on a permanent basis, according to people familiar with the situation, who say the White House is now focused on a shortlist of other potential candidates."

I have wondered a lot it anyone denied will put up a fight considering how much they already put out for PMTAs. Would it even be financially possible Or beneficial to them in the long haul, because I think it would be a very long haul.

 

[zoiDman]

Janet Woodcock was always viewed as being an Uphill Battle for a Senate Confirmation. She carries a Lot of Baggage at a time when a more Bipartisan confirmation is needed.

There were also many Whisperings about Her being way to Independent and having "Sharp Elbows" to work under Becerra's HHS.

 

[zoiDman]

Too many soapboxes being dragged about seizing any sliver of opportunity regardless of the actual topic.
I am really glad you posted this. It's a great article with a different insight and perspective. I did watch hearings throughout the past years including the one with Woodcock, which wasn't a hearing it was a verbal beating, discussing really. She was going to say and commit to what they wanted, period, it was brutal.
Maybe....
Janet Woodcock Ruled Out for Top FDA Job, Sources Say
"The Biden administration has decided it won’t nominate acting Food and Drug Administration Commissioner Janet Woodcock to lead the agency on a permanent basis, according to people familiar with the situation, who say the White House is now focused on a shortlist of other potential candidates."

I have wondered a lot it anyone denied will put up a fight considering how much they already put out for PMTAs. Would it even be financially possible Or beneficial to them in the long haul, because I think it would be a very long haul.

BTW --- Kinda Dry Reading, but here is what is Making people a little twitchy in Washington.

https://www.gsa.gov/cdnstatic/Vacancies_Reform_Act_1998.pdf

"§3346. Time limitation "

(a) Except in the case of a vacancy caused by sickness, the person serving as an acting officer as described under section 3345 may serve in the office- "(1) for no longer than 210 days beginning on the date the vacancy occurs;

And Woodcock I believe was named the Acting FDA Commissionaire on the day that Biden was sworn in. January 20th, 2021.

 

[Vapeon4Life]

Interesting article in Forbes about the potential Unethical Influence of Congress over the FDA regarding the PMTA process.

Lawmakers’ Pressure On FDA Review Of New Tobacco Products Blurs Line Between Oversight And Undue Influence

Read it - And all I see from it is HOPE !

Now I ask is it time to form a 'non-profit' legal foundation to protects the rights of vape manufacturers from capricious and arbitrary enforcement of PMTA regulations ???

".......FDA’s PMTA approval process is more adjudicative than it is rulemaking. The eventual outcome, a marketing or denial order, arises from a formal process based on a formal record, applying legal standards set in advance on a case-by-case basis. Thus, a plaintiff suing FDA would only need to show Members of Congress’s action cast doubt on the PMTA process’ impartiality.

The lawmakers’ pressure campaign on PMTA review featured multiple messages and messengers, as compared to the one Senate hearing in Pillsbury. And rather than Senators merely implying that FTC should have ruled differently in its Pillsbury case, Senators and Representatives over the past year have clearly demanded negative outcomes for specific PMTA applicants and dictated which factors should matter most during application reviews.

****

For many of the PMTA applicants, an FDA denial effectively puts them out of business. That reality certainly creates a strong incentive for legal challenges. How ironic if Members of Congress’s own words and deeds undo what they campaigned so aggressively for: FDA’s removal of ENDS products from the market."

So Senators like Dick Durtbin, et al: {from same article}

" Members of Congress—several of whom co-sponsored the 2009 Tobacco Control Act—have stage-managed a pageant of outrage over ENDS that has featured committee hearings, press conferences, and information requests and letters to FDA. While those are common tools of legislative oversight, the Members’ ENDS pressure campaign may have stepped over the line between oversight and impermissible interference with agency adjudication. "

It has been said: "Don't get angry - Sue the .......s" !

Now while there is still time can we have some unity and form a legal foundation to fight back ?!?!

 

[WorksForMe]

It has been said: "Don't get angry - Sue the .......s" !

Now while there is still time can we have some unity and form a legal foundation to fight back ?!?!

Well Timelord, if you can figure out how to make that work, we're all ears. Some of us here have been watching this BS for years. We've signed petitions, written to our congress critters, made phone calls and donated to worthy causes. A few even marched on Washington. None of this accomplished much. Frankly, I'm kind of burned out.

There have been several lawsuits over the years. The last two that I know about were appealed to the Supreme Court. Of course, the Supreme Court wouldn't hear the cases. The last one was by the Pacific Legal Foundation, a nonprofit law firm.


.

 

[Vapeon4Life]

Well Timelord, if you can figure out how to make that work, we're all ears. Some of us here have been watching this BS for years. We've signed petitions, written to our congress critters, made phone calls and donated to worthy causes. A few even marched on Washington. None of this accomplished much. Frankly, I'm kind of burned out.

There have been several lawsuits over the years. The last two that I know about were appealed to the Supreme Court. Of course, the Supreme Court wouldn't hear the cases. The last one was by the Pacific Legal Foundation, a nonprofit law firm.
.

Yes it is discouraging - But what suddenly got me interested again in possible legal remedy was the new case
mentioned at the beginning of this post:

Lawmakers’ Pressure On FDA Review Of New Tobacco Products Blurs Line Between Oversight And Undue Influence

Of course the problem is how do you get someone interested in a product just because it is much less harmful than the product it is designed to replace? Probably you would have to prove an ulterior motive {pay-offs, bribes, and/or campaign donations} that are driving your better product off the market and out of business. We know it is probably happening - Proving it is another story though "Undue Influence" is in itself significant.