Please help (again!) by 12/7 to save our access to homeopathic remedies (date: 12/3/2022)

[JenniferC]

Tell FDA Draft Guidance Fails to Regulate Homeopathic Medicines in Accordance With the Law

Tell the FDA that the Draft Guidance fails to regulate homeopathic medicines in accordance with the law.

homeopathychoice.org

We are writing with an urgent request and to give you an important update. We need your help yet again to submit another comment, but this time we are back to sending them to the FDA. These comments help our grassroots team show Congress the massive number of people who commented on the FDA's docket...there are tens of thousands who both support homeopathy and also oppose the FDA's Draft Guidance!

Last Chance To Tell FDA​

Let me review events over the last few days: Over Thanksgiving week, we reached out to you about a unique opportunity we had to communicate with the President and his advisors because the FDA had submitted its Draft Guidance to the Office of Information and Regulatory Affairs (OIRA) which operates by law within the Executive Office of the President. Thank you for your support in submitting comments to this office and to the President as we sought a meeting. The turn of events after we sought this meeting shocked us. We were able to schedule a meeting with this office and it was scheduled for yesterday (Tuesday) morning. Not only was the meeting scheduled, but it was confirmed and we received the teleconference meeting details. But on the morning of the meeting-literally hours before we were scheduled to meet with OIRA-I was notified that the meeting was canceled. Why? According to OIRA, the office completed its review of the Draft Guidance as "consistent without change," meaning the office did not recommend any changes to the guidance. This is the reason they gave for canceling our meeting. Furthermore, the review was completed in about 7 business days. This is unusual because not only does the office have 90 days to complete the review but they also have a lengthy set of criteria they need to review. This indicates they would need time to properly review any document submitted to OIRA. The office seemed to be in a big hurry to determine that the guidance was not economically significant, that it had no international impacts, that small entities would not be affected, and more. Oh, and of course, they made these conclusions without meeting with any stakeholders in the homeopathy community, like Americans for Homeopathy Choice. As you can imagine, we feel these conclusions are categorically false. The guidance has and does impact each of these areas and more. Together with our attorneys who have years of experience with this type of scenario, I find the rushed timing of their regulatory review puzzling. It also seemed clear to us that OIRA had no real desire to meet with us, which they would have done had they not concluded their review so quickly.

Last Chance To Tell FDA​

You already know that the Draft Guidance is anything but "reasoned." At this stage, we need to assume that the Draft Guidance is now quickly on its way to being finalized. With your help, we have held it off for almost 5 years, but now this may be our final opportunity to tell the FDA that their guidance fails to regulate homeopathic medicines in accordance with the law. Please take action by December 7! We don't know how long it will take the agency to make its next move, so the sooner we communicate our concerns, the better! Our goal is to reach 40,000 comments by this deadline! We need you to join in our efforts because your voice will change history. You are needed now more than ever! Forward together for choice and good health, - Paola Brown, President Americans for Homeopathy Choice P.S. Please forward this message to anyone you can think of who cares about continued access to homeopathic medicines!!!

 

[Dr. Jeff]

Yes!!

Please submit the form at the link above (even if you already did). Americans For Homeopathy Choice needs our support more than ever.

Thanks Jennifer for sharing this important email from Paola!