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SupermansJustice

How we can get GEN-003/Pritelivir..and other treatments faster

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SupermansJustice

Hello all, 

Would like to bring your attention to the following article. 

Quote

According to Emily Ellsworth, a writer and former Congressional staffer, reaching out via things like Facebook or Twitter aren’t going to be very effective. Staffers check these mediums occasionally, but they’re largely ignored. Sending letters is more helpful, but they also get so many letters that it’s impossible to give them individual attention. The best way to get in touch? Phone calls.

As Emily explains in a detailed tweet chain, phone calls have to be dealt with when they occur and they can’t be ignored. A large volume of phone calls can be overwhelming for office staffers, but that means that their bosses hear about it.

Which office you target also matters. Members of Congress have offices in DC, but they also have offices in their home district that they represent. Target your letters and phone calls to your local office and you’ll have an easier time getting their attention. And while it should go without saying, only contact your representatives. While there may sometimes be a reason to reach out to certain people who don’t represent you (especially if they’re in a leadership position), it will always be most effective to talk to the person that represents your district. You can read the entire tweet chain at the source link below, or check out Emily’s follow up video with some FAQs here.

Source: http://lifehacker.com/the-best-ways-to-contact-your-congress-people-from-a-f-1788990839

So if we want GEN-003/Pritelivir - we are going to need to do this ourselves. I don't think contacting state reps will be super helpful for this matter in particular, but I do think it will be helpful if we send mail/call the FDA.

We would need to pick one or two people (not too high on the food chain)

We would need to all call within 1-2 days of each other (could call anonymously if need be) to have the greatest important

Who is in?

 

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SupermansJustice

Yeah - I can't see why not - you don't have to say where you're from :)

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moialbalushi

Then let is do it man. Im in. We just need to decide what are the important things to say first. 

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SupermansJustice
6 hours ago, moialbalushi said:

Then let is do it man. Im in. We just need to decide what are the important things to say first. 

I agree

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SupermansJustice
16 minutes ago, hurryup said:

Who do I write man? FDA address? I'm in.

https://www.fda.gov/AboutFDA/ContactFDA/

 

https://www.fda.gov/RegulatoryInformation/Dockets/Comments/default.htm

this last one is huge:

"

Petitions submitted to FDA must contain:

  • Action requested--What rule, order, or other administrative action does the petitioner want FDA to issue, amend or revoke?
  • Statement of grounds--The factual and legal grounds for the petition, including all supporting material, as well as information known to the petitioner that may be unfavorable to the petitioner's position.
  • Environmental impact--This information is generally required if the petition requests approval of food or color additives, drugs, biological products, animal drugs, or certain medical devices, or for a food to be categorized as GRAS (generally recognized as safe). Procedures for preparing environmental impact statements can be found in Title 21, Part 25 of the Code of Federal Regulations. If an environmental impact statement is not required, petitions should include a statement to that effect.
  • The following official certification statement --"The undersigned certifies, that, to the best knowledge and belief of the undersigned, this petition includes all information and views on which the petition relies, and that it includes representative data and information known to the petition which are unfavorable to the petition."
  • Identifying information-- The petition must be signed and include the petitioner's address and phone number.

In addition, some petitions may require information on:

  • Economic impact--This information is required only if FDA requests it after review of the petition.

FDA currently does not accept e-mailed petitions. Petitions can be sent electronicially to FDA via www.regulations.gov at http://www.regulations.gov/#!documentDetail;D=FDA-2013-S-0610-0001 or must be mailed or delivered to the Division of Dockets Management, Food and Drug Administration, Room 1061, 5630 Fishers Lane, Rockville, MD 20852.

Ultimately, FDA management decides whether to grant a petition. But first, agency staffers evaluate it, a process that may take several weeks to more than a year, depending on the issue's complexity. After FDA grants or denies the petition, the agency will notify the petitioner directly. If not satisfied, the petitioner can take the matter to court.

For more information on submitting petitions, and sample formats, consult Title 21 of the Code of Federal Regulations, Sections 10.3010.33, and 10.35.

Besides accepting public comments and petitions, FDA also schedules public meetings and hearings to discuss and explain its proposals. These usually are held with industry representatives or consumer groups, but anyone interested may attend and, with advance notice, may comment on a proposal. Meetings often are held in the Washington, D.C., area, but sometimes are set in other areas across the country. Meetings for the public to present views are announced in the Federal Register.

Questions about the comment, petition or hearing process should go to FDA Dockets Management, (240) 402-7500. Hours are 9 a.m. to 4 p.m., Eastern time, Monday through Friday"

they only get 200 petitions a year - that's nothing. We have a serious chance at making a change. Spread the fucking word ASAP and get this petitioned signed

 

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SD777
23 minutes ago, SupermansJustice said:

https://www.fda.gov/AboutFDA/ContactFDA/

 

https://www.fda.gov/RegulatoryInformation/Dockets/Comments/default.htm

this last one is huge:

"

Petitions submitted to FDA must contain:

  • Action requested--What rule, order, or other administrative action does the petitioner want FDA to issue, amend or revoke?
  • Statement of grounds--The factual and legal grounds for the petition, including all supporting material, as well as information known to the petitioner that may be unfavorable to the petitioner's position.
  • Environmental impact--This information is generally required if the petition requests approval of food or color additives, drugs, biological products, animal drugs, or certain medical devices, or for a food to be categorized as GRAS (generally recognized as safe). Procedures for preparing environmental impact statements can be found in Title 21, Part 25 of the Code of Federal Regulations. If an environmental impact statement is not required, petitions should include a statement to that effect.
  • The following official certification statement --"The undersigned certifies, that, to the best knowledge and belief of the undersigned, this petition includes all information and views on which the petition relies, and that it includes representative data and information known to the petition which are unfavorable to the petition."
  • Identifying information-- The petition must be signed and include the petitioner's address and phone number.

In addition, some petitions may require information on:

  • Economic impact--This information is required only if FDA requests it after review of the petition.

FDA currently does not accept e-mailed petitions. Petitions can be sent electronicially to FDA via www.regulations.gov at http://www.regulations.gov/#!documentDetail;D=FDA-2013-S-0610-0001 or must be mailed or delivered to the Division of Dockets Management, Food and Drug Administration, Room 1061, 5630 Fishers Lane, Rockville, MD 20852.

Ultimately, FDA management decides whether to grant a petition. But first, agency staffers evaluate it, a process that may take several weeks to more than a year, depending on the issue's complexity. After FDA grants or denies the petition, the agency will notify the petitioner directly. If not satisfied, the petitioner can take the matter to court.

For more information on submitting petitions, and sample formats, consult Title 21 of the Code of Federal Regulations, Sections 10.3010.33, and 10.35.

Besides accepting public comments and petitions, FDA also schedules public meetings and hearings to discuss and explain its proposals. These usually are held with industry representatives or consumer groups, but anyone interested may attend and, with advance notice, may comment on a proposal. Meetings often are held in the Washington, D.C., area, but sometimes are set in other areas across the country. Meetings for the public to present views are announced in the Federal Register.

Questions about the comment, petition or hearing process should go to FDA Dockets Management, (240) 402-7500. Hours are 9 a.m. to 4 p.m., Eastern time, Monday through Friday"

they only get 200 petitions a year - that's nothing. We have a serious chance at making a change. Spread the fucking word ASAP and get this petitioned signed

 

Great work man, I'm in

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Franticheart

 

Quote
  • Action requested--What rule, order, or other administrative action does the petitioner want FDA to issue, amend or revoke?
Quote

2. Ask the FDA to consider moving along trials (keeping safety in mind) for treatments that can help decrease transmission and outbreaks

Do we need to expand on this in regards to what we want the fda to do, i.e:  lifting the clinical trial hold on Pritelivir for one 

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