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Post by prcgorman2 on Jul 15, 2021 6:38:00 GMT -5
Excerpt from FDA Acknowledgment letter: "The petition was received and processed under CFR 10.30 by this office on 07/08/2021 and assigned docket number FDA-2021-P-0714. Please refer to this docket number in future correspondence on this subject with the Agency. Also, note that the acceptance of this petition for filing is a procedural matter and in no way reflects the agency’s decision on the substantive merits of the petition.I’ve noticed that some of the large telco companies and telco trade associations have filed petitions in the last year looking for FCC to back off of some of their decisions on rule making regarding some arcane robocall regulations. It’s not the same as what’s going on here with FDA, but what I think may be drawn from it is that federal regulatory agencies are under no obligation to even respond to petitions. They can be filed, but it doesn’t mean squat will get done about it. Since the FDA has already made deprecatory comments about these kinds of “citzen” petitions, I think it’s likely the petition is a Hail Mary and almost certainly associated with Liquidia or a shareholder of theirs. I’m not going to lose sleep over it. |
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Post by stockwhisperer on Jul 15, 2021 7:22:52 GMT -5
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Post by sweedee79 on Jul 15, 2021 7:40:25 GMT -5
Imo.. a "client" should not be allowed by law to hide behind an attorney!!!! Just unbelievable.. Very precious and fiercely protected are 'privileged communications' under the law and consistently upheld. A couple of others besides attorney/client...clergy/parishioner, spouse/spouse, doctor/patient, and maybe two more I can't think or right now. This isn't about privileged communications... When a lawyer represents me I am named.. If I file a complaint I am named.. not once have I ever been able to complain and hide... |
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Post by sweedee79 on Jul 15, 2021 7:56:16 GMT -5
Not only that but the FDA should.be allowed to know who is behind this..
Lawyers generally don't have to hide who they are representing... That speaks volumes as to the integrity of this petition..
Citizen petitions weren't created or intended as a tool for attorneys representing pharmaceutical companies who then hide.
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Post by stockwhisperer on Jul 15, 2021 8:08:11 GMT -5
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Post by Clement on Jul 15, 2021 8:42:50 GMT -5
from the article: “One of the anticompetitive tactics we’ve been concerned with involves companies submitting certain types of citizen petitions in order to delay FDA action on a generic or other abbreviated application,” FDA Acting Commissioner Ned Sharpless, MD, said in a statement. “While the FDA has rarely delayed specific drug approvals because of citizen petitions, there’s no doubt these shenanigans can burden the drug review process.” The final guidance, Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act, describes what constitutes a 505(q) petition and some of the factors the FDA will consider in determining whether a petition is submitted with the primary purpose of delaying the approval of a drug application. If the agency determines that this is the case, the FDA will consider whether the petition can be denied on that basis and may note this determination in the petition response, which is posted publicly. The agency believes this will provide an additional deterrent to pursuing these tactics. Citizen petitions are an avenue for any interested party to ask the FDA commissioner to change agency regulations or take—or refrain from taking—an administrative action. In the case of drug makers, such requests may include asking the FDA not to approve a generic or biosimilar product unless certain conditions are met. The Food and Drug Administration Safety and Innovation Act, enacted in 2012, holds that approval of a pending drug application must not be delayed because of a citizen petition’s request for action (unless the petition convinces the FDA that a delay is needed in order to protect the public health). However, citizen petitions have nonetheless been the subject of controversy, as they require significant time and resources for the FDA to address. Among many stakeholders, there exists a consensus that brand-name drug makers could (and sometimes do) use these petitions to forestall competition from generic or biosimilar drugs. During the FDA’s 2017 meeting on administering the Hatch-Waxman amendments, numerous stakeholders raised the question of whether citizen petitions filed by brand-name drug makers could be used to forestall competition. |
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Post by hellodolly on Jul 15, 2021 8:59:23 GMT -5
Very precious and fiercely protected are 'privileged communications' under the law and consistently upheld. A couple of others besides attorney/client...clergy/parishioner, spouse/spouse, doctor/patient, and maybe two more I can't think or right now. This isn't about privileged communications... When a lawyer represents me I am named.. If I file a complaint I am named.. not once have I ever been able to complain and hide... Great points. I digress. I don' think this applies. |
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Post by cedafuntennis on Jul 15, 2021 9:27:35 GMT -5
This isn't about privileged communications... When a lawyer represents me I am named.. If I file a complaint I am named.. not once have I ever been able to complain and hide... Great points. I digress. I don' think this applies. it will be that the company paid the lawyer to file the CP in there lawyers name just not to have to be named. Since anyone can file this CP, why not? |
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Post by mango on Jul 15, 2021 9:37:58 GMT -5
I submitted a FOIA request to FDA. Hopefully I will receive the name of the unnamed “client” and the locked exhibits. I’ll keep ya’ll updated.
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Post by peppy on Jul 15, 2021 10:02:43 GMT -5
I submitted a FOIA request to FDA. Hopefully I will receive the name of the unnamed “client” and the locked exhibits. I’ll keep ya’ll updated. You are so good at this. Thank you. |
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Post by sweedee79 on Jul 15, 2021 10:33:43 GMT -5
Yes.. Thank you Mango for tirelessly fighting for us!!!♥️♥️
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Post by mango on Jul 15, 2021 16:27:15 GMT -5
Here’s the FDA acknowledgment email for the FOIA request. Hopefully we get somewhere with this, if not, oh well, was worth the try.  |
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Post by awesomo on Jul 15, 2021 16:44:09 GMT -5
Thanks mango, if it gets to the point of charging a fee, I'm sure a bunch of us would be willing to chip in.
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Post by oldfishtowner on Jul 16, 2021 8:01:03 GMT -5
Sounds like Shkreli to me.
From UTHR 01-28-21 press release: "United Therapeutics Corporation (Nasdaq: UTHR) announced today that that the BREEZE study of Tyvaso DPI (inhaled treprostinil) met its primary objective of demonstrating safety and tolerability in patients with pulmonary arterial hypertension (PAH) transitioning from Tyvaso (treprostinil) Inhalation Solution." What else is there to say?
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Post by Chris-C on Jul 16, 2021 10:34:52 GMT -5
Here’s the FDA acknowledgment email for the FOIA request. Hopefully we get somewhere with this, if not, oh well, was worth the try. The FDA does not know who the petitioner is, as the petition was filed by a law firm that will honor its attorney client confidentiality obligation or risk its legal standing with DC bar. The fact that the petition was filed in this manner diminishes its credibility and screams the type of abuse the FDA loathes. Generally, petitions with merit are offered by known sources who have respected credentials and offer information that is compelling and novel, not rehashed data that has already been considered and found to be lacking. If it makes you feel better, Fight fire with fire. Anyone can petition with a rebuttal to every point made in the Lassman submission, as there is no rule against filing a petition that is supportive of a pending NDA. In the end, petitions mainly create noise, and they no doubt arrive somewhat discredited if they are from anonymous sources with unknown credentials. Heck, even Martin Shkreli signed his own letter and acknowledged he was shorting MNKD in his infamous letter preceding a CRL delay for MNKDs NDA. The target here is UTHR- and the circumstances are vastly different. I doubt that UTHR is losing any sleep over this whatsoever. They tend to do their homework and don’t squander certificates for expedited reviews. This smells like a “Hail Mary” by unethical competitors or hedgies, submitted by a lawyer who acts as a regulatory communication agent on behalf of anyone if the fees are paid and the action is not illegal. The “anonymous” client bears responsibility for the content and I suspect they signed a document attesting that the information is factual. Whether it has persuasive merit is a quite different matter. Besides, safely and effectively helping people with PAH is the objective here. I feel confident that the FDA will keep this foremost in mind when approving the NDA. |
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