AAHP protects industry interests

Townsend Letter for Doctors and Patients,  July, 2004  

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In April of 2003, one of the actions taken by Mr. Mark McClellan, the still somewhat new Commissioner of Food and Drugs, was to direct the FDA to clear its docket of proposed rules and actions which had not been made final. Among these FDA docket items is the FDA's response to a 1979 Citizen's Petition submitted by the AAHP requesting that homeopathic drugs be exempted from final product testing for active ingredients.

In July of 1979 the AAHP submitted the petition to amend the then newly adopted Current Good Manufacturing Practices (cGMP) regulations by exempting homeopathic drugs from the requirements in 21 CFR[section]211.165(a) requiring the laboratory testing of finished drug products to determine conformance to specifications for identity and strength of the active ingredients. The AAHP noted that the request was impractical for homeopathic drugs because of the highly diluted nature of the active ingredients in the finished dosage forms. It was pointed out that the FDA had exempted other drug products from certain impractical requirements and the significant economic impact the requirement would have on the homeopathic pharmaceutical industry. In 1983 the FDA responded in the Federal Register that the arguments in the petition were well founded and would be granted, however the action was never adopted as a final rule.

The AAHP in July 2003 submitted comments to the FDA requesting that this interim enforcement policy which has applied for 20 years not be allowed to expire with the publication of a final rule withdrawing the 1983 proposal. As presented to the FDA over 20 years ago this would create a substantial economic burden and an absence of public health benefit. We respectfully requested that the FDA finalize the 1983 proposed rule.

Jay Borneman, Chairman of the Regulatory Committee, worked with Al Lorman, AAHP Council, who submitted the original Citizen's Petition in 1983, to draft the comments in time to have them approved by the Board and submitted ahead of the July deadline. The Board recognizes this as an important issue for our entire industry and will continue to keep the membership informed as progress occurs.

American Association of Homeopathic Pharmacists

33 Fairfax Street

Berkeley Springs, W. Virginia 25411 USA

Phone/Fax: 800-478-0421

info@homeopathyresource.org

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