FDA Comment Period Extended!

Dear NCH Members,


If you haven’t yet contacted your legislators to comment on the FDA Draft Guidance, you have more time! The FDA has extended the comment period for 60 days. It is very important to write your legislators and ask them to co-sign either Senator Orin Hatch’s letter or Representative Ryan Costello’s letter. (SEE BELOW) These letters to the FDA are asking to merge the existing CPG 400.400 (Compliance Policy Guide) for manufacturing homeopathy medicines that has been in place for over 30 years with the new Draft Guidance. 

These contacts to your own legislators are the most important thing you can do for homeopathy in this issue. 

The FDA has ignored consumer comments but it is expected that they will take Congressional opinions more seriously, especially those coming from the committees that oversee the FDA.  Senator Hatch is a ranking member of the Senate’s Committee on Health, Education, Labor and Pensions that oversees the FDA.
Representative Costello is a member of the Committee on Energy and Commerce subcommittee on Oversight and Investigations that oversees the FDA from the House.

https://energycommerce.house.gov/subcommittees/oversight-and-investigations-116th-congress   If your legislator is a member of either of these committees, be sure to contact them! All legislators are welcome! Of course, you are free to post a personal comment on the FDA comment page if you choose, but please make your comments respectful, professional and on message. https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2017-D-6580 

The extension is for an additional 60 days.  We expect the FDA will be updating their site to accept public comments in the next few days. NCH, along with other homeopathy organizations, will be posting a letter on the FDA comment page. HOW TO CONTACT YOUR LEGISLATORS (from the AAHP) 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 https://www.votervoice.net/AAHP/campaigns/57691/respond

Consumer Link

https://www.votervoice.net/AAHP/campaigns/57654/respond (These states (CO, NM, TN, PA, UT, and WA) will not be able to submit through these links. Please contact legislators 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!