Phase 2: FDA Guidance
March 14, 2018
Dear NCH Members,
Many of you have been anxiously awaiting the next step in responding to the Food and Drug Administration (FDA) Draft Guidance issue. We have been working along with the American Association of Homeopathic Pharmacists (AAHP) and other organizations to target an effective response to this serious situation.
Phase I of this strategy focused on states that have Members of Congress that sit on the committees that have oversight of FDA and its actions. The combined efforts of all homeopathy organizations resulted in 4500 letters that were sent to legislators in the target states!
These efforts prompted Senator Orin Hatch of Utah and Representative Ryan Costello of Pennsylvania to author letters to the FDA. Other legislators are being asked to sign onto these letters.
These letters request the Agency to incorporate key aspects of the current working guideline into new Draft Guidance it proposed in December 2017. In doing so, the new guidance will be more effective in guiding manufacturers to produce consistent, high-quality and safe homeopathic medicines and ensure you continue to have access to homeopathic medicines in your health care.
A HUGE THANK YOU to Americans for Homeopathy Choice President Paola Brown and her team, who visited 90 legislators’ offices in DC leaving information on the FDA issue, introducing legislators and their staff to homeopathy and distributing Washington Homeopathics remedy kits. They used their energy, time, and enthusiasm to raise awareness of homeopathy in Congress.
As a direct result of their efforts, Representative Andy Biggs from Arizona created a letter to the Appropriations Committee requesting that funding be withheld from the FDA to finalize the proposed Draft Guidance.
We are now ready to launch Phase II.
Don’t Let the FDA Needlessly Restrict Your Access to Homeopathic Remedies!
NCH is asking each of you to write your congressman today to ensure your favorite homeopathic medicines remain available to you, and thank you for your support!
SEND YOUR LETTER TO YOUR CONGRESSMAN NOW! The deadline is March 20th.
Below are the VoterVoice links that we are asking each of you to use. We are asking EVERY state senator and representative to sign on to the respective letters that Hatch and Costello (respectively) have agreed to send to the FDA.
Healthcare Professionals Link
****Please Note: States that have already received the link (CO, NM, TN, PA, UT, and WA) will not be able to submit through these links. Please contact your legislator directly.*****
Since the 2015 public hearing, the American Association of Homeopathic Pharmacists (AAHP) has been suggesting several ways to improve the CPG so that it addresses both industry’s and the agency’s concerns. AAHP’s view is that FDA has a responsibility to the American consumer to provide more clarity than the initial draft guidance provides. Specifically, AAHP will submit comments to FDA asking the agency to incorporate key aspects of CPG 400.400 into the new draft guidance, a solution that provides uniformity in enforcement and clarity in regulation. AAHP believes this will significantly help ensure Americans have the safest and highest quality products for the personal health care choice that they want and deserve.
NCH and indeed all of the homeopathy organizations are working together to present our concerns and opinions with a coordinated harmonious message and powerful voice and we need your help!