AAHP Submits Comments to US Congress on Safety Standards for Homeopathic Drug Products

The following is the text if a letter submitted to Senators Harkin and Enzi of the Senate Health Education, labor and Pensions Committee.

March 29, 2012

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The Honorable Tom Harkin
Chairman
Senate Committee on Health, Education, Labor and Pensions
Washington, DC 20510
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The Honorable Michael Enzi
Ranking Member
Senate Committee on Health, Education, Labor and Pensions
Washington, DC 20510

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Re: Drug Supply Chain Integrity

Dear Chairman Harkin and Ranking Member Enzi:

The American Association of Homeopathic Pharmacists (AAHP), the 89-year-old trade association of the principal manufacturers and distributors of homeopathic medicines in the United States, is pleased to have this opportunity to offer its views on the Senate HELP Committee Draft for Stakeholder Discussion of the proposed legislation on Drug Supply Chain Integrity. The AAHP commends the Working Group for taking the leadership in producing this draft of legislation that can have an important impact on the health of Americans. The AAHP would also like to express its appreciation to the Working Group for circulating a Draft for Stakeholder Discussion. The issues addressed by this proposed legislation are highly technical and complex and the absence of stakeholder input could easily result in legislation with significant negative unintended consequences.

The Association’s 30 corporate members employ over 1,000 people in more than 20 states, and provide approximately 2,000 different homeopathic low-cost medications to the public and to homeopathic physicians. Since the passage of the Federal Food, Drug, and Cosmetic Act in 1938, homeopathic medicines have been classified and regulated as drugs by the Food and Drug Administration. The Homeopathic Pharmacopoeia of the United States is recognized as an “official compendium” pursuant to Section 201(j) of the FD&C Act. The overwhelming majority of homeopathic drugs are sold over-the-counter.

The AAHP has reviewed the March 16 draft legislation and finds much in it that the Association supports. The AAHP particularly supports the proposed requirement that the electronic drug listing and registration database be inter-operable with other FDA databases. Many of our member companies which import products from abroad have found in the past that documents submitted to FDA are either lost or misfiled such that products were stopped at the border while the company refilled documents that had originally been submitted to FDA years ago.

The AAHP also supports the proposed requirement that FDA inspections be risk-based. While current law mandates regular inspections of manufacturing facilities, FDA has never had the ability to conduct all the required inspections. A risk-based approach is a wise solution to a recurrent problem. One AAHP member company had an imported product suddenly barred from the U.S. on the ground that the foreign manufacturer had not been inspected for seven years (although the facility had current inspection certificates from the appropriate European authorities).

The AAHP generally supports the safety standards for imported drugs that would be imposed by Section 12 of the legislation, but it is concerned that the demands of FDA in applying this provision could easily become a significant trade barrier to smaller companies which manufacture homeopathic drugs. A large pharmaceutical company may import several dozen products, so it can readily respond to any FDA request. A company which manufactures and exports to the U.S. relatively small quantities of hundreds of drugs may have a very different idea as to what constitutes a reasonable request from FDA.

Many homeopathic medicine manufacturers are relatively small companies and many produce a range of products that is an order of magnitude greater than the number of products by multi-billion dollar companies.

Accordingly, we are especially interested in the as-yet-released draft of Section 18 of the proposed legislation, Drug Distribution Security. We look forward to working with the Working Group to develop legislation that helps assure the integrity of the drug chain supply while at the same time recognizing that not all drug manufacturers produce products that pose the same level of risk to consumers or generate the dollar volume that may be required to implement over-reaching supply chain requirements. Just as the Working Group adopted a risk-based approach for FDA inspections, we believe that a similar approach should inform supply chain requirements. We would welcome an opportunity to meet with the Working Group to discuss how best to protect consumers while at the same time preserving their option to purchase a large number of low-volume homeopathic products.

Very truly yours,

Mark Land
President