Mark Land, AAHP President

 

In February, the White House released the President’s Fiscal Year 2021 Budget. Correspondingly, each agency publishes a detailed budget justification. Monitored by AAHP’s longtime Washington-based lobbyist, the Food and Drug Administration’s (FDA) 430-page budget justification mentions homeopathy twice: Download full budget justification here.

 

  1. Pages 38–39: Extend the Requirement for Field Alert Reports (FAR) to Non-Application Distributed Drug Products. One of FDA’s legislative proposals is to require FARs for the many drug that are not marketed under an approved application. This would include homeopathic drugs as well as other drugs. These reports are part of an early warning system to protect patient health and the quality of therapeutic products.AAHP supports improvements to protect public health and views this as a way to improve the safety of homeopathic medicine. Homeopathic manufacturers are encouraged to learn about and understand these requirements.

 

  1. Page 378: “Homeopathic Draft Guidance” is listed eighth under significant items reported by the House Committee. The document reads: “The Committee urges FDA to consider the views of patients in finalizing its draft guidance.” A response by FDA summarizes the agency’s call for initial comments, revisions to the draft, and current call for comments on the revisions. (The wrong deadline is listed for submitting comments.)AAHP provided a draft of its comments to the association’s members prior to the association’s membership meeting on March 6 for a group discussion. Final comments will be submitted to FDA prior to the agency’s May 23 deadline.

 

The two mentions of homeopathy in the budget is significant in that this document serves as a statement of future priorities and highlights previous key activities.

 

Through its Washington-based partners, AAHP will continue to monitor FDA and work with targeted members of Congress on committees who oversee the agency to ensure that policies contribute to both our members and our consumers.

 

Please let me know if you have any questions or concerns.

 

All the best,

Mark Land, AAHP President