The Food and Drug Administration's (FDA's) current regulation of homeopathic drugs provides sufficient, substantial oversight of these products, according to testimony presented by AHPA at a public hearing held by FDA April 20 to 21.
The FDA hearing, Homeopathic Product Regulation: Evaluating FDA's Regulatory Framework After a Quarter-Century, was held to gather input on appropriate regulatory policy for homeopathic medicines.
AHPA's testimony, presented by Will Woodlee, partner at Kleinfeld, Kaplan, and Becker LLP, highlighted several points that demonstrate the adequacy of FDA's current regulatory framework for homeopathic medicines in protecting public health and ensuring consumer access to safe products.
Woodlee stressed that, under the existing framework, companies are required to register their facilities and to list their drug products with FDA, which, along with other investigative and surveillance tools, provides the agency with the means to identify manufacturers, marketers, and products as candidates for education, administrative action, or enforcement action, as necessary or appropriate.
The current regulatory framework also provides FDA with sufficient information on adverse events associated with over-the-counter (OTC) homeopathic drug products to allow the agency to protect the public health, according to AHPA's testimony. Manufacturers are required to maintain records of all adverse events reported to them and must maintain records and reports regarding complaints. When required, firms must investigate those complaints and, upon request, make their files available during FDA inspections.
"Through inspections of manufacturing establishments and investigations of mandatory reports of serious adverse events associated with homeopathic drug products, FDA currently has the ability to investigate potential safety issues and take any indicated follow-up action in a timely manner," Woodlee testified. "Indeed, FDA historically has used its tools and authorities to address perceived issues involving homeopathic drug products, including 'recommending' and overseeing recalls as well as issuing warning letters."
Woodlee also noted that FDA's existing regulatory framework for homeopathic drug products appropriately reflects the small safety risk inherent to these highly diluted products. In addition, AHPA is not aware of any data indicating that consumers perceive appropriately marketed OTC homeopathic drug products as substitutes for prescription drugs, and AHPA believes FDA currently has adequate enforcement authority to address any OTC homeopathic drug products that are inappropriately marketed for non-OTC indications or without adequate directions for use.
"In light of the adequacy of the existing regulatory framework for OTC homeopathic drug products, AHPA urges FDA not to increase regulatory burdens on manufacturers of such products, which could limit consumer choice and access to self-care products that, in some cases, have been available for many decades," Woodlee concluded.