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about a unique opportunity we had to communicate with the President and his advisors because the FDA had submitted its Draft Guidance to the Office of Information and Regulatory Affairs (OIRA) which operates by law within the Executive Office of the President.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.
-
We were able to schedule a meeting with this office and it was scheduled for 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 According to OIRA, the office completed its review of the Draft Guidance as "consistent without change," meaning the office did not recommend any changes to the guidance.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. 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.
At this stage, we need to assume that the Draft Guidance is now quickly on its way to being finalized.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!
